Obesity, AbdominalNCT04957134

Efficacy of Electro-acupuncture for Abdominal Obesity: Study for a Randomized Controlled Trial

A study testing Electro-acupuncture in people with Obesity, Abdominal, run by Hubei Hospital of Traditional Chinese Medicine at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Obesity, Abdominal
What is being tested?: Electro-acupuncture
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 66 participants
Where: 1 siteChina
Study dates: 22 Jul 2021to 15 Mar 2023
Phase: Interventional
Are there results?: None posted in the registry

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 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Patients recruited for this study should meet the following inclusion criteria:
1.Satisfying the criteria for the diagnosis of abdominal obesity; 2.18 years old≤age≤55 years old; 3.Being able to fully understand and voluntarily sign informed consent.

Who cannot join

Patients with any of the following criteria will be excluded from the study:
Presence of endocrine disorders such as: polycystic ovary syndrome; Cushing's syndrome; uncorrected thyroid disease.
Presence of diabetes mellitus, or hypertension, or abnormal liver and kidney functions, or mental diseases.
Pregnant or lactating state, women who plan to become pregnant within 12 weeks.
History of bulimia, anorexia, or any other eating disorders.
Use of medications in the past 3 months, such as diet drugs, corticosteroids, antidepressants, which may affect weight or appetite.

Show all 10Show fewer

History of surgical weight loss, postoperative adhesions.
History of participating in a clinical study of weight loss or any other therapies to lose weight in the past 3 months.
Unable to cooperate with the research caused by other diseases or reasons.
Received acupuncture within 6 months before enrollment

Trial locations and contacts

1 site in 1 country.

China1 site

Hubei Provincial Hospital of Traditional Chinese Medicine
Wuhan, Hubei, 430061

Other trials in China

About this study

Official title: The Efficacy and Safety of Electro-acupuncture for Abdominal Obesity: Original Study for a Multicenter, Randomized, Sham-controlled Trial

Electro-acupuncture provides stimulation to acupoints, and has been widely used to treat abdominal obesity in China despite of lack of high-level evidence for treatment efficacy. The study will investigate whether the electroacupuncture can alleviate clinical symptoms and the mechanism of action in patients with abdominal obesity.

Read the detailed description

The study will be a randomized controlled trial from May 2021 to December 2022, including 68 participants with abdominal obesity. The participants will be randomly divided into 2 groups in a 1:1 allocation ratio.The intervention group will receive electroacupuncture; the control group will receive sham acupuncture. Each treatment will last 12 weeks, including 8 weeks of intervention period and 24 weeks of follow-up. The primary outcome is the waist circumference (WC), the secondary outcomes include weight, body mass index (BMI), hipline, waist-hip-ratio (WHR), Insulin resistance index (IRI), blood fat, metabolomics will be used analysis the mechanism. The adverse events will be recorded during the intervention and follow-up period.

Conditions: Obesity, Abdominal
Being tested: Electro-acupuncture, Sham electro-acupuncture
Keywords: Abdominal obesity, Electro-acupuncture, Randomized controlled trial
Medical subject headings: Obesity, Abdominal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Electro-acupunctureDevice
The acupoints of electro-acupuncture will be selected as Zusanli ,Sanyinjiao ,Zhongwan , Tianshu , Shuifen , Daheng ,Daimai , Shuidao ,Huaroumen and Fujie . We will deliver electrical stimulation with dense-disperse waves at 50 Hz and 10 V through the electrical acupuncture stimulation instrument to the abdominal points. The bodily needles will be retained for 30 minutes . Electro-acupuncture treatment will be applied 3 times a week, once every other day, for 8 consecutive weeks.
Sham electro-acupunctureDevice
The acupoints of sham electro-acupuncture will be selected as nonacupoints . The internal output power cord of the electrical acupuncture stimulation instrument will be interrupted. The bodily needles will be retained for 30 minutes . Sham acupuncture treatment will be applied 3 times a week, once every other day, for 8 consecutive weeks.

Study groups in NCT04957134
Study group	Role	What they receive
Electro-acupuncture	Experimental	Participants will receive electro-acupuncture combined with lifestyle intervention. Participants will receive the treatment of electroacupuncture 3 times a week to fulfill a 8-session treatment course. Receives: Device: Electro-acupuncture
Sham electro-acupuncture	Placebo comparator	Participants will receive the treatment of sham electro-acupuncture 3 times a week to fulfill a 8-session treatment course, A superficial skin penetration (2-3 mm in depth) at nonacupoints will be performed in the sham acupuncture group, without needle manipulation for De qi. The internal output power cord of the electrical acupuncture stimulation instrument is interrupted. Receives: Device: Sham electro-acupuncture

What is being measured

The primary outcome is the main question the study is designed to answer.

