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Thread Embedding Acupuncture Combined With Auricular Acupuncture for Overweight and Obesity

Primary Purpose

Overweight or Obesity

Status

Recruiting

Phase

Not Applicable

Locations

Vietnam

Study Type

Interventional

Intervention

Auricular acupuncture

Thread embedding acupuncture

Sham Thread embedding acupuncture

About this trial

This is an interventional treatment trial for Overweight or Obesity focused on measuring overweight, obesity, auricular acupuncture, thread embedding acupuncture, traditional medicine

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Simple overweight or obesity with a Body Mass Index (BMI) of 23 kg/m2 or higher, following the criteria of The World Health Organization Regional Office for the Western Pacific Region. Waist circumference of 90 cm or more for males, or 80 cm or more for females. Voluntary informed consent. Exclusion Criteria: Secondary obesity resulting from endocrine diseases or medication. Presence of severe medical conditions (e.g., cardiovascular, hepatic, renal or others) that could potentially affect treatment outcomes as per researchers' assessments. Current use of weight-affecting medications, including diabetes medications, endocrine medications, and medications for neurological psychiatric disorders. Pregnancy, lactation, or recent childbirth within the past 6 months. Severe mental and neurological conditions that may impact treatment compliance. Alcohol or substance addiction. History of hypersensitivity reactions to any form of acupuncture with needles or to Polydioxanone. Existing injuries or lesions at the acupoints under investigation in this study. Concurrent participation in other clinical trials or utilization of other weight reduction therapies.

Sites / Locations

University of Medical Center HCMC - Branch no.3Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

AA + TEA

AA + Sham-TEA

Arm Description

Auricular acupuncture (AA) every week in eight weeks (eight sessions). Combined with Thread embedding acupuncture (TEA) every two weeks in eight weeks (four sessions).

Auricular acupuncture (AA) every week in eight weeks (eight sessions). Combined with Sham Thread embedding acupuncture (Sham-TEA) every two weeks in eight weeks (four sessions).

Outcomes

Primary Outcome Measures

Changes in body weight

The body weight of the participants will be collected by investigators in the morning after the participants' personal hygiene routine and before breakfast, with measurements in kilograms (kg).

Secondary Outcome Measures

Changes in Body Mass Index (BMI)

BMI will be calculated with the Quetelet index formula, with units in kg/m².

Changes in waist circumference

The waist circumference of the participants will be measured by investigators in the morning after the participants' personal hygiene routine and before breakfast, with units in centimeters (cm). The waist circumference measurements will be conducted in accordance with the protocol established by the World Health Organization.

Changes in hip circumference

The hip circumference of the participants will be measured by investigators in the morning after the participants' personal hygiene routine and before breakfast, with units in centimeters (cm). The hip circumference measurements will be conducted in accordance with the protocol established by the World Health Organization.

Changes in waist-hip ratio

The waist-hip ratio will be calculated by dividing the waist circumference(cm) by the hip circumference(cm).

Changes in the Food Cravings Questionnaire-Trait-reduced (FCQ-T-r) score

The FCQ-T-r consists of 15 items. Participants will be requested to express their agreement using a Likert-type scale that ranges from 1 = "strongly disagree" to 5 = "strongly agree", allowing for total scores within the range of 15 to 75, with higher scores indicating greater appetite.

Changes in Visual Analog Scale (VAS) score for appetite

The VAS consists of a 100mm long line with two endpoints, ranging from "no appetite" to "greatest appetite ever experienced." Participants will mark the position on the scale that corresponds to their current appetite sensation.

Proportion of intervention-related adverse effects

Expected adverse events (AEs) for Auricular acupuncture include pain at the insertion site, local discomfort, local skin irritation (itching and redness), local inflammation and bleeding, chondritis, dizziness, nausea, and hypersensitivity reactions. For Thread embedding acupuncture, expected AEs encompass local discomfort, post-treatment elevation in body temperature, local hematoma or subcutaneous hemorrhage, local swelling, local induration, local pain, local redness, infection, abscess, pruritus, and anaphylaxis. Additionally, any unexpected AEs associated with these procedures will also be documented and monitored.

