ClinicalTrials.gg
CompletedNCT03294616Updated Nov 26, 2019

Transcutaneous Electroacupuncture for Gastric Complications of Scleroderma

An interventional study of transcutaneous electroacupuncture in Scleroderma and Gastroparesis, sponsored by Johns Hopkins University. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-11-26.

Sponsored by Johns Hopkins University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 6 months after the study started (first participant enrolled Feb 2017, registered Aug 2017).

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Phase
Not applicable
Study type
Interventional
Enrollment
23
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-15

Among 153 studies in Scleroderma, Diffuse with a site in United States — 29 open to participants now, 39 under way, 5 of them phase 3. Scleroderma, Diffuse · United States.

Enrollment
67th of 120
23 · median 29
Started
2017
with 5 others
No phase
22 of 153
2 open now
Registered
83rd of 153
by date
Lead sponsor
8 of 153
Johns Hopkins University

Among the 153 studies in Scleroderma, Diffuse with a site in United States, this one is the 67th largest by enrollment of the 120 interventional ones that give a count, is one of 6 that started in 2017, is one of 22 with no phase, and was the 83rd registered.

Scleroderma, Diffuse

310 studies on the registry are indexed under Scleroderma, Diffuse; 76 are open to participants now.

Browse Scleroderma, Diffuse studies →

Open to participants now

29 of the 153 studies in Scleroderma, Diffuse with a site in United States are open now. Recruiting first, the newest first:

24 more — sign in →

All 29 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 55 Scleroderma, Diffuse studies recruiting now, 28 (51%) set no upper age limit and 20 (36%) stop at 75 or younger; 10 take children under 18; 10 take healthy volunteers.

This study: 18 Years and older · all sexes · healthy volunteers too.

The full table on the hub →

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02

Study summary

An innovative method of needleless transcutaneous electroacupuncture (TEA) using a newly developed watch-size stimulator is proposed. Weak electrical current will be delivered via skin surface electrodes to acupuncture points related to gastrointestinal functions. The stimulator can be attached to the skin near the acupuncture points and therefore daily activity of the patient does not need to be altered. Two experiments are designed to prove the feasibility of the proposed therapy for gastric complications of Scleroderma .

03

Conditions studied

  • Scleroderma
  • Gastroparesis

Keywords

  • transcutaneous electroacupuncture
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • No any systemic diseases;
  • no scleroderma; no history of gastrointestinal surgery;
  • no dyspeptic symptoms during the past 2 weeks;
  • not taking any medications except during the past 2 weeks;
  • age 18 and older.

Exclusion criteria

Exclusion Criteria:

  • History of any systemic diseases or surgeries;
  • allergic to adhesives; pregnancy;
  • unable to sign the consent form.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
23 participants (actual)

Study arms

  • Experimental
    scleroderma patients-0

    for acute study: The experiment in patients will be performed in 4 randomized sessions on separate days (at least 3 days apart): one control session with sham-TEA and 3 TEA sessions at various parameters. TEA will be applied on both acupoints ST36 and PC6; the following sets of parameters will be tested for TEA at ST36: A) standard parameters: the set used in the previous SSc study: 25 Hz, 0.3ms, 2s-on and 3s-off; B) same as A but pulse width of 0.6ms; C) same as B but 0.1s-on and 0.4s-off. For TEA at PC6, 25 Hz will be replaced by 100Hz because TEA at PC6 is used to treat symptoms and 100Hz is believed to be better than 25Hz. The patient will be fasted overnight, and the test will last 2 hours (1 hour fasting and 1 hour postprandial).

    Device: transcutaneous electroacupuncture

  • Experimental
    scleroderma patient-1

    for chronic study: 2 weeks of Sham transcutaneous electroacupuncture treatment, 2 weeks of wash out, 2 weeks of transcutaneous electroacupuncture/Sham transcutaneous electroacupuncture treatment. Best parameter gained from acute study will be used.

    Device: transcutaneous electroacupuncture

  • Experimental
    scleroderma patients-2

    for chronic study: 2 weeks of transcutaneous electroacupuncture treatment, 2 weeks of wash out, 2 weeks of transcutaneous electroacupuncture/Sham transcutaneous electroacupuncture treatment. Best parameter gained from acute study will be used.

