Electroacupuncture Combined With Umbilical Moxibustion on Abdominal Obesity of Yang Deficiency
Primary Purpose
Obesity, Abdominal
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Electroacupuncture combined with umbilical moxibustion
Electroacupuncture
Sponsored by
About this trial
This is an interventional treatment trial for Obesity, Abdominal
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Electroacupuncture combined with umbilical moxibustion
Electroacupuncture
Arm Description
Outcomes
Primary Outcome Measures
Change from baseline Waist circumference(WC) at week 12
The horizontal girth through the center of the umbilicus
Secondary Outcome Measures
Weight(WG)
Weight(WG) will be measured.
BMI(weight/(height)
BMI (weight/(height) will be measured.
hip circumference(HC)
hip circumference(HC) will be measured.
Waist-to-hip ratio(waist circumference/hip circumference)
waist-to-hip ratio(waist circumference/hip circumference) will be measured.
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.
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.
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.
Serum cortisol (FC)
Serum cortisol (FC) will be measured to assist in reflecting changes in participants' Yang deficiency constitution.
Serum corticosterone (CORT)
Serum corticosterone (CORT) will be measured to assist in reflecting changes in participants' Yang deficiency constitution.
Serum adrenocorticotropic hormone (ACTH)
Serum adrenocorticotropic hormone (ACTH) will be measured to assist in reflecting changes in participants' Yang deficiency constitution.
Full Information
NCT ID
NCT04835181
First Posted
March 31, 2021
Last Updated
April 5, 2021
Sponsor
Hubei Hospital of Traditional Chinese Medicine
1. Study Identification
Unique Protocol Identification Number
NCT04835181
Brief Title
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
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2021 (Anticipated)
Primary Completion Date
December 1, 2021 (Anticipated)
Study Completion Date
January 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hubei Hospital of Traditional Chinese Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Abdominal
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
68 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Electroacupuncture combined with umbilical moxibustion
Arm Type
Experimental
Arm Title
Electroacupuncture
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Electroacupuncture combined with umbilical moxibustion
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Electroacupuncture
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline Waist circumference(WC) at week 12
Description
The horizontal girth through the center of the umbilicus
Time Frame
Baseline and Week 12
Secondary Outcome Measure Information:
Title
Weight(WG)
Description
Weight(WG) will be measured.
Time Frame
Week 0, Week 4, Week 8, Week 12
Title
BMI(weight/(height)
Description
BMI (weight/(height) will be measured.
Time Frame
Week 0, Week 4, Week 8, Week 12
Title
hip circumference(HC)
Description
hip circumference(HC) will be measured.
Time Frame
Week 0, Week 4, Week 8, Week 12
Title
Waist-to-hip ratio(waist circumference/hip circumference)
Description
waist-to-hip ratio(waist circumference/hip circumference) will be measured.
Time Frame
Week 0, Week 4, Week 8, Week 12
Title
The impact of weight on quality of life (IWQOL)-Lite scale
Description
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.
Time Frame
Week 0, Week 4, Week 8, Week 12
Title
The 10-item Kessler Psychological Distress (K10) Scale
Description
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.
Time Frame
Week 0, Week 4, Week 8, Week 12
Title
TCM Physique Classification and Judgment Table
Description
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.
Time Frame
Week 0, Week 4, Week 8, Week 12
Title
Serum cortisol (FC)
Description
Serum cortisol (FC) will be measured to assist in reflecting changes in participants' Yang deficiency constitution.
Time Frame
Week 0, Week 8
Title
Serum corticosterone (CORT)
Description
Serum corticosterone (CORT) will be measured to assist in reflecting changes in participants' Yang deficiency constitution.
Time Frame
Week 0, Week 8
Title
Serum adrenocorticotropic hormone (ACTH)
Description
Serum adrenocorticotropic hormone (ACTH) will be measured to assist in reflecting changes in participants' Yang deficiency constitution.
Time Frame
Week 0, Week 8
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kou Xu, MM
Phone
+8613667248326
Email
1932707307@stmail.hbtcm.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhong-Yu Zhou, MD
Organizational Affiliation
Hubei Hospital of Traditional Chinese Medicine
Official's Role
Principal Investigator
12. IPD Sharing Statement
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Electroacupuncture Combined With Umbilical Moxibustion on Abdominal Obesity of Yang Deficiency
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