Full Information

NCT ID

NCT06091761

First Posted

October 12, 2023

Last Updated

October 18, 2023

Sponsor

University of Medicine and Pharmacy at Ho Chi Minh City

1. Study Identification

Unique Protocol Identification Number

NCT06091761

Brief Title

Thread Embedding Acupuncture Combined With Auricular Acupuncture for Overweight and Obesity

Official Title

Efficacy and Safety of Thread Embedding Acupuncture Combined With Auricular Acupuncture for Overweight and Obesity: Randomized Placebo-Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Recruiting

Study Start Date

October 30, 2023 (Anticipated)

Primary Completion Date

April 30, 2024 (Anticipated)

Study Completion Date

April 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Medicine and Pharmacy at Ho Chi Minh City

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

Overweight and obesity are chronic non-communicable diseases with a rapidly increasing global prevalence. They constitute risk factors for various chronic conditions, including cardiovascular diseases, type 2 diabetes, chronic kidney disease, cancer, as well as musculoskeletal disorders and numerous other disorders, significantly impacting the quality of life. Numerous non-pharmacological interventions have been employed in the management of these conditions. Particularly, Auricular acupuncture (AA) has been a widely used and established method for weight management, owing to its effectiveness, safety, and convenience. Recently, a novel therapy known as Thread embedding acupuncture (TEA) has also demonstrated efficacy in weight reduction. Several studies have shown a substantial increase in treatment effectiveness when combining TEA with other acupuncture therapies. However, there is currently no available data on the combination of TEA with AA. This study is conducted to assess the efficacy and safety of combining TEA with AA compared with AA monotherapy in overweight and obesity.

Detailed Description

Eligible participants with overweight or obesity, defined according to the criteria set by The World Health Organization Regional Office for the Western Pacific Region (Body Mass Index [BMI] of 23 kg/m² or higher), will be enrolled and subsequently randomized into two groups: the intervention group (AA + TEA group) and the placebo group (AA + Sham-TEA group), with a 1:1 allocation ratio. In both groups, the intervention duration is eight weeks, with Auricular acupuncture (AA) administered weekly, along with recommended lifestyle modifications. For the intervention group, Thread embedding acupuncture (TEA) therapy will be added every two weeks, totaling four sessions during the eight-week period. Meanwhile, Sham-TEA will be administered in the placebo group. Data regarding body weight, BMI, waist circumference, hip circumference, appetite, and adverse effects will be recorded immediately following randomization and weekly thereafter over the eight-week duration.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Overweight or Obesity

Keywords

overweight, obesity, auricular acupuncture, thread embedding acupuncture, traditional medicine

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Masking Description

Participants will be unaware of their random allocation into either the intervention or placebo group. Sham Thread embedding acupuncture (Sham-TEA) will be administered in a manner similar to TEA, but without the insertion of threads, ensuring that no threads are left at the acupoints after the procedure. The physician responsible for administering the treatments will be aware of the group assignments but remain uninvolved in the evaluation of outcomes and subsequent data analysis. Those responsible for outcome assessment and data analysis will be kept blinded to the treatment assignments.

Allocation

Randomized

Enrollment

66 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

AA + TEA

Arm Type

Experimental

Arm Description

Auricular acupuncture (AA) every week in eight weeks (eight sessions). Combined with Thread embedding acupuncture (TEA) every two weeks in eight weeks (four sessions).

Arm Title

AA + Sham-TEA

Arm Type

Sham Comparator

Arm Description

Auricular acupuncture (AA) every week in eight weeks (eight sessions). Combined with Sham Thread embedding acupuncture (Sham-TEA) every two weeks in eight weeks (four sessions).

Intervention Type

Other

Intervention Name(s)

Auricular acupuncture

Intervention Description

Auricular acupuncture is conducted weekly in eight weeks using patches, each with a square shape and a side length of 10 mm, along with sterilized needles measuring 0.25 x 1.3 mm. Five acupoints on one ear are selected, which included Shen-men (TF4), Stomach (CO4), Spleen (CO13), Endocrine (CO18), and Hunger point. The patch with the needle will remain in place for one week.