    Device: transcutaneous electroacupuncture

Interventions

  • Devicetranscutaneous electroacupuncture

    Weak electrical current will be generated by the device and delivered via skin surface electrodes to acupuncture points related to gastrointestinal functions

    Also known as: TEA

06

What researchers measure

Primary outcomes

  1. effect of TEA on symptoms in Systemic Sclerosis (SSc) patients

    On the first visit; The validated UCLA SCTC GIT2.0 ("University of California at Los Angeles Scleroderma Clinical Trials Consortium Gastro-Intestinal Tract Instrument version 2.0") for SSc will be the primary outcome measurement; it includes 7 categories: reflux, distention and bloating, fecal soilage, diarrhea, social functioning, emotional well-being and constipation

    Time frame: 1 day

  2. effect of TEA on symptoms in Systemic Sclerosis (SSc) patients

    On the second visit; The validated "University of California at Los Angeles Scleroderma Clinical Trials Consortium Gastro-Intestinal Tract Instrument version 2.0" (UCLA SCTC GIT2.0) for SSc will be the primary outcome measurement; it includes 7 categories: reflux, distention and bloating, fecal soilage, diarrhea, social functioning, emotional well-being and constipation

    Time frame: 28 days

  3. effect of TEA on symptoms in Systemic Sclerosis (SSc) patients

    On the third visit; The validated UCLA SCTC GIT2.0 ("University of California at Los Angeles Scleroderma Clinical Trials Consortium Gastro-Intestinal Tract Instrument version 2.0") for SSc will be the primary outcome measurement; it includes 7 categories: reflux, distention and bloating, fecal soilage, diarrhea, social functioning, emotional well-being and constipation

    Time frame: 42 days

  4. effect of TEA on symptoms in Systemic Sclerosis (SSc) patients

    The validated UCLA SCTC GIT2.0 ("University of California at Los Angeles Scleroderma Clinical Trials Consortium Gastro-Intestinal Tract Instrument version 2.0") for SSc will be the primary outcome measurement; it includes 7 categories: reflux, distention and bloating, fecal soilage, diarrhea, social functioning, emotional well-being and constipation

