ObesityNCT02936973
Catgut Implantation at Acupoints for the Treatment of Simple Obesity
A study testing Real catgut implantation at acupoints in people with Obesity, run by Hubei Hospital of Traditional Chinese Medicine at 1 site in China.
Trial summary
The primary objective of this multicenter randomized controlled trial is to evaluate treatment effectiveness of intervening simple obesity people with catgut implantation at preferred acupoints, which excludes placebo effect; the secondary objective is to evaluate safety and superiority of treating simple obesity with… Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Obesity
- What is being tested?
- Real catgut implantation at acupoints
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 216 participants
- Where
- 1 siteChina
- Study dates
- 15 Feb 2017to 15 May 2018
- 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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients recruited for this study should meet the following inclusion criteria:
- meeting the diagnosis standard for simple obesity in Redefinition and Processing of Obesity in Asia \& Pacific Area released by WHO in February 2000;
- age: 18-45;
- BMI: 25≤BMI<30;
- waistline: males ≥95 cm; females ≥85 cm;
- smokers have not changed their smoking habits for at least 2 months;
- willing to accept the above-described intervention methods.
Who cannot join
- Patients with any of the following criteria will be excluded from the study:
- endocrine disease (such as polycystic ovarian syndrome, Cushing's Disease, and hypothyroidism, among others);
- gestational diabetes or uncontrolled hypertension (SBP ≥160 mmHg; DBP ≥100 mmHg) [23], or lung, heart, liver or kidney disease;
- nervous system disease or mental disorders, history of hospitalized depression, two instances of paralepsy or suicidal tendency;
- history of clinical diagnosis of an eating disorder , such as bulimia or cynorexia, anorexia; or weight changes greater than 5 kg in the previous 3 months;
- history of weight loss with surgery or a history of post-operative adhesion;
Show all 14Show fewer
- having taken drugs with a known influence on weight or appetite in the previous 3 months, such as diet pills, corticosteroid drugs, anti-depression drugs, diazepam drugs, nonselective body antihistamine, nicotine replacements, or hypoglycaemic drugs, or planning to give up smoking and drinking;
- pregnancy, lactation, or planning to become pregnant within 40 weeks;
- received catgut implantation at acupoints;
- participated in clinical research on obesity in the previous 3 months ;
- protein allergy and scars;
- skin disease such as eczema and psoriasis;
- coagulation disorders, taking warfarin, heparin or other anticoagulant drugs;
- not cooperative or cannot maintain treatment during the study period.
Trial locations and contacts
1 site in 1 country.
China1 site
Hubei Provincial Hospital of Traditional Chinese Medicine
Wuhan, Hubei, 430061
About this study
Official title: Clinical Effect of Catgut Implantation at Acupoints for the Treatment of Simple Obesity: a Multicentre Randomized Controlled Trial
The primary objective of this multicenter randomized controlled trial is to evaluate treatment effectiveness of intervening simple obesity people with catgut implantation at preferred acupoints, which excludes placebo effect; the secondary objective is to evaluate safety and superiority of treating simple obesity with catgut implantation at acupoints to provide high-level evidence for it clinically.
Read the detailed description
This randomized, double-blind sham-controlled clinical trial will be conducted at Hubei Provincial Hospital of TCM, Dongzhimen Hospital Beijing University of Chinese Medicine and the First Hospital of Hunan University of Chinese Medicine. This study includes the following time points: a treatment period of 16 weeks after screening and a follow-up period of 24 weeks. The total study period will be 40 weeks. All patients will be randomized into the real catgut implantation at acupoints group or the sham catgut implantation at acupoints group.The primary outcome measurement of this study is the rate of waistline reduction compared with baseline. The secondary outcome measurements are the rate of reduction of weight, BMI, hipline, WHR and PBF, and changes in the IWQOL-Lite compared with baseline. These parameters will be evaluated at week 0, week 4, week 8, week 12, week 16, week 28 and week 40. Changes in SF-36, HAD and SES compared with baseline will be evaluated at week 0, week 16 and week 40. SF-36 and IWQOL-Lite will be used to evaluate obese patient quality of life. HAD and SES will be used to evaluate psychological status. In addition, hepatorenal function, blood fat, liver bladder spleen colour ultrasound, FBG and insulin concentration will be used to evaluate whether catgut implantation at acupoints can improve the physiological function of obese patients.