Intervention Type

Other

Intervention Name(s)

Thread embedding acupuncture

Intervention Description

Thread embedding acupuncture is performed every two weeks in eight weeks using a single Polydioxaone thread. Needles has a gauge size of 29G, a shaft length of 38mm, and a thread length of 50mm, folded in half, and are applied to ten acupoints, including Qihai (CV6), Shuifen (CV9), and Tianshu (ST25), Shuidao (ST28), Daheng (SP15), Siman (KI14) on both sides of the body. Needles with a gauge size of 30G, a shaft length of 25mm, and a thread length of 30mm, folded in half, are used for five acupoints, which included Zhongwan (CV12) and Zusanli (ST36), Pishu (BL20) on both sides of the body. After the thread being inserted into the body, the needle will be withdrawn immediately.

Intervention Type

Other

Intervention Name(s)

Sham Thread embedding acupuncture

Intervention Description

Sham Thread embedding acupuncture is performed every two weeks in eight weeks. Needles without threads has a gauge size of 29G, and a shaft length of 38mm, are applied to ten acupoints, including Qihai (CV6), Shuifen (CV9), and Tianshu (ST25), Shuidao (ST28), Daheng (SP15), Siman (KI14) on both sides of the body. Needles without threads with a gauge size of 30G, and a shaft length of 25mm, are used for five acupoints, which included Zhongwan (CV12) and Zusanli (ST36), Pishu (BL20) on both sides of the body. After the needle being inserted into the body, it will be withdrawn immediately.

Primary Outcome Measure Information:

Title

Changes in body weight

Description

The body weight of the participants will be collected by investigators in the morning after the participants' personal hygiene routine and before breakfast, with measurements in kilograms (kg).

Time Frame

Assessments conducted at randomization and after each intervention week throughout the eight-week period (Week 0, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, and Week 8)

Secondary Outcome Measure Information:

Title

Changes in Body Mass Index (BMI)

Description

BMI will be calculated with the Quetelet index formula, with units in kg/m².

Time Frame

Assessments conducted at randomization and after each intervention week throughout the eight-week period (Week 0, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, and Week 8)

Title

Changes in waist circumference

Description

Time Frame

Assessments conducted at randomization and after each intervention week throughout the eight-week period (Week 0, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, and Week 8)

Title

Changes in hip circumference

Description

Time Frame

Assessments conducted at randomization and after each intervention week throughout the eight-week period (Week 0, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, and Week 8)

Title

Changes in waist-hip ratio

Description

The waist-hip ratio will be calculated by dividing the waist circumference(cm) by the hip circumference(cm).

Time Frame

Assessments conducted at randomization and after each intervention week throughout the eight-week period (Week 0, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, and Week 8)

Title

Changes in the Food Cravings Questionnaire-Trait-reduced (FCQ-T-r) score

Description

Time Frame

Assessments conducted at randomization and after each intervention week throughout the eight-week period (Week 0, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, and Week 8)

Title

Changes in Visual Analog Scale (VAS) score for appetite

Description

Time Frame

Assessments conducted at randomization and after each intervention week throughout the eight-week period (Week 0, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, and Week 8)

Title

Proportion of intervention-related adverse effects

Description

Time Frame

Up to eight weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Facility Information:

Facility Name

University of Medical Center HCMC - Branch no.3

City

Ho Chi Minh

ZIP/Postal Code

700000

Country

Vietnam

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Viet Quoc Kieu, medical doctor

Phone

+84971311068

kqviet.ntyhct21@ump.edu.vn

First Name & Middle Initial & Last Name & Degree

Minh-Man Pham Bui, medical doctor

Phone

+84916080803

bpmman@ump.edu.vn

12. IPD Sharing Statement

Citations:

PubMed Identifier

31929817

Citation

Lillingston F, Fields P, Waechter R. Auricular Acupuncture Associated with Reduced Waist Circumference in Overweight Women-A Randomized Controlled Trial. Evid Based Complement Alternat Med. 2019 Dec 18;2019:6471560. doi: 10.1155/2019/6471560. eCollection 2019.