    Time frame: 70 days

  5. effect of TEA on symptoms in Systemic Sclerosis (SSc) patients

    Scleroderma Health Assessment Questionnaire will be used to assess SSc symptoms

    Time frame: 1 day

  6. effect of TEA on symptoms in Systemic Sclerosis (SSc) patients

    Scleroderma Health Assessment Questionnaire will be used to assess SSc symptoms

    Time frame: 28 days

  7. effect of TEA on symptoms in Systemic Sclerosis (SSc) patients

    Scleroderma Health Assessment Questionnaire will be used to assess SSc symptoms

    Time frame: 42 days

  8. effect of TEA on symptoms in Systemic Sclerosis (SSc) patients

    Scleroderma Health Assessment Questionnaire will be used to assess SSc symptoms

    Time frame: 70 days

  9. effect of TEA on symptoms in Systemic Sclerosis (SSc) patients

    SF-36 questionnaire will be used to assess general quality of life

    Time frame: 1 day

  10. effect of TEA on symptoms in Systemic Sclerosis (SSc) patients

    SF-36 questionnaire will be used to assess general quality of life

    Time frame: 28 days

  11. effect of TEA on symptoms in Systemic Sclerosis (SSc) patients

    SF-36 questionnaire will be used to assess general quality of life

    Time frame: 42 days

  12. effect of TEA on symptoms in Systemic Sclerosis (SSc) patients

    SF-36 questionnaire will be used to assess general quality of life

    Time frame: 70 days

  13. effect of TEA on symptoms in Systemic Sclerosis (SSc) patients

    a validated method including 9 symptoms will be used to assess GI symptoms

    Time frame: 1 day

  14. effect of TEA on symptoms in Systemic Sclerosis (SSc) patients

    a validated method including 9 symptoms will be used to assess GI symptoms

    Time frame: 28 days

  15. effect of TEA on symptoms in Systemic Sclerosis (SSc) patients

    a validated method including 9 symptoms will be used to assess GI symptoms

    Time frame: 42 days

  16. effect of TEA on symptoms in Systemic Sclerosis (SSc) patients

    a validated method including 9 symptoms will be used to assess GI symptoms

    Time frame: 70 days

Secondary outcomes

  1. effects of TEA on gastric motility

    visit 1 in acute phase; gastric slow waves recording

    Time frame: 1 week

  2. effects of TEA on gastric motility

    visit 2 in acute phase; gastric slow waves recording

    Time frame: 2 weeks

  3. effects of TEA on gastric motility

    visit 3 in acute phase; gastric slow waves recording

    Time frame: 3 weeks

  4. effects of TEA on gastric motility

    visit 4 in acute phase; gastric slow waves recording

    Time frame: 4 weeks

  5. effects of TEA on autonomic function

    visit 1 in acute phase; heart rate variability recording

    Time frame: 1 week

  6. effects of TEA on autonomic function

    visit 2 in acute phase; heart rate variability recording

    Time frame: 2 weeks

  7. effects of TEA on autonomic function

    visit 3 in acute phase; heart rate variability recording

    Time frame: 3 weeks

  8. effects of TEA on autonomic function

    visit 4 in acute phase; heart rate variability recording

    Time frame: 4 weeks

  9. effects of TEA on gastric motility

    visit 1 in chronic phase; gastric slow waves recording

    Time frame: 1 day

  10. effects of TEA on gastric motility

    visit 2 in chronic phase; gastric slow waves recording

    Time frame: 28 days

  11. effects of TEA on gastric motility

    visit 3 in chronic phase; gastric slow waves recording

    Time frame: 42 days

  12. effects of TEA on gastric motility

    visit 4 in chronic phase; gastric slow waves recording

    Time frame: 70 days

  13. effects of TEA on gastric motility

    visit 1 in chronic phase; breath test will be used to assess gastric emptying

    Time frame: 1 day

  14. effects of TEA on gastric motility

    visit 2 in chronic phase; breath test will be used to assess gastric emptying

    Time frame: 28 days

  15. effects of TEA on gastric motility

    visit 3 in chronic phase; breath test will be used to assess gastric emptying

    Time frame: 42 days

  16. effects of TEA on gastric motility

    visit 4 in chronic phase; breath test will be used to assess gastric emptying

    Time frame: 70 days

  17. effects of TEA on autonomic function

    visit 1 in chronic phase; heart rate variability recording

    Time frame: 1 day

  18. effects of TEA on autonomic function

    visit 2 in chronic phase; heart rate variability recording

    Time frame: 28 days

  19. effects of TEA on autonomic function

    visit 3 in chronic phase; heart rate variability recording

    Time frame: 42 days

  20. effects of TEA on autonomic function

    visit 4 in chronic phase; heart rate variability recording

    Time frame: 70 days

  21. effects of TEA on autonomic function

    visit 1 in chronic phase; Composite Autonomic Symptoms Score (COMPASS) 31 survey will be used to assess autonomic function

    Time frame: 1 day

  22. effects of TEA on autonomic function

    visit 2 in chronic phase; Composite Autonomic Symptoms Score (COMPASS) 31 survey will be used to assess autonomic function

    Time frame: 28 days

  23. effects of TEA on autonomic function

    visit 3 in chronic phase; Composite Autonomic Symptoms Score (COMPASS) 31 survey will be used to assess autonomic function

    Time frame: 42 days

  24. effects of TEA on autonomic function

    visit 1 in chronic phase; Composite Autonomic Symptoms Score (COMPASS) 31 survey visit 4 in chronic phase; will be used to assess autonomic function

    Time frame: 70 days

  25. effects of TEA on autonomic function

    baseline before the study; NE (indication of sympathetic activity) will be assessed using ELISA autonomic function.

    Time frame: 1 day

  26. effects of TEA on autonomic function

    baseline before the study; NE (indication of sympathetic activity) will be assessed using ELISA autonomic function.

    Time frame: 28 days

  27. effects of TEA on autonomic function

    baseline before the study; NE (indication of sympathetic activity) will be assessed using ELISA autonomic function.

