CClinicalTrials.gg
Sign In
Status unknownNCT03469232Updated Apr 10, 2018

Effectiveness and Clinical Mechanism of Huanglian-Jiedu Decoction in Patients With Intense-exuberant Stomach Fire Syndrome

A Phase 1/2 interventional study of Huanglian-Jiedu Decoction in Intense-exuberant Stomach Fire Syndrom, Acute Pericoronitis and Recurrent Aphthous Stomatitis, sponsored by China Academy of Chinese Medical Sciences. Status unknown at 3 sites in China. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2018-04-10.

Sponsored by China Academy of Chinese Medical Sciences · Phase 1/2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2018), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 1/2
Study type
Interventional
Enrollment
240
Allocation
Non-randomized
Ages
18 Years to 60 Years
Sex
All
01

Study summary

This clinical research focus on evaluating the effectiveness of Huanglian-Jiedu Decoction in patients with intense-exuberant stomach fire syndrome (one of the common TCM syndrome)of acute pericoronitis,minor recurrent aphthous stomatitis and recurrent herpes simplex labialis,meanwhile, exploring the pharmacological mechanism and potential biomarkers of this traditional formula.

Read the detailed description

Huanglian-Jiedu Decoction, as a traditional Chinese medicine formula，includes 4 kinds of Chinese herbs as following: Huanglian (Rhizoma Coptidis), Huangbo (Cortex Phellodendri), Huangqin (Scutellaria baicalensis) and Zhizi (Scutellaria baicalensis). Huanglian-Jiedu Decoction has been recorded to be effective in many diseases that belong to the syndrome of intense-exuberant stomach fire from thousands years of clinical practice, just like acute pericoronitis, minor recurrent aphthous stomatitis and recurrent herpes simplex labialis,etc. While its clinical pharmacological mechanism has not been clearly illustrated. In this study, the investigators focus on evaluating the effectiveness of Huanglian-Jiedu Decoction in patients with intense-exuberant stomach fire syndrome (including three disease: acute pericoronitis, minor recurrent aphthous stomatitis and recurrent herpes simplex labialis), and exploring the pharmacological mechanism and potential biomarkers of this traditional formula.

02

Conditions studied

  • Intense-exuberant Stomach Fire Syndrom
  • Acute Pericoronitis
  • Recurrent Aphthous Stomatitis
  • Recurrent Herpes Simplex Labialis
03

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • General inclusion criteria:

    1. Female or male patients.
    2. Age: 18 - 60 years.
    3. Meeting the diagnostic criteria of Intense-Exuberant Stomach Fire Syndrome according to the traditional Chinese medicine.
    4. Patient is willing to participate voluntarily and to sign a written patient informed consent.

  • Disease-specific inclusion criteria for patients with acute pericoronitis:

    1. Patients with clinical diagnosis of acute pericoronitis and without treatment before the study began.

  • Disease-specific inclusion criteria for patients with minor recurrent aphthous stomatitis:

    1. Patients with clinical diagnosis of minor recurrent aphthous stomatitis(MiRAS).
    2. A history of MiRAS for more than 6 months and an expectation that the ulcers normally take 5 or more days to resolve without treatment.
    3. Ulcer occurred less than 48h hours' duration without treatment.

  • Disease-specific inclusion criteria for recurrent herpes simplex labialis

    1. Patients with clinical diagnosis of recurrent herpes simplex labialis.
    2. History of recurrent herpes labialis averaging 1 or more episodes per year.
    3. Onset of prodrome, erythema or vesicle within 48 hours without treatment.

Exclusion criteria

Exclusion Criteria:

  • General exclusion criteria:

    1. Patients with severe cardiac dysfunction on the grade of heart function over Ⅲ grade and/or liver function impairment with the value of ALT over 1.5-fold of normal value and/or renal dysfunction with the value over 133μmol/L.
    2. Patients who have serious, unstable, or clinically significant medical or psychological conditions, which, in the opinion of the investigator(s), would compromise the subject's participation in the study (including but not limited to arrhythmia, uncontrolled hypertension, diabetes, hepatitis, kidney failure, AIDS, cancer, etc.
    3. Women during pregnancy, lactation , breastfeeding or having child bearing potential without use an adequate method of birth control.
    4. Patients who known allergy to the study drug or the Huanglian (Rhizoma Coptidis), Huangbo (Cortex Phellodendri), Huangqin (Scutellaria baicalensis) and Zhizi (Scutellaria baicalensis ( Patients who are insufficiency of the spleen-yang according to the TCM should be exclude ).
    5. Patients participating in or having participated in other clinical studies in the 3 months prior to this clinical trial.
    6. Patients who are considered unreliable as to medication compliance or adherence to scheduled appointments.

