Catgut Implantation at Acupoints for the Treatment of Simple Obesity

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.

Conditions

• Obesity

Interventions

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.

Sponsors & Collaborators

• State Administration of Traditional Chinese Medicine of the People's Republic of China

  collaborator OTHER_GOV

• Dongzhimen Hospital, Beijing

  collaborator OTHER

• The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine

  collaborator OTHER

• Hubei Hospital of Traditional Chinese Medicine

  lead OTHER

Principal Investigators

• Zhongyu Zhou, Professor · Hubei Hospital of Traditional Chinese Medicine

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

45 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-02-15

Primary Completion

2018-05-15

Completion

2018-05-15

Countries

• China

Study Locations