- Conditions
- Obesity
- Being tested
- Real catgut implantation at acupoints, sham catgut implantation at acupoints
- Keywords
- simple obesity, catgut implantation
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Real catgut implantation at acupointsDevice
- Absorbable surgical suture will be embedded in acupoints as below. Group A ：Zhigou (TE 6), Tianshu (ST25), Weishu (BL21), Zhongwan (CV12) and Zusanli (ST36); Group B ：Quchi (LI11), Huaroumen (ST24), Pishu (BL20), Shuifen (CV9), and Fenglong (ST40). Each group will be used alternatively and treated once every 2 weeks.
- lifestyle intervention :Experienced nutritionists calculated every participant's basal metabolic rate,then designed a proper diet and exercise treatment for them. During the treatment, a diet and exercise diary will be distributed to the patients, and detailed guidance concerning their diet and exercise will be provided according to the diary. The patients should be encouraged to maintain the diet and exercise diary for at least 4 days per week .
sham catgut implantation at acupointsDevice
Empty needles without catgut will be pushed into the chosen position as below :Group A ：1 cun lateral from the Zhigou (TE 6), Tianshu (ST25), Weishu (BL21), Zhongwan (CV12) and Zusanli (ST36); Group B ：1 cun lateral from the Quchi (LI11), Huaroumen (ST24), Pishu (BL20), Shuifen (CV9), and Fenglong (ST40).Those two groups of acupoints will ultimately be selected for alternative treatment. Each group will be used alternatively and treated once every 2 weeks.
lifestyle intervention :It will be performed as the same as the real catgut implantation at acupoints group.
| Study group | Role | What they receive |
|---|---|---|
| Real catgut implantation | Experimental | Participants will receive real catgut implantation at acupoints plus lifestyle modification. Participants will receive catgut implantation treatment every two weeks to fulfill a 8-session treatment course.When the acupoints and surrounding skin are disinfected, an absorbable surgical suture of an appropriate length will be embedded into the muscular layer or subcutaneous tissue of the acupoints by the specified disposable embedding needles. The absorbable surgical suture then stimulated those points over a long period. Receives: Device: Real catgut implantation at acupoints |
| sham catgut implantation | Sham comparator | Participants will receive sham catgut implantation at acupoints and lifestyle modification every two weeks to fulfill a 8-session treatment course.The operation process will be similar to that applied in the real catgut implantation group. Empty needles without catgut will be pushed into the chosen position, to a depth equivalent to that used for catgut implantation at acupoints. The frequency and duration were the the same as the catgut embedding group. Receives: Device: sham catgut implantation at acupoints |
What is being measured
The primary outcome is the main question the study is designed to answer.
the rate of waistline reduction compared with baseline
Measured: week4 ,week8,week12,week16,week28,week40.
Secondary outcomes (16)
the rate of reduction of weight compared with baseline
Measured: week4 ,week8,week12,week16,week28,week40.
the rate of reduction of body mass index compared with baseline
Measured: week4 ,week8,week12,week16,week28,week40.
the rate of reduction of hipline compared with baseline
Measured: week4 ,week8,week12,week16,week28,week40.
the rate of reduction of waist-hip ratio compared with baseline
Measured: week4 ,week8,week12,week16,week28,week40.
the rate of reduction of percentage of body fat compared with baseline
Measured: week4 ,week8,week12,week16,week28,week40.
changes in IWQOL - Lite scale score compared with baseline
Measured: week4 ,week8,week12,week16,week28,week40.
changes in SF - 36 life quality scale score compared with baseline
Measured: week4 ,week16,week40.
changes in HAD scale score compared with baseline
Measured: week4 ,week16,week40.
changes in self-esteem scale score compared with baseline
Measured: week4 ,week16,week40.
changes in serum total cholesterol compared with baseline
Measured: week16.
changes in serum triglyceride compared with baseline
Measured: week16.
changes in low-density lipoprotein cholesterol (LDL-C) compared with baseline
Measured: week16.
changes in High-density lipoprotein cholesterol(HDL-C) compared with baseline
Measured: week16.
changes in fasting blood-glucose （FBG）compared with baseline
Measured: week16.
changes in fasting insulin ( FINS) compared with baseline
Measured: week16.
The adverse effects of catgut implantation at acupoints and as measured by number of participants with adverse events.
The adverse effects of catgut implantation at acupoints include local swelling, pruritus, fever, festering and unbearable pain. In the event of an adverse effect during the trial, the patient should immediately contact the physician. All adverse effects should be promptly recorded.
