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Obesity, AbdominalNCT04835181

Electroacupuncture Combined With Umbilical Moxibustion on Abdominal Obesity of Yang Deficiency

A study testing Electroacupuncture combined with umbilical moxibustion and Electroacupuncture in people with Obesity, Abdominal, run by Hubei Hospital of Traditional Chinese Medicine.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 55 years
Conditions the study is for
Obesity, Abdominal
What is being tested?
Electroacupuncture combined with umbilical moxibustion and Electroacupuncture
Could I receive a placebo?
No, everyone receives an active treatment
How many people
68 participants
Where
No sites listed yet
Study dates
1 Apr 2021to 31 Jan 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

No sites are listed yet.

About this study

Official title: 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.

Being tested
Electroacupuncture combined with umbilical moxibustion, Electroacupuncture
Medical subject headings
Obesity, Abdominal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Electroacupuncture combined with umbilical moxibustionBehavioural

    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.

  • ElectroacupunctureBehavioural

    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.

Study groups in NCT04835181
Study groupRoleWhat they receive
Electroacupuncture combined with umbilical moxibustionExperimentalNot described
Receives: Behavioral: Electroacupuncture combined with umbilical moxibustion
ElectroacupunctureActive comparatorNot described
Receives: Behavioral: Electroacupuncture

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline Waist circumference(WC) at week 12

    The horizontal girth through the center of the umbilicus

    Measured: Baseline and Week 12

Secondary outcomes (10)
  1. Weight(WG)

    Weight(WG) will be measured.

    Measured: Week 0, Week 4, Week 8, Week 12

  2. BMI(weight/(height)

    BMI (weight/(height) will be measured.

    Measured: Week 0, Week 4, Week 8, Week 12

  3. hip circumference(HC)

    hip circumference(HC) will be measured.

    Measured: Week 0, Week 4, Week 8, Week 12

  4. Waist-to-hip ratio(waist circumference/hip circumference)

    waist-to-hip ratio(waist circumference/hip circumference) will be measured.

    Measured: Week 0, Week 4, Week 8, Week 12

  5. 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.

    Measured: Week 0, Week 4, Week 8, Week 12

  6. 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.

    Measured: Week 0, Week 4, Week 8, Week 12

  7. 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.

    Measured: Week 0, Week 4, Week 8, Week 12

  8. Serum cortisol (FC)

    Serum cortisol (FC) will be measured to assist in reflecting changes in participants' Yang deficiency constitution.

    Measured: Week 0, Week 8

  9. Serum corticosterone (CORT)

    Serum corticosterone (CORT) will be measured to assist in reflecting changes in participants' Yang deficiency constitution.

    Measured: Week 0, Week 8

  10. Serum adrenocorticotropic hormone (ACTH)

    Serum adrenocorticotropic hormone (ACTH) will be measured to assist in reflecting changes in participants' Yang deficiency constitution.

    Measured: Week 0, Week 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Apr 2021
  2. Study start1 Apr 2021 (estimated)
  3. Primary completion1 Dec 2021 (estimated)
  4. Study completion31 Jan 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
68 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04835181
Sponsor's protocol ID
HBPCIC-2020-05
Status last verified
Feb 2021
First submitted
31 Mar 2021
Last updated
8 Apr 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Park BY, Lee MJ, Kim M, Kim SH, Park H. Structural and Functional Brain Connectivity Changes Between People With Abdominal and Non-abdominal Obesity and Their Association With Behaviors of Eating Disorders. Front Neurosci. 2018 Oct 11;12:741. doi: 10.3389/fnins.2018.00741. eCollection 2018.

    PubMed 30364290
  • Yusuf S, Hawken S, Ounpuu S, Dans T, Avezum A, Lanas F, McQueen M, Budaj A, Pais P, Varigos J, Lisheng L; INTERHEART Study Investigators. Effect of potentially modifiable risk factors associated with myocardial infarction in 52 countries (the INTERHEART study): case-control study. Lancet. 2004 Sep 11-17;364(9438):937-52. doi: 10.1016/S0140-6736(04)17018-9.

