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Electroacupuncture Combined With Umbilical Moxibustion on Abdominal Obesity of Yang Deficiency

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ClinicalTrials.gov Identifier: NCT04835181
Recruitment Status : Not yet recruiting
First Posted : April 8, 2021
Last Update Posted : April 8, 2021
Sponsor:
Information provided by (Responsible Party):
Hubei Hospital of Traditional Chinese Medicine

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.

Condition or disease Intervention/treatment Phase
Obesity, Abdominal Behavioral: Electroacupuncture combined with umbilical moxibustion Behavioral: Electroacupuncture Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Electroacupuncture Combined With Umbilical Moxibustion on Abdominal Obesity of Yang Deficiency: A Study Protocol for a Randomized Controlled Trial
Estimated Study Start Date : April 1, 2021
Estimated Primary Completion Date : December 1, 2021
Estimated Study Completion Date : January 31, 2022

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.





Primary Outcome Measures :
  1. Change from baseline Waist circumference(WC) at week 12 [ Time Frame: Baseline and Week 12 ]
    The horizontal girth through the center of the umbilicus


Secondary Outcome Measures :
  1. Weight(WG) [ Time Frame: Week 0, Week 4, Week 8, Week 12 ]
    Weight(WG) will be measured.

  2. BMI(weight/(height) [ Time Frame: Week 0, Week 4, Week 8, Week 12 ]
    BMI (weight/(height) will be measured.

  3. hip circumference(HC) [ Time Frame: Week 0, Week 4, Week 8, Week 12 ]
    hip circumference(HC) will be measured.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04835181


Contacts
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Contact: Kou Xu, MM +8613667248326 1932707307@stmail.hbtcm.edu.cn

Sponsors and Collaborators
Hubei Hospital of Traditional Chinese Medicine
Investigators
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Principal Investigator: Zhong-Yu Zhou, MD Hubei Hospital of Traditional Chinese Medicine
Publications:

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Responsible Party: Hubei Hospital of Traditional Chinese Medicine
ClinicalTrials.gov Identifier: NCT04835181    
Other Study ID Numbers: HBPCIC-2020-05
First Posted: April 8, 2021    Key Record Dates
Last Update Posted: April 8, 2021
Last Verified: February 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Obesity
Obesity, Abdominal
Yang Deficiency
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Pathologic Processes