Results Reference

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PubMed Identifier

29772131

Citation

Yasemin C, Turan S, Kosan Z. The Effects of Auricular and Body Acupuncture in Turkish Obese Female Patients: A Randomized Controlled Trial Indicated Both Methods Lost Body Weight But Auricular Acupuncture Was Better Than Body Acupuncture. Acupunct Electrother Res. 2017 Jan;42(1):1-10. doi: 10.3727/036012917x14908026364990.

Results Reference

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PubMed Identifier

31341504

Citation

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.

Results Reference

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PubMed Identifier

35656457

Citation

Wang ZY, Li XY, Gou XJ, Chen CL, Li ZY, Zhao C, Huo WG, Guo YH, Yang Y, Liu ZD. Network Meta-Analysis of Acupoint Catgut Embedding in Treatment of Simple Obesity. Evid Based Complement Alternat Med. 2022 May 23;2022:6408073. doi: 10.1155/2022/6408073. eCollection 2022.

Results Reference

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PubMed Identifier

36595747

Citation

Zhao HY, Kim S, Son MJ. Comparing acupoint catgut embedding and acupuncture therapies for simple obesity: A protocol for systematic review and meta-analysis. Medicine (Baltimore). 2022 Dec 23;101(51):e31531. doi: 10.1097/MD.0000000000031531.

Results Reference

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PubMed Identifier

23212565

Citation

Yan RH, Liu XM, Bai J, Hou BB, Yu J, Gu JS. Clinical efficacy of simple obesity treated by catgut implantation at acupoints. Chin J Integr Med. 2015 Aug;21(8):594-600. doi: 10.1007/s11655-012-1215-7. Epub 2012 Dec 3.

Results Reference

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PubMed Identifier

36378041

Citation

Wujie YE, Jingyu X, Zekai YU, Xingang HU, Yan Z. Systematic review and Meta-analysis of acupuncture and acupoint catgut embedding for the treatment of abdominal obesity. J Tradit Chin Med. 2022 Dec;42(6):848-857. doi: 10.19852/j.cnki.jtcm.2022.06.002.

Results Reference

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PubMed Identifier

35265146

Citation

Chen X, Huang W, Wei D, Zhao JP, Zhang W, Ding DG, Jiao Y, Pan HL, Zhang JJ, Zhong F, Gao F, Jin YT, Zheng YW, Zhang YJ, Huang Q, Zeng XT, Zhou ZY. Effect of Acupoint Catgut Embedding for Middle-Aged Obesity: A Multicentre, Randomised, Sham-Controlled Trial. Evid Based Complement Alternat Med. 2022 Feb 27;2022:4780019. doi: 10.1155/2022/4780019. eCollection 2022.

Results Reference

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PubMed Identifier

36378040

Citation

Jiali W, Lily L, Zhechao L, Jianping L, Mei H. Acupoint catgut embedding versus acupuncture for simple obesity: a systematic review and Meta-analysis of randomized controlled trials. J Tradit Chin Med. 2022 Dec;42(6):839-847. doi: 10.19852/j.cnki.jtcm.2022.06.001.

Results Reference

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PubMed Identifier

35966092

Citation

Dai L, Wang M, Zhang KP, Wang L, Zheng HM, Li CB, Zhou WJ, Zhou SG, Ji G. Modified acupuncture therapy, long-term acupoint stimulation versus sham control for weight control: a multicenter, randomized controlled trial. Front Endocrinol (Lausanne). 2022 Jul 28;13:952373. doi: 10.3389/fendo.2022.952373. eCollection 2022.

Results Reference

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Links:

URL

https://www.who.int/publications/i/item/9789241501491

Description

Related Info

URL

https://iris.who.int/handle/10665/206936?locale-attribute=es&show=full

Description

Related Info

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Thread Embedding Acupuncture Combined With Auricular Acupuncture for Overweight and Obesity

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