Obesity and OverweightiShoNCT06653530
Thread Embedding Acupuncture Therapy for Weight Loss
A study testing Thread embedding acupuncture in people with Obesity and Overweight, run by Beijing Hospital of Traditional Chinese Medicine at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Obesity and Overweight
- What is being tested?
- Thread embedding acupuncture
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2024to 31 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Body-mass index: a. BMI ≥ 28 kg/m2 or b. BMI ≥ 24 kg/m2 with the presence of at least one of the following weight-related complications (treated or untreated): diabetes, hypertension, lipid metabolism disorders, obstructive sleep apnea, cardiovascular disease, knee osteoarthritis, hyperuricemia, fatty liver;
- Male or female, age between 18 and 75 years at the time of signing informed consent;
- No history of receiving thread embedding treatment;
- History of at least one self-reported unsuccessful dietary effort and exercise program to lose body weight;
- Informed consent obtained.
Who cannot join
- A self-reported change in body weight ≥ 5 kg within 90 days before screening;
- Treatment with any medication for the indication of obesity within the past 90 days before Screening;
- Previous or planned (during the trial period) obesity treatment with surgery or a bodyweight loss device. However, the following were allowed: (1) liposuction and/or abdominoplasty, if performed more than 1 year before screening; (2) lap banding, if the band had been removed more than 1 year before screening; (3) intragastric balloon, if the balloon had been removed more than 1 year before screening; or (4) duodenal-jejunal bypass sleeve, if the sleeve had been removed more than 1 year before screening;
- Have obesity induced by other endocrinologic disorders (for example, Cushing Syndrome) or diagnosed monogenetic or syndromic forms of obesity (for example, Melanocortin 4 Receptor deficiency or Prader Willi Syndrome);
- Uncontrolled thyroid disease, defined as thyroid stimulating hormone (TSH)>6.0 mIU/L or <0.35 mIU/L as measured by the central laboratory at screening;
- Diagnosed with type 2 diabetes mellitus ≤180 days prior to the day of screening or those who have taken treatment with oral agents that were unstable (different drug(s), dose, or dosing frequency) within the 90 days prior to screening;
Show all 18Show fewer
- Receipt of any acupuncture treatment for obesity within 90 days before screening;
- Participation in any structured, monitored weight-loss program within 90 days before screening;
- Active inflammatory bowel disease, celiac disease, chronic pancreatitis, or other disorder potentially causing malabsorption;
- Any of the following severe cardiovascular diseases: myocardial infarction, stroke, heart failure, symptomatic peripheral vascular diseases, or hospitalization for unstable angina or transient ischemic attack within the last 6 months prior to screening;
- History of malignant neoplasms within the past 5 years prior to screening. Basal and squamous cell skin cancer and any carcinoma in-situ are allowed;
- Chronic respiratory, neurological, musculoskeletal or other disorders where, in the judgement of the investigator, participants would have unacceptable risk or difficulty in complying with the protocol;
- Surgery scheduled for the duration of the trial, except for minor surgical procedures, in the opinion of the investigator;
- Known or suspected abuse of alcohol or recreational drugs;
- Female who was pregnant, breast-feeding, or intended to become pregnant, or was of child-bearing potential and not using a highly effective contraceptive method;
- Known or suspected hypersensitivity to trial product or related products;
- Participation in another clinical trial within 90 days before screening;
- Any disorder, unwillingness, or inability, not covered by any of the other exclusion criteria, which in the investigator's opinion might have jeopardised the participant's safety or compliance with the protocol.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Hospital of Traditional Chinese Medicine
Beijing, Beijing Municipality, 100010
Bin Li, MD, 0086-18910781852, libin@bjzhongyi.com
About this study
Official title: Efficacy and Safety of Thread Embedding Acupuncture Therapy for Weight Loss in Adults with Overweight or Obesity
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.
Read the detailed description
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.
- Conditions
- Obesity and Overweight
- Being tested
- Thread embedding acupuncture, Sham thread embedding acupuncture
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thread embedding acupunctureOther
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.
Sham thread embedding acupunctureOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Thread embedding acupuncture | Experimental | 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). Receives: Other: Thread embedding acupuncture |
| Sham thread embedding acupuncture | Sham comparator | 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). Receives: Other: Sham thread embedding acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative change in body weight
Measured in percentage (%)
Measured: From baseline (week 0) to end of treatment (week 24)
Secondary outcomes (19)
Body weight reduction greater than or equal to 5%
Measured as the percentage of participants
Measured: 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
Measured: From baseline (week 0) to end of treatment (week 24)
Change in body weight
Measured in kilogram (kg)
Measured: 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)
Measured: From baseline (week 0) to end of treatment (week 24)
Change in body fat rate
Measured in percentage points
Measured: From baseline (week 0) to end of treatment (week 24)
Change in waist circumference
Measured in centimeter (cm)
Measured: 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).
