NCT02936973

Catgut Implantation at Acupoints for the Treatment of Simple Obesity

Clinical Effect of Catgut Implantation at Acupoints for the Treatment of Simple Obesity: a Multicentre Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 216 (actual)
• Sponsor: Hubei Hospital of Traditional Chinese Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Obesity

Interventions

Type	Name	Description
DEVICE	Real catgut implantation at acupoints	1. 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	sham catgut implantation at acupoints	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.

Timeline

• Start date: 2017-02-15
• Primary completion: 2018-05-15
• Completion: 2018-05-15
• First posted: 2016-10-18
• Last updated: 2019-12-05

Locations

1 site across 1 country: China