    PubMed 15364185
  • Freisling H, Arnold M, Soerjomataram I, O'Doherty MG, Ordonez-Mena JM, Bamia C, Kampman E, Leitzmann M, Romieu I, Kee F, Tsilidis K, Tjonneland A, Trichopoulou A, Boffetta P, Benetou V, Bueno-de-Mesquita HBA, Huerta JM, Brenner H, Wilsgaard T, Jenab M. Comparison of general obesity and measures of body fat distribution in older adults in relation to cancer risk: meta-analysis of individual participant data of seven prospective cohorts in Europe. Br J Cancer. 2017 May 23;116(11):1486-1497. doi: 10.1038/bjc.2017.106. Epub 2017 Apr 25.

    PubMed 28441380
  • Garvey WT, Mechanick JI, Brett EM, Garber AJ, Hurley DL, Jastreboff AM, Nadolsky K, Pessah-Pollack R, Plodkowski R; Reviewers of the AACE/ACE Obesity Clinical Practice Guidelines. AMERICAN ASSOCIATION OF CLINICAL ENDOCRINOLOGISTS AND AMERICAN COLLEGE OF ENDOCRINOLOGY COMPREHENSIVE CLINICAL PRACTICE GUIDELINES FOR MEDICAL CARE OF PATIENTS WITH OBESITY. Endocr Pract. 2016 Jul;22 Suppl 3:1-203. doi: 10.4158/EP161365.GL. Epub 2016 May 24.

    PubMed 27219496
  • Dalle Grave R, Calugi S, El Ghoch M. Lifestyle modification in the management of obesity: achievements and challenges. Eat Weight Disord. 2013 Dec;18(4):339-49. doi: 10.1007/s40519-013-0049-4. Epub 2013 Jul 27.

    PubMed 23893662
  • Khera R, Murad MH, Chandar AK, Dulai PS, Wang Z, Prokop LJ, Loomba R, Camilleri M, Singh S. Association of Pharmacological Treatments for Obesity With Weight Loss and Adverse Events: A Systematic Review and Meta-analysis. JAMA. 2016 Jun 14;315(22):2424-34. doi: 10.1001/jama.2016.7602.

    PubMed 27299618
  • Gloy VL, Briel M, Bhatt DL, Kashyap SR, Schauer PR, Mingrone G, Bucher HC, Nordmann AJ. Bariatric surgery versus non-surgical treatment for obesity: a systematic review and meta-analysis of randomised controlled trials. BMJ. 2013 Oct 22;347:f5934. doi: 10.1136/bmj.f5934.

    PubMed 24149519
  • Andersen CJ, Murphy KE, Fernandez ML. Impact of Obesity and Metabolic Syndrome on Immunity. Adv Nutr. 2016 Jan 15;7(1):66-75. doi: 10.3945/an.115.010207. Print 2016 Jan.

    PubMed 26773015
  • Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, Zhang L, Fan G, Xu J, Gu X, Cheng Z, Yu T, Xia J, Wei Y, Wu W, Xie X, Yin W, Li H, Liu M, Xiao Y, Gao H, Guo L, Xie J, Wang G, Jiang R, Gao Z, Jin Q, Wang J, Cao B. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020 Feb 15;395(10223):497-506. doi: 10.1016/S0140-6736(20)30183-5. Epub 2020 Jan 24.

    PubMed 31986264
  • Sheng J, Jin X, Zhu J, Chen Y, Liu X. The Effectiveness of Acupoint Catgut Embedding Therapy for Abdominal Obesity: A Systematic Review and Meta-Analysis. Evid Based Complement Alternat Med. 2019 Jun 23;2019:9714313. doi: 10.1155/2019/9714313. eCollection 2019.

    PubMed 31341504

Questions about this trial

What is this clinical trial studying?

A study testing Electroacupuncture combined with umbilical moxibustion and Electroacupuncture in people with Obesity, Abdominal, run by Hubei Hospital of Traditional Chinese Medicine.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 8 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Kou Xu, MM (+8613667248326, 1932707307@stmail.hbtcm.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline Waist circumference(WC) at week 12 (time frame: Baseline and Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04835181, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2021.

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