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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
Hubei Hospital of Traditional Chinese Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity, Abdominal

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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.

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

    First Posted
    March 31, 2021
    Last Updated
    April 5, 2021
    Sponsor
    Hubei Hospital of Traditional Chinese Medicine
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    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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