Measured: from week 2 to week 16.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2016 (estimated)
- Study start15 Feb 2017
- Primary completion15 May 2018
- Study completion15 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 216 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hubei Hospital of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- State Administration of Traditional Chinese Medicine of the People's Republic of China, Dongzhimen Hospital, Beijing, The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine
- Responsible party
- Sponsor
- Investigators
- Zhongyu Zhou, Professor, Principal investigator, Hubei Hospital of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02936973
- Sponsor's protocol ID
- 201507003
- Other IDs
- ChiCTR-IOR-16008384
- Status last verified
- Dec 2019
- First submitted
- 8 Oct 2016
- Last updated
- 5 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: the data will be published in the form of public papers before May 2019 for public inquiries
Publications
Scheen AJ, Finer N, Hollander P, Jensen MD, Van Gaal LF, RIO-Diabetes Study Group. Efficacy and tolerability of rimonabant in overweight or obese patients with type 2 diabetes: a randomised controlled study. Lancet. 2006;368:1660-72. Preljevic VT, Østhus TB, Sandvik L, Opjordsmoen S, Nordhus IH, Os I, et al. Screening for anxiety and depression in dialysis patients: comparison of the Hospital Anxiety and Depression Scale and the Beck Depression Inventory. J Psychosom Res. 2012;73:139-44. Van Gaal LF, Rissanen AM, Scheen AJ, Ziegler O, Rössner S, RIO-Europe Study Group. Effects of the cannabinoid-1 receptor blocker rimonabant onweight reduction and cardiovascular risk factors in overweight patients: 1-year experience from the RIO-Europe study. Lancet. 2005;365:1389-97. Rosenberg M. Society and the adolescent self-image. Princeton, NJ: Princeton University Press; 1965. World Health Organization, Regional Office for the Western Pacific. The Asia-Pacific perspective: redefining obesity and its treatment. Sydney: Health Communications Australia; 2000. Astrup A, Madsbad S, Breum L, Jensen TJ, Kroustrup JP, Larsen TM. Effect of tesofensine on bodyweight loss, body composition, and quality of life in obese patients: a randomised, double-blind, placebo-controlled trial. Lancet. 2008;372:1906-13. MacPherson H, White A, Cummings M, Jobst KA, Rose K, Niemtzow RC, et al. Standards for reporting interventions in controlled trials of acupuncture: the STRICTA recommendations. J Altern Complement Med. 2002;8:85 - 9. Ralph JL, Von Ah D, Scheett AJ, Hoverson BS, Anderson CM. Diet assessment methods: a guide for oncology nurses. Clin J Oncol Nurs. 2011;15:E114 - 21. James WP, Astrup A, Finer N, Hilsted J, Kopelman P, Rössner S, et al. Effect of sibutramine on weight maintenance after weight loss: a randomised trial. STORM Study Group. Sibutramine Trial of Obesity Reduction and Maintenance Lancet. 2000;356:2119-25.
Chen X, Huang W, Wei D, Zhao JP, Zhang W, Ding DG, Jiao Y, Pan HL, Zhang JJ, Zhong F, Gao F, Jin YT, Zheng YW, Zhang YJ, Huang Q, Zeng XT, Zhou ZY. Effect of Acupoint Catgut Embedding for Middle-Aged Obesity: A Multicentre, Randomised, Sham-Controlled Trial. Evid Based Complement Alternat Med. 2022 Feb 27;2022:4780019. doi: 10.1155/2022/4780019. eCollection 2022.
PubMed 35265146Chen 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
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Effect of Catgut Implantation at Acupoints for the Treatment of Simple Obesity: a Multicentre Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02936973
- Acronym / sponsor ID
- 201507003
- Conditions
- Obesity
- Keywords
- simple obesity, catgut implantation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 216 participants (actual)
- Lead sponsor
- Hubei Hospital of Traditional Chinese MedicineUniversity, hospital or other
- Collaborators
- State Administration of Traditional Chinese Medicine of the People's Republic of China, Dongzhimen Hospital, Beijing, The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine
- Study start
- 15 Feb 2017 (actual)
- Primary completion
- 15 May 2018 (actual)
- Study completion
- 15 May 2018 (actual)
- First posted
- 18 Oct 2016 (estimated)
- 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.
The primary objective of this multicenter randomized controlled trial is to evaluate treatment effectiveness of intervening simple obesity people with catgut implantation at preferred acupoints, which excludes placebo effect; the secondary objective is to evaluate safety and superiority of treating simple obesity with catgut implantation at acupoints to provide high-level evidence for it clinically.
