Electroacupuncture Combined With Umbilical Moxibustion on Abdominal Obesity of Yang Deficiency

April 5, 2021 updated by: Hubei Hospital of Traditional Chinese Medicine

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

68

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Electroacupuncture combined with umbilical moxibustion
Behavioral: Electroacupuncture combined with umbilical moxibustion

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.
ACTIVE_COMPARATOR: Electroacupuncture
Behavioral: Electroacupuncture

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline Waist circumference(WC) at week 12
Time Frame: Baseline and 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)
Time Frame: Week 0, Week 4, Week 8, Week 12
Weight(WG) will be measured.
Week 0, Week 4, Week 8, Week 12
BMI(weight/(height)
Time Frame: Week 0, Week 4, Week 8, Week 12
BMI (weight/(height) will be measured.
Week 0, Week 4, Week 8, Week 12
hip circumference(HC)
Time Frame: Week 0, Week 4, Week 8, Week 12
hip circumference(HC) will be measured.
Week 0, Week 4, Week 8, Week 12
Waist-to-hip ratio(waist circumference/hip circumference)
Time Frame: Week 0, Week 4, Week 8, Week 12
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
Time Frame: 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.
Week 0, Week 4, Week 8, Week 12
The 10-item Kessler Psychological Distress (K10) Scale
Time Frame: 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.
Week 0, Week 4, Week 8, Week 12
TCM Physique Classification and Judgment Table
Time Frame: 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.
Week 0, Week 4, Week 8, Week 12
Serum cortisol (FC)
Time Frame: Week 0, Week 8
Serum cortisol (FC) will be measured to assist in reflecting changes in participants' Yang deficiency constitution.
Week 0, Week 8
Serum corticosterone (CORT)
Time Frame: Week 0, Week 8
Serum corticosterone (CORT) will be measured to assist in reflecting changes in participants' Yang deficiency constitution.
Week 0, Week 8
Serum adrenocorticotropic hormone (ACTH)
Time Frame: Week 0, Week 8
Serum adrenocorticotropic hormone (ACTH) will be measured to assist in reflecting changes in participants' Yang deficiency constitution.
Week 0, Week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hubei Hospital of Traditional Chinese Medicine

Investigators

  • Principal Investigator: Zhong-Yu Zhou, MD, Hubei Hospital of Traditional Chinese Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

April 1, 2021

Primary Completion (ANTICIPATED)

December 1, 2021

Study Completion (ANTICIPATED)

January 31, 2022

Study Registration Dates

First Submitted

March 31, 2021

First Submitted That Met QC Criteria

April 5, 2021

First Posted (ACTUAL)

April 8, 2021

Study Record Updates

Last Update Posted (ACTUAL)

April 8, 2021

Last Update Submitted That Met QC Criteria

April 5, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HBPCIC-2020-05

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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