Clinical trial NCT04835181: Electroacupuncture Combined With Umbilical Moxibustion on Abdominal Obesity of Yang Deficiency
Official title: Electroacupuncture Combined With Umbilical Moxibustion on Abdominal Obesity of Yang Deficiency: A Study Protocol for a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity, Abdominal
Lead sponsor: Hubei Hospital of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2021-04-08
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

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

1. 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.
2. 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.

2. 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.

Primary outcomes:
measure: Change from baseline Waist circumference(WC) at week 12
timeFrame: Baseline and Week 12
Secondary outcomes:
measure: Weight(WG)
timeFrame: Week 0, Week 4, Week 8, Week 12
measure: BMI(weight/(height)
timeFrame: Week 0, Week 4, Week 8, Week 12
measure: hip circumference(HC)
timeFrame: Week 0, Week 4, Week 8, Week 12
measure: Waist-to-hip ratio(waist circumference/hip circumference)
timeFrame: Week 0, Week 4, Week 8, Week 12
measure: The impact of weight on quality of life (IWQOL)-Lite scale
timeFrame: Week 0, Week 4, Week 8, Week 12
measure: The 10-item Kessler Psychological Distress (K10) Scale
timeFrame: Week 0, Week 4, Week 8, Week 12
measure: TCM Physique Classification and Judgment Table
timeFrame: Week 0, Week 4, Week 8, Week 12
measure: Serum cortisol (FC)
timeFrame: Week 0, Week 8
measure: Serum corticosterone (CORT)
timeFrame: Week 0, Week 8
measure: Serum adrenocorticotropic hormone (ACTH)
timeFrame: Week 0, Week 8
Other outcomes:
Locations:
Study officials:
affiliation: Hubei Hospital of Traditional Chinese Medicine
name: Zhong-Yu Zhou, MD
role: PRINCIPAL_INVESTIGATOR
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