Measured: From baseline (week 0) to end of treatment (week 24)
Change in Systolic Blood Pressure (SBP)
Measured in millimeter of mercury (mmHg)
Measured: From baseline (week 0) to end of treatment (week 24)
Change in Diastolic Blood Pressure (DBP)
Measured in mmHg
Measured: From baseline (week 0) to end of treatment (week 24)
Change in Glycated Haemoglobin (HbA1c)
Measured in percentage points
Measured: From baseline (week 0) to end of treatment (week 24)
Change in Fasting Plasma Glucose (FPG)
Measured as millimole per liter (mmol/L)
Measured: From baseline (week 0) to end of treatment (week 24)
Change in fasting serum insulin
Measured as milli-international units per milliliter (mIU/mL)]
Measured: From baseline (week 0) to end of treatment (week 24)
Change in high-density lipoprotein (HDL) cholesterol
Measured as mmol/L
Measured: From baseline (week 0) to end of treatment (week 24)
Change in low-density lipoprotein (LDL) cholesterol
Measured as mmol/L
Measured: From baseline (week 0) to end of treatment (week 24)
Change in triglycerides
Measured as mmol/L
Measured: From baseline (week 0) to end of treatment (week 24)
Change in total cholesterol
Measured as mmol/L
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From baseline (week 0) to end of treatment (week 24)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2024
- Study start1 Nov 2024
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity and OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Hospital of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li bin, Beijing Hospital of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06653530
- Sponsor's protocol ID
- 2024BL02-055-02
- Acronym
- iSho
- Status last verified
- Oct 2024
- First submitted
- 21 Oct 2024
- Last updated
- 16 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Thread Embedding Acupuncture Therapy for Weight Loss in Adults with Overweight or Obesity
- ClinicalTrials.gov ID
- NCT06653530
- Acronym / sponsor ID
- iSho / 2024BL02-055-02
- Conditions
- Obesity and Overweight
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Beijing Hospital of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 22 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thread embedding acupuncture | Experimental | Other: Thread embedding acupunctureThe 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). |
| Sham thread embedding acupuncture | Sham comparator | Other: Sham thread embedding acupunctureThe 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). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Body-mass index: a. BMI ≥ 28 kg/m2 or b. BMI ≥ 24 kg/m2 with the presence of at least one of the following weight-related complications (treated or untreated): diabetes, hypertension, lipid metabolism disorders, obstructive sleep apnea, cardiovascular disease, knee osteoarthritis, hyperuricemia, fatty liver;
- Male or female, age between 18 and 75 years at the time of signing informed consent;
- No history of receiving thread embedding treatment;
- History of at least one self-reported unsuccessful dietary effort and exercise program to lose body weight;
- Informed consent obtained.
Key exclusion criteria (18 listed)
- A self-reported change in body weight ≥ 5 kg within 90 days before screening;
- Treatment with any medication for the indication of obesity within the past 90 days before Screening;
- Previous or planned (during the trial period) obesity treatment with surgery or a bodyweight loss device. However, the following were allowed: (1) liposuction and/or abdominoplasty, if performed more than 1 year before screening; (2) lap banding, if the band had been removed more than 1 year before screening; (3) intragastric balloon, if the balloon had been removed more than 1 year before screening; or (4) duodenal-jejunal bypass sleeve, if the sleeve had been removed more than 1 year before screening;
- Have obesity induced by other endocrinologic disorders (for example, Cushing Syndrome) or diagnosed monogenetic or syndromic forms of obesity (for example, Melanocortin 4 Receptor deficiency or Prader Willi Syndrome);
- Uncontrolled thyroid disease, defined as thyroid stimulating hormone (TSH)>6.0 mIU/L or <0.35 mIU/L as measured by the central laboratory at screening;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thread embedding acupunctureThread 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. | Other | Thread embedding acupuncture |
| Sham thread embedding acupunctureThe 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. | Other | Sham thread embedding acupuncture |
Primary outcome
Relative change in body weight
Time frame: From baseline (week 0) to end of treatment (week 24)
Measured in percentage (%)
19 secondary outcomes
Body weight reduction greater than or equal to 5%
Time frame: From baseline (week 0) to end of treatment (week 24)
Body weight reduction greater than or equal to 10%
Time frame: From baseline (week 0) to end of treatment (week 24)
Change in body weight
Time frame: From baseline (week 0) to end of treatment (week 24)
Change in Body Mass Index (BMI)
Time frame: From baseline (week 0) to end of treatment (week 24)
Change in body fat rate
Time frame: From baseline (week 0) to end of treatment (week 24)
Change in waist circumference
Time frame: From baseline (week 0) to end of treatment (week 24)
Change in waist-to-hip ratio
Time frame: From baseline (week 0) to end of treatment (week 24)
Change in Systolic Blood Pressure (SBP)
Time frame: From baseline (week 0) to end of treatment (week 24)
Change in Diastolic Blood Pressure (DBP)
Time frame: From baseline (week 0) to end of treatment (week 24)
Change in Glycated Haemoglobin (HbA1c)
Time frame: From baseline (week 0) to end of treatment (week 24)
Change in Fasting Plasma Glucose (FPG)
Time frame: From baseline (week 0) to end of treatment (week 24)
Change in fasting serum insulin
Time frame: From baseline (week 0) to end of treatment (week 24)
Change in high-density lipoprotein (HDL) cholesterol
Time frame: From baseline (week 0) to end of treatment (week 24)
Change in low-density lipoprotein (LDL) cholesterol
Time frame: From baseline (week 0) to end of treatment (week 24)
Change in triglycerides
Time frame: From baseline (week 0) to end of treatment (week 24)
Change in total cholesterol
Time frame: From baseline (week 0) to end of treatment (week 24)
Change in Short Form-36 (SF- 36) Physical Functioning score
Time frame: From baseline (week 0) to end of treatment (week 24)
Change in SF-36: Physical Component Summary Score
Time frame: From baseline (week 0) to end of treatment (week 24)
Change in SF-36: Mental Component Summary score
Time frame: From baseline (week 0) to end of treatment (week 24)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thread embedding acupuncture in people with Obesity and Overweight, run by Beijing Hospital of Traditional Chinese Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bin Li, Dr (0086-18910781852, libin@bjzhongyi.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relative change in body weight (time frame: From baseline (week 0) to end of treatment (week 24)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2025.