Electroacupuncture Combined With Umbilical Moxibustion on Abdominal Obesity of Yang Deficiency

Not Applicable

• Conditions: Obesity, Abdominal
• Interventions: Behavioral: Electroacupuncture; Behavioral: Electroacupuncture combined with umbilical moxibustion

• Registration Number: NCT04835181
• Lead Sponsor: Hubei Hospital of Traditional Chinese Medicine

Brief Summary

Obesity is a chronic metabolic disease that seriously harms human health, while abdominal obesity is more closely related to diseases such as type 2 diabetes, cardiovascular disease, and tumors, and has a higher risk. In recent years, traditional Chinese medicine therapy has become the choice of more and more obese patients, and acupuncture therapy is also known as a green therapy for weight loss due to its safety and no side effects. Through the analysis of the TCM physique types of obese people, it is found that Yang-deficiency constitution is one of the TCM constitution types closely related to simple obesity. This topic is based on the constitution theory of traditional Chinese medicine, and on the basis of the earlier research that has clarified the weight loss and lipid-lowering effects of electroacupuncture, it further aims at the type of yang deficiency in obese people, and clarifies the regulation and improvement of umbilical moxibustion on the constitution of obese patients with yang deficiency. In this project, patients with abdominal obesity with yang-deficiency constitution were divided into electro-acupuncture + umbilical moxibustion group and electro-acupuncture group to observe and analyze the advantages and effects of electro-acupuncture combined with umbilical moxibustion on the improvement of obesity symptoms and physical fitness of patients. The ELISA method was used to determine the metabolic indexes related to yang-deficiency constitution, to further clarify the material basis of electroacupuncture combined with umbilical moxibustion to improve the yang-deficiency constitution of patients with abdominal obesity, and to provide scientific and reasonable theoretical guidance for clinical treatment.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-02
• Study First Submitted: 2021-03-31
• Study Start: 2021-04-01
• Study First Submitted QC: 2021-04-05
• Last Update Submitted: 2021-04-05
• Study First Posted: 2021-04-08
• Last Update Posted: 2021-04-08
• Primary Completion: 2021-12-01
• Study Completion: 2022-01-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 68

Inclusion Criteria

1. People who meet the following diagnostic criteria and are diagnosed with abdominal obesity due to yang deficiency:

2. Diagnostic criteria for abdominal obesity: Refer to the criteria in the "Guidelines for the Comprehensive Medical Management of Obese People" jointly issued by the American Academy of Clinical Endocrinologists (AACE) and the American College of Endocrinology (ACE) in May 2016: male waist circumference ≥85cm, female Waist circumference ≥80cm can be diagnosed as abdominal obesity.

3. Yang Deficiency Quality Criteria: Meet the diagnostic criteria of Yang Deficiency in the "Classification and Judgment Table of Traditional Chinese Medicine Constitution". Common manifestations are chills, cold limbs, swollen face, pale complexion, pale tongue, white slippery fur, and weak pulse.

4. Age: 18 to 55 years old; 3. Sign the informed consent and voluntarily accept the intervention method of this project.

Exclusion Criteria

1. Severe lung, heart, liver, kidney and other diseases;
2. Combined endocrine diseases (polycystic ovary syndrome, hypothyroidism, Cushing syndrome, etc.);
3. Have a history of surgery to lose weight; have a history of adhesions after previous surgery;
4. Have taken drugs that are known to affect weight or appetite in the past 3 months, such as weight loss drugs, corticosteroids, etc.; have used hormone drugs, lipid-lowering drugs, and hypoglycemic drugs in the past 3 months;
5. Women during pregnancy, lactation and menopause;
6. Participated in clinical research on weight loss in the past 3 months; Those who meet any of the above will be excluded from the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Electroacupuncture	Electroacupuncture	-
Electroacupuncture combined with umbilical moxibustion	Electroacupuncture combined with umbilical moxibustion	-

Primary Outcome Measures

Name	Time	Method
Change from baseline Waist circumference(WC) at week 12	Baseline and Week 12	The horizontal girth through the center of the umbilicus

Secondary Outcome Measures

Name	Time	Method
BMI(weight/(height)	Week 0, Week 4, Week 8, Week 12	BMI (weight/(height) will be measured.
hip circumference(HC)	Week 0, Week 4, Week 8, Week 12	hip circumference(HC) will be measured.
Serum corticosterone (CORT)	Week 0, Week 8	Serum corticosterone (CORT) will be measured to assist in reflecting changes in participants' Yang deficiency constitution.
Weight(WG)	Week 0, Week 4, Week 8, Week 12	Weight(WG) will be measured.
Waist-to-hip ratio(waist circumference/hip circumference)	Week 0, Week 4, Week 8, Week 12	waist-to-hip ratio(waist circumference/hip circumference) will be measured.
The impact of weight on quality of life (IWQOL)-Lite scale	Week 0, Week 4, Week 8, Week 12	The impact of weight on quality of life (IWQOL)- Lite scale will be measured to assess the improvement in the quality of life of participants. The minimum value is 31，the maximum value is 155. The lower the total score, the lighter the clinical symptoms of the patient.
The 10-item Kessler Psychological Distress (K10) Scale	Week 0, Week 4, Week 8, Week 12	The 10-item Kessler Psychological Distress (K10) Scale will be measured to assess participant's mental state. The minimum value is 10，the maximum value is 50. The lower the total score, the lighter the clinical symptoms of the patient.
TCM Physique Classification and Judgment Table	Week 0, Week 4, Week 8, Week 12	Refer to the physical characteristics in the "Traditional Chinese Medicine Physique Classification and Judgment Table" to determine the changes in the yang deficiency constitution of the participants. The symptom score is quantified in 5 levels: always, 5 points; often, 4 points; sometimes, 3 points; very Less, 2 points, no, 1 point. Then calculate the constitutional symptom conversion score, and the change value of the constitutional symptom conversion score compared with the baseline.The minimum value is 0，the maximum value is 100. The lower the total score, the lighter the clinical symptoms of the patient.
Serum adrenocorticotropic hormone (ACTH)	Week 0, Week 8	Serum adrenocorticotropic hormone (ACTH) will be measured to assist in reflecting changes in participants' Yang deficiency constitution.
Serum cortisol (FC)	Week 0, Week 8	Serum cortisol (FC) will be measured to assist in reflecting changes in participants' Yang deficiency constitution.