Change from baseline waistline at 8 weeks.
Waistline will be measured around the abdomen at the level of the umbilicus (belly button).
Measured: week 0,week 4,week 8,week 20,week 32

Secondary outcomes (10)

Change from baseline body weight at 8 weeks.
Body weight will be measured by a body composition analyzer (OMRON V.BODY).
Measured: week 0,week 4,week 8,week 20,week 32
Change from baseline body mass index at 8 weeks.
Body Mass Index is a simple calculation using a person's height and weight. The formula is BMI = kg/m2 where kg is a person's weight in kilograms and m2 is their height in metres squared.
Measured: week 0,week 4,week 8,week 20,week 32
Change from baseline the body fat percentage at 8 weeks.
The body fat percentage (BFP) of a human or other living being is the total mass of fat divided by total body mass, multiplied by 100. Body fat percentage will be measured by a body composition analyzer (OMRON V.BODY).
Measured: week 0,week 8,week 32
Change from baseline hip circumference at 8 weeks.
Hip circumference will be measured at the level of maximum posterior extension of the buttocks.
Measured: week 0,week 4,week 8,week 20,week 32
Change from baseline waist-to-hip ratio at 8 weeks.
Waist-to-hip ratio is the dimensionless ratio of the circumference of the waist to that of the hips. This is calculated as waist measurement divided by hip measurement ( W ÷ H ).
Measured: week 0,week 4,week 8,week 20,week 32
Changes from baseline insulin resistance index at 8 weeks.
Examined with the blood sample.
Measured: week 0, week 8
Changes from baseline blood fat at 8 weeks.
Examined with the blood sample.
Measured: week 0, week 8
Changes from baseline blood pressure at 8 weeks
Both Systolic and diastolic blood pressure assessed by office and ambulatory blood pressure monitoring(mmHg).
Measured: week 0,week 4,week 8,week 32
Changes from baseline the IWQOL - Lite scale score at 8 weeks
Quality of life was examined using the Impact of Weight on Quality of Life (IWQOL) questionnaire, which has a score range from 0(worst) to 100(best).
Measured: week 0,week 8,week 32
Changes from baseline the Kessler 10 scale at 8weeks.
10 item self-report measure of psychological distress with five response categories (none of the time, a little of the time, some of the time, most of the time, all of the time). Scores range from 10 to 50; a higher score indicates more psychological distress.
Measured: week 0,week 8,week 32

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Jul 202115 Mar 2023

First posted12 Jul 2021
Study start22 Jul 2021
Primary completion15 Mar 2023
Study completion15 Mar 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (23)Papers the sponsor has linked to this study.
Other trials for Obesity, AbdominalStudies 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: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 66 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04957134
Sponsor's protocol ID: ZY2021Z004
Status last verified: Jun 2023
First submitted: 24 Jun 2021
Last updated: 12 Jun 2023
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: The overall data outcome will be published in the form of public paper before december 2024.