    Time frame: 42 days

  28. effects of TEA on autonomic function

    baseline before the study; NE (indication of sympathetic activity) will be assessed using ELISA autonomic function.

    Time frame: 70 days

  29. effects of TEA on autonomic function

    30 minutes after the testing meal; NE (indication of sympathetic activity) will be assessed using ELISA autonomic function.

    Time frame: 1 day

  30. effects of TEA on autonomic function

    30 minutes after the testing meal; NE (indication of sympathetic activity) will be assessed using ELISA autonomic function.

    Time frame: 28 days

  31. effects of TEA on autonomic function

    30 minutes after the testing meal; NE (indication of sympathetic activity) will be assessed using ELISA autonomic function.

    Time frame: 42 days

  32. effects of TEA on autonomic function

    30 minutes after the testing meal; NE (indication of sympathetic activity) will be assessed using ELISA autonomic function.

    Time frame: 70 days

  33. effects of TEA on autonomic function

    60 minutes after the testing meal; NE (indication of sympathetic activity) will be assessed using ELISA autonomic function.

    Time frame: 1 day

  34. effects of TEA on autonomic function

    60 minutes after the testing meal; NE (indication of sympathetic activity) will be assessed using ELISA autonomic function.

    Time frame: 28 days

  35. effects of TEA on autonomic function

    60 minutes after the testing meal; NE (indication of sympathetic activity) will be assessed using ELISA autonomic function.

    Time frame: 42 days

  36. effects of TEA on autonomic function

    60 minutes after the testing meal; NE (indication of sympathetic activity) will be assessed using ELISA autonomic function.

    Time frame: 70 days

  37. effects of TEA on autonomic function

    baseline before the study; pancreatic polypeptide (PP, indication of vagal activity) will be assessed using ELISA autonomic function.

    Time frame: 1 day

  38. effects of TEA on autonomic function

    baseline before the study; pancreatic polypeptide (PP, indication of vagal activity) will be assessed using ELISA autonomic function.

    Time frame: 28 days

  39. effects of TEA on autonomic function

    baseline before the study; pancreatic polypeptide (PP, indication of vagal activity) will be assessed using ELISA autonomic function.

    Time frame: 42 days

  40. effects of TEA on autonomic function

    baseline before the study; pancreatic polypeptide (PP, indication of vagal activity) will be assessed using ELISA autonomic function.

    Time frame: 70 days

  41. effects of TEA on autonomic function

    30 minutes after the testing meal; pancreatic polypeptide (PP, indication of vagal activity) will be assessed using ELISA autonomic function.

    Time frame: 1 day

  42. effects of TEA on autonomic function

    30 minutes after the testing meal; pancreatic polypeptide (PP, indication of vagal activity) will be assessed using ELISA autonomic function.

    Time frame: 28 days

  43. effects of TEA on autonomic function

    30 minutes after the testing meal; pancreatic polypeptide (PP, indication of vagal activity) will be assessed using ELISA autonomic function.

    Time frame: 42 days

  44. effects of TEA on autonomic function

    30 minutes after the testing meal; pancreatic polypeptide (PP, indication of vagal activity) will be assessed using ELISA autonomic function.

    Time frame: 70 days

  45. effects of TEA on autonomic function

    60 minutes after the testing meal; pancreatic polypeptide (PP, indication of vagal activity) will be assessed using ELISA autonomic function.

    Time frame: 1 day

  46. effects of TEA on autonomic function

    60 minutes after the testing meal; pancreatic polypeptide (PP, indication of vagal activity) will be assessed using ELISA autonomic function.

    Time frame: 28 days

  47. effects of TEA on autonomic function

    60 minutes after the testing meal; pancreatic polypeptide (PP, indication of vagal activity) will be assessed using ELISA autonomic function.

    Time frame: 42 days

  48. effects of TEA on autonomic function

    60 minutes after the testing meal; pancreatic polypeptide (PP, indication of vagal activity) will be assessed using ELISA autonomic function.

