Electroacupuncture Combined With Umbilical Moxibustion on Abdominal Obesity of Yang Deficiency

Study Overview
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Brief Summary
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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.

Official Title
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Electroacupuncture Combined With Umbilical Moxibustion on Abdominal Obesity of Yang Deficiency: A Study Protocol for a Randomized Controlled Trial

Conditions
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Obesity, Abdominal

Intervention / Treatment
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* Behavioral: Electroacupuncture combined with umbilical moxibustion
* Behavioral: Electroacupuncture


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1. People who meet the following diagnostic criteria and are diagnosed with abdominal obesity due to yang deficiency: 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. 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: Severe lung, heart, liver, kidney and other diseases; Combined endocrine diseases (polycystic ovary syndrome, hypothyroidism, Cushing syndrome, etc.); Have a history of surgery to lose weight; have a history of adhesions after previous surgery; 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; Women during pregnancy, lactation and menopause; 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Electroacupuncture combined with umbilical moxibustion<br> | Behavioral: Electroacupuncture combined with umbilical moxibustion<br>* ①Umbilical moxibustion intervention: point selection: Shenque point Operation: Place the aconite cake on the Shenque point, place the Aizhu in the middle of the aconite cake, ignite the Aizhu and apply moxibustion to make the local warm sensation without burning pain, until the skin is flushed. ②Electro-acupuncture intervention: Acupoint selection: Tianshu, Zusanli, Zhongwan, Moisture, Daheng, Vein, Waterway, Huaroumen, Abdominal Knot. Operation: supine position, routine skin disinfection. After routine acupuncture at the acupoints, apply the technique of flattening, replenishing, relieving, and relieving qi. Tianshu and Daheng points, respectively, were horizontally connected to the electrodes of the electroacupuncture instrument on the needle handles of the bilateral Tianshu and Daheng points. Electroacupuncture parameters: density wave, current intensity 1-5mA, electroacupuncture intensity is subject to patient tolerance.<br>|
| Active Comparator: Electroacupuncture<br> | Behavioral: Electroacupuncture<br>* ②Electro-acupuncture intervention: Acupoint selection: Tianshu, Zusanli, Zhongwan, Moisture, Daheng, Vein, Waterway, Huaroumen, Abdominal Knot. Operation: supine position, routine skin disinfection. After routine acupuncture at the acupoints, apply the technique of flattening, replenishing, relieving, and relieving qi. Tianshu and Daheng points, respectively, were horizontally connected to the electrodes of the electroacupuncture instrument on the needle handles of the bilateral Tianshu and Daheng points. Electroacupuncture parameters: density wave, current intensity 1-5mA, electroacupuncture intensity is subject to patient tolerance.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline Waist circumference(WC) at week 12 | The horizontal girth through the center of the umbilicus | Baseline and Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight(WG) | Weight(WG) will be measured. | Week 0, Week 4, Week 8, Week 12 | 
| BMI(weight/(height) | BMI (weight/(height) will be measured. | Week 0, Week 4, Week 8, Week 12 | 
| hip circumference(HC) | hip circumference(HC) will be measured. | Week 0, Week 4, Week 8, Week 12 | 
| Waist-to-hip ratio(waist circumference/hip circumference) | waist-to-hip ratio(waist circumference/hip circumference) will be measured. | Week 0, Week 4, Week 8, Week 12 | 
| The impact of weight on quality of life (IWQOL)-Lite scale | 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. | Week 0, Week 4, Week 8, Week 12 | 
| The 10-item Kessler Psychological Distress (K10) Scale | 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. | Week 0, Week 4, Week 8, Week 12 | 
| TCM Physique Classification and Judgment Table | 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. | Week 0, Week 4, Week 8, Week 12 | 
| Serum cortisol (FC) | Serum cortisol (FC) will be measured to assist in reflecting changes in participants' Yang deficiency constitution. | Week 0, Week 8 | 
| Serum corticosterone (CORT) | Serum corticosterone (CORT) will be measured to assist in reflecting changes in participants' Yang deficiency constitution. | Week 0, Week 8 | 
| Serum adrenocorticotropic hormone (ACTH) | Serum adrenocorticotropic hormone (ACTH) will be measured to assist in reflecting changes in participants' Yang deficiency constitution. | Week 0, Week 8 |