Publications

Carbone A, Al Salhi Y, Tasca A, Palleschi G, Fuschi A, De Nunzio C, Bozzini G, Mazzaferro S, Pastore AL. Obesity and kidney stone disease: a systematic review. Minerva Urol Nefrol. 2018 Aug;70(4):393-400. doi: 10.23736/S0393-2249.18.03113-2. Epub 2018 May 31.
PubMed 29856171
Zhang N, Du SM, Ma GS. Current lifestyle factors that increase risk of T2DM in China. Eur J Clin Nutr. 2017 Jul;71(7):832-838. doi: 10.1038/ejcn.2017.41. Epub 2017 Apr 19.
PubMed 28422119
Garvey WT, Mechanick JI, Brett EM, Garber AJ, Hurley DL, Jastreboff AM, Nadolsky K, Pessah-Pollack R, Plodkowski R; Reviewers of the AACE/ACE Obesity Clinical Practice Guidelines. AMERICAN ASSOCIATION OF CLINICAL ENDOCRINOLOGISTS AND AMERICAN COLLEGE OF ENDOCRINOLOGY COMPREHENSIVE CLINICAL PRACTICE GUIDELINES FOR MEDICAL CARE OF PATIENTS WITH OBESITY. Endocr Pract. 2016 Jul;22 Suppl 3:1-203. doi: 10.4158/EP161365.GL. Epub 2016 May 24.
PubMed 27219496
Biemann R, Roomp K, Noor F, Krishnan S, Li Z, Shahzad K, Borucki K, Luley C, Schneider JG, Isermann B. Gene expression profile of CD14+ blood monocytes following lifestyle-induced weight loss in individuals with metabolic syndrome. Sci Rep. 2020 Oct 20;10(1):17855. doi: 10.1038/s41598-020-74973-2.
PubMed 33082492
Lee JJ, Sundar KM. Evaluation and Management of Adults with Obstructive Sleep Apnea Syndrome. Lung. 2021 Apr;199(2):87-101. doi: 10.1007/s00408-021-00426-w. Epub 2021 Mar 13.
PubMed 33713177
Viner RM, Hsia Y, Tomsic T, Wong IC. Efficacy and safety of anti-obesity drugs in children and adolescents: systematic review and meta-analysis. Obes Rev. 2010 Aug;11(8):593-602. doi: 10.1111/j.1467-789X.2009.00651.x. Epub 2009 Nov 17.
PubMed 19922432
Chan EW, He Y, Chui CS, Wong AY, Lau WC, Wong IC. Efficacy and safety of lorcaserin in obese adults: a meta-analysis of 1-year randomized controlled trials (RCTs) and narrative review on short-term RCTs. Obes Rev. 2013 May;14(5):383-92. doi: 10.1111/obr.12015. Epub 2013 Jan 21.
PubMed 23331711
Scheen AJ, Van Gaal LF. Combating the dual burden: therapeutic targeting of common pathways in obesity and type 2 diabetes. Lancet Diabetes Endocrinol. 2014 Nov;2(11):911-22. doi: 10.1016/S2213-8587(14)70004-X. Epub 2014 Feb 19.
PubMed 24731666
Tronieri JS, Wadden TA, Walsh OA, Berkowitz RI, Alamuddin N, Gruber K, Leonard S, Chao AM. Effects of liraglutide plus phentermine in adults with obesity following 1 year of treatment by liraglutide alone: A randomized placebo-controlled pilot trial. Metabolism. 2019 Jul;96:83-91. doi: 10.1016/j.metabol.2019.03.005. Epub 2019 Mar 20.
PubMed 30902750
Liang CM, Hu H, Wang CX, Sun SG, Yang WJ, Pan L. [Randomized Controlled Clinical Trials for Acupuncture Treatment of Abdominal Obesity]. Zhen Ci Yan Jiu. 2016 Apr;41(2):159-62, 174. Chinese.
PubMed 27323445
Liang CM, Hu H, Li YY. [Acupuncture treatment of abdominal obesity patients by "belt vessel (Daimai) regulating method"]. Zhen Ci Yan Jiu. 2012 Dec;37(6):493-6. Chinese.
PubMed 23383460
Zhang YJ, Li J, Huang W, Mo GY, Wang LH, Zhuo Y, Zhou ZY. [Effect of electroacupuncture combined with treadmill exercise on body weight and expression of PGC-1alpha， Irisin and AMPK in skeletal muscle of diet-induced obesity rats]. Zhen Ci Yan Jiu. 2019 Jul 25;44(7):476-80. doi: 10.13702/j.1000-0607.180460. Chinese.
PubMed 31368276
Huang W, Chen X, Zhang Y, Wang L, Wang J, Zhang Y, Wei D, Zhou Z. Acupoint catgut embedding for obesity: A protocol of systematic review. Medicine (Baltimore). 2020 Dec 18;99(51):e23728. doi: 10.1097/MD.0000000000023728.
PubMed 33371124
Chen X, Huang W, Wei D, Ding DG, Jiao Y, Pan HL, Jin YT, Zheng YW, Zhang YJ, Zhang YR, Liu YR, Zhou ZY. Clinical effect of catgut implantation at acupoints for the treatment of simple obesity: A multicentre randomized controlled trial. Medicine (Baltimore). 2020 Nov 25;99(48):e23390. doi: 10.1097/MD.0000000000023390.
PubMed 33235115
Chen X, Huang W, Hu F, Jin YT, Hong ZH, Zhou ZY. [Regularity of Acupoint Selection for Simple Obesity Treated by Acupoint Catgut Embedding Based on Complex Network Technology]. Zhen Ci Yan Jiu. 2018 Sep 25;43(9):585-90. doi: 10.13702/j.1000-0607.170448. Chinese.
PubMed 30232869

