An interventional study of Thread embedding acupuncture and Sham thread embedding acupuncture in Obesity and Overweight, sponsored by Beijing Hospital of Traditional Chinese Medicine. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-01-16.
Sponsored by Beijing Hospital of Traditional Chinese Medicine · Not applicable, Interventional, and Treatment
Obesity is the most prevalent chronic disease worldwide, affecting approximately 800 million adults. Excess adiposity and its numerous complications, including cardiovascular disease and type 2 diabetes, impose a considerable economic burden and constitute major contributors to global morbidity and mortality. Treatments that result in substantial weight reductions may improve outcomes for people living with obesity. Thread embedding acupuncture which provides long-term acupoints stimulation may be an effective treatment option for obesity. However, effects of thread embedding on obesity remain uncertain because of the small sample sizes or other methodological limitations. The objective of this multi-center, randomized, sham-controlled trial is to assess the effect of thread embedding acupuncture for alleviating weight.
The present multi-center, randomized, sham-controlled, parallel-group trial aims to evaluate the effect of thread embedding acupuncture in patients with obesity.
The patients will be randomized to receive one of two treatment arms: thread embedding acupuncture and sham thread embedding acupuncture. The participants will receive treatment that consists of 18 thread embedding acupuncture or sham thread embedding acupuncture sessions over a 24-week period after baseline (once a week for the first 12 weeks and every two weeks for the next 12 weeks). At the end of 24 weeks treatment, the change of weight in overweight/obese participants between the two groups will be analyzed.
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
This study's planned enrollment of 400 is above the median of 67 across 9,006 interventional studies indexed under Obesity.
Browse Obesity studies →Beijing Hospital of Traditional Chinese Medicine is the lead sponsor of 22 studies on the registry; 12 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
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.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
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.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The participants in the thread embedding acupuncture therapy group will receive treatment that consists of 18 thread embedding acupuncture sessions over a 24-week period after baseline (once a week for the first 12 weeks and every two weeks for the next 12 weeks).
Other: Thread embedding acupuncture
The participants in the sham thread embedding acupuncture therapy group will receive treatment that consists of 18 sham thread embedding acupuncture sessions over a 24-week period after baseline (once a week for the first 12 weeks and every two weeks for the next 12 weeks).
Other: Sham thread embedding acupuncture
Thread embedding acupuncture is performed using polyglycolic acido thread. Needles have a gauge size of 23G, a shaft length of 60mm, and a thread length of 50mm, folded in half, and are applied to fourteen acupoints, including Zhongwan (CV12), Qihai (CV6), bilateral Tianshu (ST 25), bilateral Wailing (ST 26), bilateral Daheng (SP 15), bilateral Zusanli (ST 36), bilateral Pishu (BL 20), and bilateral Weishu (BL 21). After the thread is inserted into the body, the needle will be withdrawn immediately. During the treatment period, health counseling will be provided by qualified staff at every visit, including diet and physical activity, but there will be no strict restrictions.
The protocol includes the same duration and frequency of sessions as for thread embedding acupuncture, but the treatment will be delivered superficially at non-acupuncture points 10mm from the lateral of the corresponding acupuncture and not above a meridian line. Needles without threads have a gauge size of 23G, and a shaft length of 60mm will be used. After the needle is inserted into the body, it will be withdrawn immediately. During the treatment period, health counseling will be provided by qualified staff at every visit, including diet and physical activity, but there will be no strict restrictions.
Relative change in body weight
Measured in percentage (%)
Time frame: From baseline (week 0) to end of treatment (week 24)
Body weight reduction greater than or equal to 5%
Measured as the percentage of participants
Time frame: From baseline (week 0) to end of treatment (week 24)
Body weight reduction greater than or equal to 10%
Measured as the percentage of participants
Time frame: From baseline (week 0) to end of treatment (week 24)
Change in body weight
Measured in kilogram (kg)
Time frame: From baseline (week 0) to end of treatment (week 24)
Change in Body Mass Index (BMI)
Measured in kilogram per square meter (kg/m\^2)
Time frame: From baseline (week 0) to end of treatment (week 24)
Change in body fat rate
Measured in percentage points
Time frame: From baseline (week 0) to end of treatment (week 24)
Change in waist circumference
Measured in centimeter (cm)
Time frame: From baseline (week 0) to end of treatment (week 24)
Change in waist-to-hip ratio
Calculated by dividing the waist circumference(cm) by the hip circumference(cm).
Time frame: From baseline (week 0) to end of treatment (week 24)
Change in Systolic Blood Pressure (SBP)
Measured in millimeter of mercury (mmHg)
Time frame: From baseline (week 0) to end of treatment (week 24)
Change in Diastolic Blood Pressure (DBP)
Measured in mmHg
Time frame: From baseline (week 0) to end of treatment (week 24)
Change in Glycated Haemoglobin (HbA1c)
Measured in percentage points
Time frame: From baseline (week 0) to end of treatment (week 24)
Change in Fasting Plasma Glucose (FPG)
Measured as millimole per liter (mmol/L)
Time frame: From baseline (week 0) to end of treatment (week 24)
Change in fasting serum insulin
Measured as milli-international units per milliliter (mIU/mL)\]
Time frame: From baseline (week 0) to end of treatment (week 24)
Change in high-density lipoprotein (HDL) cholesterol
Measured as mmol/L
Time frame: From baseline (week 0) to end of treatment (week 24)
Change in low-density lipoprotein (LDL) cholesterol
Measured as mmol/L
Time frame: From baseline (week 0) to end of treatment (week 24)
Change in triglycerides
Measured as mmol/L
Time frame: From baseline (week 0) to end of treatment (week 24)
Change in total cholesterol
Measured as mmol/L
Time frame: From baseline (week 0) to end of treatment (week 24)
Change in Short Form-36 (SF- 36) Physical Functioning score
The SF-36 is a 36-item commonly used generic clinical outcome assessment instrument measuring health-related quality of life and general health status across disease areas. SF-36 questionnaire measures 8 domains of functional health and well-being as well as 2 component summary scores (physical component summary and mental component summary). This endpoint assesses the physical functioning domain.
Time frame: From baseline (week 0) to end of treatment (week 24)
Change in SF-36: Physical Component Summary Score
The SF-36 is a 36-item commonly used generic clinical outcome assessment instrument measuring health-related quality of life and general health status across disease areas. SF-36 questionnaire measures 8 domains of functional health and well-being as well as 2 component summary scores (physical component summary and mental component summary).This endpoint assesses the physical component summary.
Time frame: From baseline (week 0) to end of treatment (week 24)
Change in SF-36: Mental Component Summary score
The SF-36 is a 36-item commonly used generic clinical outcome assessment instrument measuring health-related quality of life and general health status across disease areas. SF-36 questionnaire measures 8 domains of functional health and well-being as well as 2 component summary scores (physical component summary and mental component summary). This endpoint assesses the mental component summary.
Time frame: From baseline (week 0) to end of treatment (week 24)
Plan to share: No
No publications or documents are linked to this record.
Started Nov 2024 (actual). Primary completion is estimated for Oct 2026, 23 months after the start.
Of 3,680 non-industry interventional studies with no phase under Obesity, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 43. This study's planned 23 months is close to that.
Counting every sponsor, half of 3,843 studies reached it within 22 months; a quarter within 10 and three quarters within 42.
How these figures are worked out, and which studies are left out of them.
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Beijing Hospital of Traditional Chinese Medicine