  • Disease-specific exclusion criteria for acute pericoronitis:

    1. Patients who smoked at least 20 cigarettes per day（heavy smokers）.
    2. Patients with fascial space infection of maxillofacial region or/and chronic periodontitis.
    3. Patients with periodontal disease in the region of the acute pericoronitis.
    4. Patients who had systemic administration of antibiotics within the past 4 weeks

  • Disease-specific exclusion criteria for minor recurrent aphthous stomatitis(MiRAS):

    1. Patients with history of drug abuse within the past 6 months.
    2. Patients who smoked at least 20 cigarettes per day（heavy smokers）.
    3. Patients with ulcers as a manifestation of a systemic disease process such as ulcerative colitis, Behcet's syndrome, Reiter' s syndrome or immune deficiency.
    4. Patients who had systemic administration of antibiotics within the past 4 weeks or/ and had treatment with systemic steroid or immunomodulatory within 3 month before the study entry.
    5. Patients who had orthodontic braces or retainer that might contact with the ulcer.

  • Disease-specific exclusion criteria for recurrent herpes simplex labialis:

    1. Patients with fever > 38.5℃, and / or blood WBC>11.0x109/L, and / or neutrophil >85%.
    2. Patients who had systemic administration of antibiotics within the past 4 weeks or/ and had treatment with immunomodulatory within 3 month before the study entry.
04

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
240 participants (estimated)

Study arms

  • Experimental
    Huanglian-Jiedu Decoction in acute pericoronitis

    All eligible patients entering this group will receive Huanglian-Jiedu Decoction(prepared as granule). 1 bag per time and twice a day for 5 days.

    Drug: Huanglian-Jiedu Decoction

  • Experimental
    Huanglian-Jiedu Decoction in recurrent aphthous stomatitis

    All eligible patients entering this group will receive Huanglian-Jiedu Decoction(prepared as granule). 1 bag per time and twice a day for 5 days.

    Drug: Huanglian-Jiedu Decoction

  • Experimental
    Huanglian-Jiedu Decoction in recurrent herpes simplex labialis

    All eligible patients entering this group will receive Huanglian-Jiedu Decoction(prepared as granule). 1 bag per time and twice a day for 5 days.

    Drug: Huanglian-Jiedu Decoction

Interventions

  • DrugHuanglian-Jiedu Decoction

    Huanglian-Jiedu Decoction includes 4 kinds of Chinese herbs as following: Huanglian (Rhizoma Coptidis), Huangbo (Cortex Phellodendri), Huangqin (Scutellaria baicalensis) and Zhizi (Scutellaria baicalensis). All of them were prepared as granule.

05

What researchers measure

Primary outcomes

  1. Change from baseline in the Intense-Exuberant Stomach Fire Syndrome scores

    Intense-Exuberant Stomach Fire Syndrome scores were questionnaires that consists of basic symptoms and disease-specific symptoms that described in traditional Chinese medicine. The basic symptoms included feverish sensation, thirst that preferring cold drink, bad breath, flushed face, bound stool, scanty yellowish urine, red tongue with dry and yellowish fur, and the forceful or rapid pulse. The disease-specific symptoms included tooth or/and gums for acute pericoronitis, ulcer for recurrent aphthous stomatitis and herpes for recurrent herpes simplex labialis. Each symptom was assessed by the Visual Analogue Scale（VAS），where a higher score meant higher severity.

    Time frame: Day 0,Day 3,Day 5

Secondary outcomes

  1. Change from baseline of each symptom in Intense-Exuberant Stomach Fire Syndrome scores

    Time frame: Day 0,Day 3,Day 5

  2. The proportion of patients whose Intense-Exuberant Stomach Fire Syndrome were disappeared

    The definition of "disappeared" is the scores of all the symptoms in Intense-Exuberant Stomach Fire Syndrome were 0 or the reduction in rate of Intense-Exuberant Stomach Fire Syndrome scores more than 90%

    Time frame: Day 0,Day 5

  3. The proportion of patients who gain 50% reduction of Intense-Exuberant Stomach Fire Syndrome scores

    Reduction in rate of Intense-Exuberant Stomach Fire Syndrome scores =（The score of Intense-Exuberant Stomach Fire Syndrome before treatment - the score of Intense-Exuberant Stomach Fire Syndrome after treatment）/ The score of Intense-Exuberant Stomach Fire Syndrome before treatment×100%.

    Time frame: Day 0,Day 5

  4. Change from baseline on toothache based on visual analogue scale(VAS)for acute pericoronitis

    Patients were asked to record the VAS each morning for 5 consecutive days prior to taking their medication.

    Time frame: Day 0,Day 1,Day 2,Day 3,Day 4,Day 5

  5. Change from baseline on maximum mouth opening (MMO) for acute pericoronitis

    To measure the amount of MMO, the inter-incisal distance between maxillary and mandibular right central incisors was recorded using a caliper.

    Time frame: Day 0,Day 3,Day 5

  6. Number of patients with trismu for acute pericoronitis

    Patients were recorded to have trismus if the MMO was less than 40 mm.