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 12 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Efficacy and Safety of Electro-acupuncture for Abdominal Obesity: Original Study for a Multicenter, Randomized, Sham-controlled Trial
ClinicalTrials.gov ID: NCT04957134
Acronym / sponsor ID: ZY2021Z004
Conditions: Obesity, Abdominal
Keywords: Abdominal obesity, Electro-acupuncture, Randomized controlled trial
Study type: Interventional
Recruitment status: Completed
Enrolment: 66 participants (actual)
Lead sponsor: Hubei Hospital of Traditional Chinese MedicineUniversity, hospital or other
Study start: 22 Jul 2021 (actual)
Primary completion: 15 Mar 2023 (actual)
Study completion: 15 Mar 2023 (actual)
First posted: 12 Jul 2021 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Electro-acupuncture	Experimental	Device: Electro-acupunctureParticipants will receive electro-acupuncture combined with lifestyle intervention. Participants will receive the treatment of electroacupuncture 3 times a week to fulfill a 8-session treatment course.
Sham electro-acupuncture	Placebo comparator	Device: Sham electro-acupunctureParticipants will receive the treatment of sham electro-acupuncture 3 times a week to fulfill a 8-session treatment course, A superficial skin penetration (2-3 mm in depth) at nonacupoints will be performed in the sham acupuncture group, without needle manipulation for De qi. The internal output power cord of the electrical acupuncture stimulation instrument is interrupted.

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (2 listed)

Patients recruited for this study should meet the following inclusion criteria:
1.Satisfying the criteria for the diagnosis of abdominal obesity; 2.18 years old≤age≤55 years old; 3.Being able to fully understand and voluntarily sign informed consent.

Key exclusion criteria (10 listed)

Patients with any of the following criteria will be excluded from the study:

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
Electro-acupunctureThe acupoints of electro-acupuncture will be selected as Zusanli ,Sanyinjiao ,Zhongwan , Tianshu , Shuifen , Daheng ,Daimai , Shuidao ,Huaroumen and Fujie . We will deliver electrical stimulation with dense-disperse waves at 50 Hz and 10 V through the electrical acupuncture stimulation instrument to the abdominal points. The bodily needles will be retained for 30 minutes . Electro-acupuncture treatment will be applied 3 times a week, once every other day, for 8 consecutive weeks.	Device	Electro-acupuncture
Sham electro-acupunctureThe acupoints of sham electro-acupuncture will be selected as nonacupoints . The internal output power cord of the electrical acupuncture stimulation instrument will be interrupted. The bodily needles will be retained for 30 minutes . Sham acupuncture treatment will be applied 3 times a week, once every other day, for 8 consecutive weeks.	Device	Sham electro-acupuncture

Primary outcome

Change from baseline waistline at 8 weeks.
Time frame: week 0,week 4,week 8,week 20,week 32
Waistline will be measured around the abdomen at the level of the umbilicus (belly button).

10 secondary outcomes

Change from baseline body weight at 8 weeks.
Time frame: week 0,week 4,week 8,week 20,week 32
Change from baseline body mass index at 8 weeks.
Time frame: week 0,week 4,week 8,week 20,week 32
Change from baseline the body fat percentage at 8 weeks.
Time frame: week 0,week 8,week 32
Change from baseline hip circumference at 8 weeks.
Time frame: week 0,week 4,week 8,week 20,week 32
Change from baseline waist-to-hip ratio at 8 weeks.
Time frame: week 0,week 4,week 8,week 20,week 32
Changes from baseline insulin resistance index at 8 weeks.
Time frame: week 0, week 8
Changes from baseline blood fat at 8 weeks.
Time frame: week 0, week 8
Changes from baseline blood pressure at 8 weeks
Time frame: week 0,week 4,week 8,week 32
Changes from baseline the IWQOL - Lite scale score at 8 weeks
Time frame: week 0,week 8,week 32
Changes from baseline the Kessler 10 scale at 8weeks.
Time frame: week 0,week 8,week 32