Detailed description
This randomized, double-blind sham-controlled clinical trial will be conducted at Hubei Provincial Hospital of TCM, Dongzhimen Hospital Beijing University of Chinese Medicine and the First Hospital of Hunan University of Chinese Medicine. This study includes the following time points: a treatment period of 16 weeks after screening and a follow-up period of 24 weeks. The total study period will be 40 weeks. All patients will be randomized into the real catgut implantation at acupoints group or the sham catgut implantation at acupoints group.The primary outcome measurement of this study is the rate of waistline reduction compared with baseline. The secondary outcome measurements are the rate of reduction of weight, BMI, hipline, WHR and PBF, and changes in the IWQOL-Lite compared with baseline. These parameters will be evaluated at week 0, week 4, week 8, week 12, week 16, week 28 and week 40. Changes in SF-36, HAD and SES compared with baseline will be evaluated at week 0, week 16 and week 40. SF-36 and IWQOL-Lite will be used to evaluate obese patient quality of life. HAD and SES will be used to evaluate psychological status. In addition, hepatorenal function, blood fat, liver bladder spleen colour ultrasound, FBG and insulin concentration will be used to evaluate whether catgut implantation at acupoints can improve the physiological function of obese patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Real catgut implantation | Experimental | Device: Real catgut implantation at acupointsParticipants will receive real catgut implantation at acupoints plus lifestyle modification. Participants will receive catgut implantation treatment every two weeks to fulfill a 8-session treatment course.When the acupoints and surrounding skin are disinfected, an absorbable surgical suture of an appropriate length will be embedded into the muscular layer or subcutaneous tissue of the acupoints by the specified disposable embedding needles. The absorbable surgical suture then stimulated those points over a long period. |
| sham catgut implantation | Sham comparator | Device: sham catgut implantation at acupointsParticipants will receive sham catgut implantation at acupoints and lifestyle modification every two weeks to fulfill a 8-session treatment course.The operation process will be similar to that applied in the real catgut implantation group. Empty needles without catgut will be pushed into the chosen position, to a depth equivalent to that used for catgut implantation at acupoints. The frequency and duration were the the same as the catgut embedding group. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- meeting the diagnosis standard for simple obesity in Redefinition and Processing of Obesity in Asia \& Pacific Area released by WHO in February 2000;
- age: 18-45;
- BMI: 25≤BMI<30;
- waistline: males ≥95 cm; females ≥85 cm;
- smokers have not changed their smoking habits for at least 2 months;
Key exclusion criteria (14 listed)
- endocrine disease (such as polycystic ovarian syndrome, Cushing's Disease, and hypothyroidism, among others);
- gestational diabetes or uncontrolled hypertension (SBP ≥160 mmHg; DBP ≥100 mmHg) [23], or lung, heart, liver or kidney disease;
- nervous system disease or mental disorders, history of hospitalized depression, two instances of paralepsy or suicidal tendency;
- history of clinical diagnosis of an eating disorder , such as bulimia or cynorexia, anorexia; or weight changes greater than 5 kg in the previous 3 months;
- history of weight loss with surgery or a history of post-operative adhesion;
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 |
|---|---|---|
| Real catgut implantation at acupoints1. Absorbable surgical suture will be embedded in acupoints as below. Group A ：Zhigou (TE 6), Tianshu (ST25), Weishu (BL21), Zhongwan (CV12) and Zusanli (ST36); Group B ：Quchi (LI11), Huaroumen (ST24), Pishu (BL20), Shuifen (CV9), and Fenglong (ST40). Each group will be used alternatively and treated once every 2 weeks. 2. lifestyle intervention :Experienced nutritionists calculated every participant's basal metabolic rate,then designed a proper diet and exercise treatment for them. During the treatment, a diet and exercise diary will be distributed to the patients, and detailed guidance concerning their diet and exercise will be provided according to the diary. The patients should be encouraged to maintain the diet and exercise diary for at least 4 days per week . | Device | Real catgut implantation |
| sham catgut implantation at acupointsEmpty needles without catgut will be pushed into the chosen position as below :Group A ：1 cun lateral from the Zhigou (TE 6), Tianshu (ST25), Weishu (BL21), Zhongwan (CV12) and Zusanli (ST36); Group B ：1 cun lateral from the Quchi (LI11), Huaroumen (ST24), Pishu (BL20), Shuifen (CV9), and Fenglong (ST40).Those two groups of acupoints will ultimately be selected for alternative treatment. Each group will be used alternatively and treated once every 2 weeks. lifestyle intervention :It will be performed as the same as the real catgut implantation at acupoints group. | Device | sham catgut implantation |
Primary outcome
the rate of waistline reduction compared with baseline
Time frame: week4 ,week8,week12,week16,week28,week40.