    Time frame: Day 0,Day 3,Day 5

  7. Change from baseline on OHIP-14 measures for acute pericoronitis

    Using the OHIP measures, the patients were asked to rate the impact of their oral health on 14 key areas of OHRQoL: "What effects do your teeth, gums, and/or mouth have on each of the 14 key areas of life quality (i.e., your comfort, your speech)?" These 14 items were subdivided into seven domains (subscales): functional limitation, physical discomfort, psychological discomfort, physical disability, psychological disability, social disability, and handicap. For the OHIP-14, the response categories were recorded on a five-point Likert scale: 0, never; 1, hardly ever; 2, occasionally; 3, fairly often; 4, very often. Higher scores in the OHIP-14 questionnaire indicated a poorer OHQoL.

    Time frame: Day 0,Day 3,Day 5

  8. Change from baseline of VAS on the pain of ulcer for minor recurrent aphthous stomatitis

    Patients were asked to record the VAS each morning for 5 consecutive days prior to taking their medication.

    Time frame: Day 0,Day 1,Day 2,Day 3,Day 4,Day 5

  9. The proportion of patients with ulcer healing for minor recurrent aphthous stomatitis

    Time frame: Day 0,Day 3,Day 5

  10. The sizes of ulcer for minor recurrent aphthous stomatitis

    The investigators chose one of the largest ulcer and measured the maximum diameters and its vertical using a calibrated dental probe with millimeter markings. The two measurements were then multiplied to represent the size of the ulcer.

    Time frame: Day 0,Day 3,Day 5

  11. The number of days that the lesion was present (until loss of crust)for recurrent herpes simplex labialis

    Time frame: From the date of lesion or premonitory symptom present until the date of crust lose, which up to 28 days.

  12. The proportion of patients with lesion healing for recurrent herpes simplex labialis

    Time frame: Day 3,Day 5

  13. Change from baseline of VAS on the pain of lesions for recurrent herpes simplex labialis

    Patients were asked to record the VAS each morning for 5 consecutive days prior to taking their medication.

    Time frame: Day 0,Day 1,Day 2,Day 3,Day 4,Day 5

Other outcomes

  1. High-sensitivity C-reactive protein（hs-CRP）

    Time frame: Day 0,Day 5

  2. Evaluation of inflammatory cytokines

    The evaluation of inflammatory cytokines include IL-1α, IL-1β, IL-4, IL-6, IL-8, IL-10, IL-13, MIP-2, MCP-1, IFNγand TNF-α

    Time frame: Day 0,Day 5

  3. Activity of sirtuins (SIRTs)

    Detection by qRT-PCR

    Time frame: Day 0,Day 5

  4. GSH/GSSG ratios in plasma

    Time frame: Day 0,Day 5

  5. Evaluation of oxidative stress parameters：SOD

    Time frame: Day 0,Day 5

  6. Evaluation of oxidative stress parameters：MDA

    Time frame: Day 0,Day 5

  7. Pyruvate Acid / Uric Acid ratios in plasma

    Time frame: Day 0,Day 5

  8. Mass Spectrometry analyses for urine sample

    Mass Spectrometry analyses for urine sample include hypoxanthine, 1.7 - diphosphate sedoheptose, -5- riboflavin phosphate, urobilin, D - Ribose, ubiquinone, urinary lactate / pyruvate urine

    Time frame: Day 0,Day 5

  9. Proteomic analyses for blood sample

    Time frame: Day 0,Day 5

  10. Proteomic analyses for urine sample

    Time frame: Day 0,Day 5

06

Study locations

3 of 3 sites recruiting
  • Third affiliated hospital of Beijing University of traditional Chinese medicine
    Beijing, Beijing 100029, China
    • Lu Qiang, Professor · Contact · 8610-52075325
    • Lu Qiang, Professor · Principal investigator
    Recruiting
  • Dongfang Hospital Affiliated to Beijing University of traditional Chinese medicine
    Beijing, Beijing 100078, China
    • Hong Mu, Professor · Contact · 010-67618333
    • Hong Mu, Professor · Principal investigator
    Recruiting
  • Affiliated Hospital to Chengdu University of traditional Chinese medicine
    Chengdu, Sichuan 610075, China
    • Yuling Zuo, Professor · Contact · 028-87769902
    • Yuling Zuo, Professor · Principal investigator
    Recruiting
07

Registry details

Key details

Study ID
NCT03469232
Lead sponsor
China Academy of Chinese Medical Sciences
Responsible party
Zhong Wang (Chief, China Academy of Chinese Medical Sciences) — Principal investigator
First posted
Mar 19, 2018
Start date
Apr 4, 2018
Primary completion
Sep 1, 2018 (estimated)
Completion
Nov 1, 2018 (estimated)
Last update
Apr 10, 2018

Study contacts

Yanan Yu, Ph.D
Contact
pumpkinnaicha@163.com
8610-64093140
Zhong Wang, Professor
Contact
zhonw@vip.sina.com
8610-64093140
Zhong Wang
principal investigator · Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences

Oversight

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

Not currently enrolling

This study is status unknown, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Herpes Simplex→

Other studies from this sponsor

China Academy of Chinese Medical Sciences

Start the discussion