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2023.
Background: PubMed 29856171Carbone A, Al Salhi Y, Tasca A, Palleschi G, Fuschi A, De Nunzio C, Bozzini G, Mazzaferro S, Pastore AL. Obesity and kidney stone disease: a systematic review. Minerva Urol Nefrol. 2018 Aug;70(4):393-400. doi: 10.23736/S0393-2249.18.03113-2. Epub 2018 May 31.
Background: PubMed 28422119Zhang N, Du SM, Ma GS. Current lifestyle factors that increase risk of T2DM in China. Eur J Clin Nutr. 2017 Jul;71(7):832-838. doi: 10.1038/ejcn.2017.41. Epub 2017 Apr 19.
Background: PubMed 27219496Garvey WT, Mechanick JI, Brett EM, Garber AJ, Hurley DL, Jastreboff AM, Nadolsky K, Pessah-Pollack R, Plodkowski R; Reviewers of the AACE/ACE Obesity Clinical Practice Guidelines. AMERICAN ASSOCIATION OF CLINICAL ENDOCRINOLOGISTS AND AMERICAN COLLEGE OF ENDOCRINOLOGY COMPREHENSIVE CLINICAL PRACTICE GUIDELINES FOR MEDICAL CARE OF PATIENTS WITH OBESITY. Endocr Pract. 2016 Jul;22 Suppl 3:1-203. doi: 10.4158/EP161365.GL. Epub 2016 May 24.
Background: PubMed 33082492Biemann R, Roomp K, Noor F, Krishnan S, Li Z, Shahzad K, Borucki K, Luley C, Schneider JG, Isermann B. Gene expression profile of CD14+ blood monocytes following lifestyle-induced weight loss in individuals with metabolic syndrome. Sci Rep. 2020 Oct 20;10(1):17855. doi: 10.1038/s41598-020-74973-2.
Background: PubMed 33713177Lee JJ, Sundar KM. Evaluation and Management of Adults with Obstructive Sleep Apnea Syndrome. Lung. 2021 Apr;199(2):87-101. doi: 10.1007/s00408-021-00426-w. Epub 2021 Mar 13.
Background: PubMed 19922432Viner RM, Hsia Y, Tomsic T, Wong IC. Efficacy and safety of anti-obesity drugs in children and adolescents: systematic review and meta-analysis. Obes Rev. 2010 Aug;11(8):593-602. doi: 10.1111/j.1467-789X.2009.00651.x. Epub 2009 Nov 17.
Background: PubMed 23331711Chan EW, He Y, Chui CS, Wong AY, Lau WC, Wong IC. Efficacy and safety of lorcaserin in obese adults: a meta-analysis of 1-year randomized controlled trials (RCTs) and narrative review on short-term RCTs. Obes Rev. 2013 May;14(5):383-92. doi: 10.1111/obr.12015. Epub 2013 Jan 21.
Background: PubMed 24731666Scheen AJ, Van Gaal LF. Combating the dual burden: therapeutic targeting of common pathways in obesity and type 2 diabetes. Lancet Diabetes Endocrinol. 2014 Nov;2(11):911-22. doi: 10.1016/S2213-8587(14)70004-X. Epub 2014 Feb 19.
Background: PubMed 30902750Tronieri JS, Wadden TA, Walsh OA, Berkowitz RI, Alamuddin N, Gruber K, Leonard S, Chao AM. Effects of liraglutide plus phentermine in adults with obesity following 1 year of treatment by liraglutide alone: A randomized placebo-controlled pilot trial. Metabolism. 2019 Jul;96:83-91. doi: 10.1016/j.metabol.2019.03.005. Epub 2019 Mar 20.
Background: PubMed 27323445Liang CM, Hu H, Wang CX, Sun SG, Yang WJ, Pan L. [Randomized Controlled Clinical Trials for Acupuncture Treatment of Abdominal Obesity]. Zhen Ci Yan Jiu. 2016 Apr;41(2):159-62, 174. Chinese.
Background: PubMed 23383460Liang CM, Hu H, Li YY. [Acupuncture treatment of abdominal obesity patients by "belt vessel (Daimai) regulating method"]. Zhen Ci Yan Jiu. 2012 Dec;37(6):493-6. Chinese.
Background: PubMed 31368276Zhang YJ, Li J, Huang W, Mo GY, Wang LH, Zhuo Y, Zhou ZY. [Effect of electroacupuncture combined with treadmill exercise on body weight and expression of PGC-1alpha， Irisin and AMPK in skeletal muscle of diet-induced obesity rats]. Zhen Ci Yan Jiu. 2019 Jul 25;44(7):476-80. doi: 10.13702/j.1000-0607.180460. Chinese.
Individual participant dataSharing planned: No. The overall data outcome will be published in the form of public paper before december 2024.

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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. This study is not recruiting at the moment.

Zhongyu Zhou, Professor principal investigator

Hubei Hospital of Traditional Chinese Medicine

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Electro-acupuncture in people with Obesity, Abdominal, run by Hubei 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 2 inclusion and 10 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: finished, as of the sponsor's last update on 12 Jun 2023. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline waistline at 8 weeks. (time frame: week 0,week 4,week 8,week 20,week 32). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04957134, which also lists 23 linked publications.

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 12 Jun 2023.