16 secondary outcomes
the rate of reduction of weight compared with baseline
Time frame: week4 ,week8,week12,week16,week28,week40.
the rate of reduction of body mass index compared with baseline
Time frame: week4 ,week8,week12,week16,week28,week40.
the rate of reduction of hipline compared with baseline
Time frame: week4 ,week8,week12,week16,week28,week40.
the rate of reduction of waist-hip ratio compared with baseline
Time frame: week4 ,week8,week12,week16,week28,week40.
the rate of reduction of percentage of body fat compared with baseline
Time frame: week4 ,week8,week12,week16,week28,week40.
changes in IWQOL - Lite scale score compared with baseline
Time frame: week4 ,week8,week12,week16,week28,week40.
changes in SF - 36 life quality scale score compared with baseline
Time frame: week4 ,week16,week40.
changes in HAD scale score compared with baseline
Time frame: week4 ,week16,week40.
changes in self-esteem scale score compared with baseline
Time frame: week4 ,week16,week40.
changes in serum total cholesterol compared with baseline
Time frame: week16.
changes in serum triglyceride compared with baseline
Time frame: week16.
changes in low-density lipoprotein cholesterol (LDL-C) compared with baseline
Time frame: week16.
changes in High-density lipoprotein cholesterol(HDL-C) compared with baseline
Time frame: week16.
changes in fasting blood-glucose （FBG）compared with baseline
Time frame: week16.
changes in fasting insulin ( FINS) compared with baseline
Time frame: week16.
The adverse effects of catgut implantation at acupoints and as measured by number of participants with adverse events.
Time frame: from week 2 to week 16.
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 5 Dec 2019.
- BackgroundScheen AJ, Finer N, Hollander P, Jensen MD, Van Gaal LF, RIO-Diabetes Study Group. Efficacy and tolerability of rimonabant in overweight or obese patients with type 2 diabetes: a randomised controlled study. Lancet. 2006;368:1660-72. Preljevic VT, Østhus TB, Sandvik L, Opjordsmoen S, Nordhus IH, Os I, et al. Screening for anxiety and depression in dialysis patients: comparison of the Hospital Anxiety and Depression Scale and the Beck Depression Inventory. J Psychosom Res. 2012;73:139-44. Van Gaal LF, Rissanen AM, Scheen AJ, Ziegler O, Rössner S, RIO-Europe Study Group. Effects of the cannabinoid-1 receptor blocker rimonabant onweight reduction and cardiovascular risk factors in overweight patients: 1-year experience from the RIO-Europe study. Lancet. 2005;365:1389-97. Rosenberg M. Society and the adolescent self-image. Princeton, NJ: Princeton University Press; 1965. World Health Organization, Regional Office for the Western Pacific. The Asia-Pacific perspective: redefining obesity and its treatment. Sydney: Health Communications Australia; 2000. Astrup A, Madsbad S, Breum L, Jensen TJ, Kroustrup JP, Larsen TM. Effect of tesofensine on bodyweight loss, body composition, and quality of life in obese patients: a randomised, double-blind, placebo-controlled trial. Lancet. 2008;372:1906-13. MacPherson H, White A, Cummings M, Jobst KA, Rose K, Niemtzow RC, et al. Standards for reporting interventions in controlled trials of acupuncture: the STRICTA recommendations. J Altern Complement Med. 2002;8:85 - 9. Ralph JL, Von Ah D, Scheett AJ, Hoverson BS, Anderson CM. Diet assessment methods: a guide for oncology nurses. Clin J Oncol Nurs. 2011;15:E114 - 21. James WP, Astrup A, Finer N, Hilsted J, Kopelman P, Rössner S, et al. Effect of sibutramine on weight maintenance after weight loss: a randomised trial. STORM Study Group. Sibutramine Trial of Obesity Reduction and Maintenance Lancet. 2000;356:2119-25.
- Derived from this study: PubMed 35265146Chen X, Huang W, Wei D, Zhao JP, Zhang W, Ding DG, Jiao Y, Pan HL, Zhang JJ, Zhong F, Gao F, Jin YT, Zheng YW, Zhang YJ, Huang Q, Zeng XT, Zhou ZY. Effect of Acupoint Catgut Embedding for Middle-Aged Obesity: A Multicentre, Randomised, Sham-Controlled Trial. Evid Based Complement Alternat Med. 2022 Feb 27;2022:4780019. doi: 10.1155/2022/4780019. eCollection 2022.
- Derived from this study: PubMed 33235115Chen 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.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. the data will be published in the form of public papers before May 2019 for public inquiries
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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 Real catgut implantation at acupoints in people with Obesity, 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 7 inclusion and 14 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 5 Dec 2019. 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?
the rate of waistline reduction compared with baseline (time frame: week4 ,week8,week12,week16,week28,week40.). 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 NCT02936973, which also lists 3 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 5 Dec 2019.