Catgut Implantation at Acupoints for the Treatment of Simple Obesity

Not Applicable

Completed

• Conditions: Obesity

• Registration Number: NCT02936973
• Lead Sponsor: Hubei Hospital of Traditional Chinese Medicine

Brief 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 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 Timeline

• Study First Submitted: 2016-10-08
• Study First Submitted QC: 2016-10-14
• Study First Posted: 2016-10-18
• Study Start: 2017-02-15
• Primary Completion: 2018-05-15
• Study Completion: 2018-05-15
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-03
• Last Update Posted: 2019-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 216

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
the rate of waistline reduction compared with baseline	week4 ,week8,week12,week16,week28,week40.

Secondary Outcome Measures

Name	Time	Method
the rate of reduction of body mass index compared with baseline	week4 ,week8,week12,week16,week28,week40.
changes in IWQOL - Lite scale score compared with baseline	week4 ,week8,week12,week16,week28,week40.
changes in HAD scale score compared with baseline	week4 ,week16,week40.
changes in serum total cholesterol compared with baseline	week16.
changes in fasting blood-glucose （FBG）compared with baseline	week16.
changes in fasting insulin ( FINS) compared with baseline	week16.
The adverse effects of catgut implantation at acupoints and as measured by number of participants with adverse events.	from week 2 to week 16.	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.
the rate of reduction of weight compared with baseline	week4 ,week8,week12,week16,week28,week40.
the rate of reduction of hipline compared with baseline	week4 ,week8,week12,week16,week28,week40.
the rate of reduction of waist-hip ratio compared with baseline	week4 ,week8,week12,week16,week28,week40.
the rate of reduction of percentage of body fat compared with baseline	week4 ,week8,week12,week16,week28,week40.
changes in SF - 36 life quality scale score compared with baseline	week4 ,week16,week40.
changes in self-esteem scale score compared with baseline	week4 ,week16,week40.
changes in low-density lipoprotein cholesterol (LDL-C) compared with baseline	week16.
changes in High-density lipoprotein cholesterol(HDL-C) compared with baseline	week16.
changes in serum triglyceride compared with baseline	week16.

Trial Locations

Locations (1)

Hubei Provincial Hospital of Traditional Chinese Medicine; 🇨🇳 Wuhan, Hubei, China