    Time frame: 70 days

  49. effects of TEA on GI hormones and inflammatory cytokine

    baseline before the study; vasoactive intestinal peptide (VIP)

    Time frame: 1 day

  50. effects of TEA on GI hormones and inflammatory cytokine

    baseline before the study; vasoactive intestinal peptide (VIP)

    Time frame: 28 days

  51. effects of TEA on GI hormones and inflammatory cytokine

    baseline before the study; vasoactive intestinal peptide (VIP)

    Time frame: 42 days

  52. effects of TEA on GI hormones and inflammatory cytokine

    baseline before the study; vasoactive intestinal peptide (VIP)

    Time frame: 70 days

  53. effects of TEA on GI hormones and inflammatory cytokine

    30 minutes after the testing meal; vasoactive intestinal peptide (VIP)

    Time frame: 1 day

  54. effects of TEA on GI hormones and inflammatory cytokine

    30 minutes after the testing meal; vasoactive intestinal peptide (VIP)

    Time frame: 28 days

  55. effects of TEA on GI hormones and inflammatory cytokine

    30 minutes after the testing meal; vasoactive intestinal peptide (VIP)

    Time frame: 42 days

  56. effects of TEA on GI hormones and inflammatory cytokine

    30 minutes after the testing meal; vasoactive intestinal peptide (VIP)

    Time frame: 70 days

  57. effects of TEA on GI hormones and inflammatory cytokine

    60 minutes after the testing meal; vasoactive intestinal peptide (VIP)

    Time frame: 1 day

  58. effects of TEA on GI hormones and inflammatory cytokine

    60 minutes after the testing meal; vasoactive intestinal peptide (VIP)

    Time frame: 28 days

  59. effects of TEA on GI hormones and inflammatory cytokine

    60 minutes after the testing meal; vasoactive intestinal peptide (VIP)

    Time frame: 42 days

  60. effects of TEA on GI hormones and inflammatory cytokine

    60 minutes after the testing meal; vasoactive intestinal peptide (VIP)

    Time frame: 70 days

  61. effects of TEA on GI hormones and inflammatory cytokine

    baseline before the study; interleukin-10 (IL-10)

    Time frame: day 1

  62. effects of TEA on GI hormones and inflammatory cytokine

    baseline before the study; interleukin-10 (IL-10)

    Time frame: 28 days

  63. effects of TEA on GI hormones and inflammatory cytokine

    baseline before the study; interleukin-10 (IL-10)

    Time frame: 42 days

  64. effects of TEA on GI hormones and inflammatory cytokine

    baseline before the study; interleukin-10 (IL-10)

    Time frame: 70 days

  65. effects of TEA on GI hormones and inflammatory cytokine

    30 minutes after the testing meal; interleukin-10 (IL-10)

    Time frame: 1 day

  66. effects of TEA on GI hormones and inflammatory cytokine

    30 minutes after the testing meal; interleukin-10 (IL-10)

    Time frame: 28 days

  67. effects of TEA on GI hormones and inflammatory cytokine

    30 minutes after the testing meal; interleukin-10 (IL-10)

    Time frame: 42 days

  68. effects of TEA on GI hormones and inflammatory cytokine

    30 minutes after the testing meal; interleukin-10 (IL-10)

    Time frame: 70 days

  69. effects of TEA on GI hormones and inflammatory cytokine

    60 minutes after the testing meal; interleukin-10 (IL-10)

    Time frame: 1 day

  70. effects of TEA on GI hormones and inflammatory cytokine

    60 minutes after the testing meal; interleukin-10 (IL-10)

    Time frame: 28 days

  71. effects of TEA on GI hormones and inflammatory cytokine

    60 minutes after the testing meal; interleukin-10 (IL-10)

    Time frame: 42 days

  72. effects of TEA on GI hormones and inflammatory cytokine

    60 minutes after the testing meal; interleukin-10 (IL-10)

    Time frame: 70 days

  73. effects of TEA on GI hormones and inflammatory cytokine

    baseline before the study; interferon α(IFNα)

    Time frame: 1 day

  74. effects of TEA on GI hormones and inflammatory cytokine

    baseline before the study; interferon α(IFNα)

    Time frame: 28 days

  75. effects of TEA on GI hormones and inflammatory cytokine

    baseline before the study; interferon α(IFNα)

