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Overweight or ObesityNCT06091761

Thread Embedding Acupuncture Combined With Auricular Acupuncture for Overweight and Obesity

A study testing Auricular acupuncture and Thread embedding acupuncture in people with Overweight or Obesity, run by University of Medicine and Pharmacy at Ho Chi Minh City at 1 site in Vietnam.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Overweight or Obesity
What is being tested?
Auricular acupuncture and Thread embedding acupuncture
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
66 participants
Where
1 siteVietnam
Study dates
30 Oct 2023to 21 Mar 2024
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 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 9Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Vietnam1 site

  • University of Medical Center HCMC - Branch no.3

    Ho Chi Minh City, 700000

Other trials in Vietnam

About this study

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

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.

Read the 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.

Being tested
Auricular acupuncture, Thread embedding acupuncture, Sham Thread embedding acupuncture
Keywords
overweight, obesity, auricular acupuncture, thread embedding acupuncture, traditional medicine
Medical subject headings
Overweight, Obesity

What participants receive

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

  • Auricular acupunctureOther

    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.

  • Thread embedding acupunctureOther

    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.

  • Sham Thread embedding acupunctureOther

    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.

Study groups in NCT06091761
Study groupRoleWhat they receive
AA + TEAExperimentalAuricular acupuncture (AA) every week in eight weeks (eight sessions). Combined with Thread embedding acupuncture (TEA) every two weeks in eight weeks (four sessions).
Receives: Other: Auricular acupuncture; Other: Thread embedding acupuncture
AA + Sham-TEASham comparatorAuricular 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).
Receives: Other: Auricular acupuncture; Other: Sham Thread embedding acupuncture

What is being measured

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

  1. 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).

    Measured: 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 outcomes (7)

  1. Changes in Body Mass Index (BMI)

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

    Measured: 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)

  2. 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.

    Measured: 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)

  3. 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.

    Measured: 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)

  4. Changes in waist-hip ratio

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

    Measured: 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)

  5. 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.

    Measured: 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)

  6. 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.

    Measured: 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)

  7. 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.

    Measured: Up to eight weeks

Timeline

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

  1. First posted19 Oct 2023
  2. Study start30 Oct 2023
  3. Primary completion21 Mar 2024
  4. Study completion21 Mar 2024

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
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
66 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06091761
Sponsor's protocol ID
700/HDDD-DHYD
Status last verified
Mar 2024
First submitted
12 Oct 2023
Last updated
22 Mar 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 31929817

  • 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.

    PubMed 29772131

  • 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

  • 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.

    PubMed 35656457

  • 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.

    PubMed 36595747

  • 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.

    PubMed 23212565

  • 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.

    PubMed 36378041

  • 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.

    PubMed 35265146

  • 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.

    PubMed 36378040

  • 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.

    PubMed 35966092

  • Trinh DT, Kieu QV, Tran AH, Bui MP, Vuong NL. Adding thread-embedding acupuncture to auricular acupuncture enhances short-term weight reduction in overweight and obesity: A double-blinded, randomized, sham-controlled trial. Integr Med Res. 2024 Sep;13(3):101050. doi: 10.1016/j.imr.2024.101050. Epub 2024 Jun 1.

    PubMed 38911552

Questions about this trial

What is this clinical trial studying?

A study testing Auricular acupuncture and Thread embedding acupuncture in people with Overweight or Obesity, run by University of Medicine and Pharmacy at Ho Chi Minh City at 1 site in Vietnam.

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 3 inclusion and 9 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: finished, as of the sponsor's last update on 22 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in body weight (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)). 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 NCT06091761, which also lists 11 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 22 Mar 2024.

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