    Time frame: 42 days

  76. effects of TEA on GI hormones and inflammatory cytokine

    baseline before the study; interferon α(IFNα)

    Time frame: 70 days

  77. effects of TEA on GI hormones and inflammatory cytokine

    30 minutes after the testing meal; interferon α(IFNα)

    Time frame: 1 day

  78. effects of TEA on GI hormones and inflammatory cytokine

    30 minutes after the testing meal; interferon α(IFNα)

    Time frame: 28 days

  79. effects of TEA on GI hormones and inflammatory cytokine

    30 minutes after the testing meal; interferon α(IFNα)

    Time frame: 42 days

  80. effects of TEA on GI hormones and inflammatory cytokine

    30 minutes after the testing meal; interferon α(IFNα)

    Time frame: 70 days

  81. effects of TEA on GI hormones and inflammatory cytokine

    60 minutes after the testing meal; interferon α(IFNα)

    Time frame: 1 day

  82. effects of TEA on GI hormones and inflammatory cytokine

    60 minutes after the testing meal; interferon α(IFNα)

    Time frame: 28 days

  83. effects of TEA on GI hormones and inflammatory cytokine

    60 minutes after the testing meal; interferon α(IFNα)

    Time frame: 42 days

  84. effects of TEA on GI hormones and inflammatory cytokine

    60 minutes after the testing meal; interferon α(IFNα)

    Time frame: 70 days

  85. effects of TEA on GI hormones and inflammatory cytokine

    baseline before the study; interleukin-1 beta (IL-1β)

    Time frame: 1 day

  86. effects of TEA on GI hormones and inflammatory cytokine

    baseline before the study; interleukin-1 beta (IL-1β)

    Time frame: 28 days

  87. effects of TEA on GI hormones and inflammatory cytokine

    baseline before the study; interleukin-1 beta (IL-1β)

    Time frame: 42 days

  88. effects of TEA on GI hormones and inflammatory cytokine

    baseline before the study; interleukin-1 beta (IL-1β)

    Time frame: 70 days

  89. effects of TEA on GI hormones and inflammatory cytokine

    30 minutes after the testing meal; interleukin-1 beta (IL-1β)

    Time frame: 1 day

  90. effects of TEA on GI hormones and inflammatory cytokine

    30 minutes after the testing meal; interleukin-1 beta (IL-1β)

    Time frame: 28 days

  91. effects of TEA on GI hormones and inflammatory cytokine

    30 minutes after the testing meal; interleukin-1 beta (IL-1β)

    Time frame: 42 days

  92. effects of TEA on GI hormones and inflammatory cytokine

    30 minutes after the testing meal; interleukin-1 beta (IL-1β)

    Time frame: 70 days

  93. effects of TEA on GI hormones and inflammatory cytokine

    60 minutes after the testing meal; interleukin-1 beta (IL-1β)

    Time frame: 1 day

  94. effects of TEA on GI hormones and inflammatory cytokine

    60 minutes after the testing meal; interleukin-1 beta (IL-1β)

    Time frame: 28 days

  95. effects of TEA on GI hormones and inflammatory cytokine

    60 minutes after the testing meal; interleukin-1 beta (IL-1β)

    Time frame: 42 days

  96. effects of TEA on GI hormones and inflammatory cytokine

    60 minutes after the testing meal; interleukin-1 beta (IL-1β)

    Time frame: 70 days

  97. effects of TEA on GI hormones and inflammatory cytokine

    baseline before the study; interleukin-6 (IL-6)

    Time frame: 1 day

  98. effects of TEA on GI hormones and inflammatory cytokine

    baseline before the study; interleukin-6 (IL-6)

    Time frame: 28 days

  99. effects of TEA on GI hormones and inflammatory cytokine

    baseline before the study; interleukin-6 (IL-6)

    Time frame: 42 days

  100. effects of TEA on GI hormones and inflammatory cytokine

    baseline before the study; interleukin-6 (IL-6)

    Time frame: 70 days

  101. effects of TEA on GI hormones and inflammatory cytokine

    30 minutes after the testing meal; interleukin-6 (IL-6)

    Time frame: 1 day

  102. effects of TEA on GI hormones and inflammatory cytokine

    30 minutes after the testing meal; interleukin-6 (IL-6)

    Time frame: 28 days

  103. effects of TEA on GI hormones and inflammatory cytokine

    30 minutes after the testing meal; interleukin-6 (IL-6)

    Time frame: 42 days

  104. effects of TEA on GI hormones and inflammatory cytokine

    30 minutes after the testing meal; interleukin-6 (IL-6)

    Time frame: 70 days

  105. effects of TEA on GI hormones and inflammatory cytokine

    60 minutes after the testing meal; interleukin-6 (IL-6)

    Time frame: 1 day

  106. effects of TEA on GI hormones and inflammatory cytokine

    60 minutes after the testing meal; interleukin-6 (IL-6)

    Time frame: 28 days

  107. effects of TEA on GI hormones and inflammatory cytokine

    60 minutes after the testing meal; interleukin-6 (IL-6)

    Time frame: 42 days

  108. effects of TEA on GI hormones and inflammatory cytokine

    60 minutes after the testing meal; interleukin-6 (IL-6)

    Time frame: 70 days

  109. effects of TEA on GI hormones and inflammatory cytokine

    baseline before the study; tumor necrosis factor alpha(TNFα)

    Time frame: day 1

  110. effects of TEA on GI hormones and inflammatory cytokine

    baseline before the study; tumor necrosis factor alpha(TNFα)

    Time frame: 28 days

  111. effects of TEA on GI hormones and inflammatory cytokine

    baseline before the study; tumor necrosis factor alpha(TNFα)

    Time frame: 42 days

  112. effects of TEA on GI hormones and inflammatory cytokine

    baseline before the study; tumor necrosis factor alpha(TNFα)

    Time frame: 70 days

  113. effects of TEA on GI hormones and inflammatory cytokine

    30 minutes after the testing meal; tumor necrosis factor alpha(TNFα)

    Time frame: 1 day

  114. effects of TEA on GI hormones and inflammatory cytokine

    30 minutes after the testing meal; tumor necrosis factor alpha(TNFα)

    Time frame: 28 days

  115. effects of TEA on GI hormones and inflammatory cytokine

    30 minutes after the testing meal; tumor necrosis factor alpha(TNFα)

    Time frame: 42 days

  116. effects of TEA on GI hormones and inflammatory cytokine

    30 minutes after the testing meal; tumor necrosis factor alpha(TNFα)

    Time frame: 70 days

  117. effects of TEA on GI hormones and inflammatory cytokine

    60 minutes after the testing meal; tumor necrosis factor alpha(TNFα)

    Time frame: 1 day

  118. effects of TEA on GI hormones and inflammatory cytokine

    60 minutes after the testing meal; tumor necrosis factor alpha(TNFα)

    Time frame: 28 days

  119. effects of TEA on GI hormones and inflammatory cytokine

    60 minutes after the testing meal; tumor necrosis factor alpha(TNFα)

    Time frame: 42 days

  120. effects of TEA on GI hormones and inflammatory cytokine

    60 minutes after the testing meal; tumor necrosis factor alpha(TNFα)

    Time frame: 70 days

07

Study locations

1 site
  • Johns Hopkins Bayview Medical Center
    Baltimore, Maryland 21224, United States
08

References and documents

Individual participant data

Plan to share: Undecided — haven't decided yet.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Feb 2017 to primary completion in Jun 2019, 28 months.

Of 51 non-industry interventional studies with no phase under Scleroderma, Diffuse, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 27. This study's 28 months is above that.

Counting every sponsor, half of 53 studies reached it within 16 months; a quarter within 4 and three quarters within 28.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 18, 2017
First posted
Sep 27, 2017
StartActual
Feb 6, 2017
Primary completionActual
Jun 30, 2019
CompletionActual
Nov 20, 2019
Last update
Nov 26, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 26, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03294616
Responsible party
Sponsor
First posted
Sep 27, 2017
Start date
Feb 6, 2017
Primary completion
Jun 30, 2019
Completion
Nov 20, 2019
Last update
Nov 26, 2019

Study contacts

Jiande Chen, Ph.D
principal investigator · Johns Hopkins University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.

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Discussion

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