CClinicalTrials.gg
CompletedNCT05023148Updated Jan 27, 2022

Comparison of Electroacupuncture and Thread Embedded Acupuncture With Dietary Intervention in Obese Patients

An interventional study of Electroacupuncture and Thread embedded acupuncture in Obesity, sponsored by Indonesia University. Completed at 1 site in Indonesia. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-01-27.

Sponsored by Indonesia University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
34
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study summary

The purpose of this study is to compare the effectiveness between electroacupuncture treatment with dietary intervention and thread embedded acupuncture with dietary intervention in reducing body weight, waist circumference, and leptin level in obese patients.

Read the detailed description

The purpose of this study is to describe reducement in body weight, waist circumference, and leptin level in obese patients with dietary intervention and electroacupuncture or dietary intervention with thread embedded acupuncture. It is also to analyze mean differences of body weight, waist circumference, and leptin level in obese patients between the two interventions. The results of the study expected to be used as an operating standard procedure for obese patients.

02

Conditions studied

  • Obesity

Keywords

  • electroacupuncture
  • thread embedded acupuncture
  • obese
  • dietary intervention
03

In context

Lead sponsor

Indonesia University is the lead sponsor of 448 studies on the registry; 56 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Age 18 - 60 years
  • Obese with Body Mass Index (BMI) 25 - 35 kg/m\^2
  • Waist circumference male > 90 cm and female > 80 cm
  • Willing to participate in the study by signing an informed consent
  • Willing to follow the study process until it is finished

Exclusion criteria

Exclusion Criteria:

  • Pregnancy
  • Post partum \< 6 months
  • Diabetes (Blood glucose POCT (Point of Care Testing) >= 200 mg/dl)
  • Hypertension (Blood pressure >= 140/90 mmHg)
  • Fever > 38\^C
  • Has a history of contraindication for electroacupuncture such as history of heart diseases, pace maker, arrhythmia
  • Has a history of contraindication for thread embedded acupuncture such as allergy of PDO (Polydioxanone), blood clotting disorder, consumption of anticoagulant drugs, local infection or wound on embedded site
  • Has a history of weight loss drugs consumption (such as orlistat, phentermine, diethylpropion) or slimming supplements (green tea, jati belanda/Guazuma ulmifolia) for the last 25 hours.
  • History of liver disease, kidney disease
  • Has had acupuncture therapy for obesity in the last six months
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
34 participants (actual)

Study arms

  • Active comparator
    Electroacupuncture with dietary intervention

    Acupoints stimulation with an electric stimulator on CV12 Zhongwan, CV9 Shuifen, CV6 Qihai, CV4 Guanyuan, ST25 Tianshu bilateral, SP15 Daheng bilateral, ST40 Fenglong bilateral using continuous 2 Hz for 30 minutes. Therapy sessions are three times a week for four weeks (total 12 times). Dietary intervention means reducing 500 calories from usual calorie consumptions and will be done twice, at the beginning and 2 weeks after.

    Procedure: Electroacupuncture

  • Active comparator
    Thread embedded acupuncture with dietary intervention

    Acupoints stimulation by embedding PDO thread in CV12 Zhongwan penetrating to CV9 Shuifen using 27G x 60 mm, CV4 Guanyuan penetrating to CV6 Qihai using 27G x 40 mm, ST25 Tianshu penetrating to SP15 Daheng using 27G x 40 mm, and perpendicular in ST40 Fenglong bilateral using 31G x 25 mm. Therapy will be done only once. Dietary intervention means reducing 500 calories from usual calorie consumptions and will be done twice, at the beginning and 2 weeks after.

    Procedure: Thread embedded acupuncture

Interventions

  • ProcedureElectroacupuncture

    Stimulating acupoints using electric stimulator

  • ProcedureThread embedded acupuncture

    Stimulating acupoints using thread embedded

06

What researchers measure

Primary outcomes

  1. Body weight

    Participants' body weight in kilograms

    Time frame: 1 month

  2. Waist circumference

    Waist circumference is measured at the end of several consecutive natural breaths, at the level parallel to the floor, midpoint between the top of the iliac crest and the lower margin of the last palpable rib in the midaxillary line

    Time frame: 1 month

  3. Leptin level

    Plasma leptin examination using ELISA method

    Time frame: 1 month

07

Study locations

1 site
  • Cipto Mangunkusumo Hospital
    Jakarta, DKI Jakarta 10430, Indonesia
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 27, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05023148
Lead sponsor
Indonesia University
Responsible party
Cindy Notonegoro (Principal Investigator, Indonesia University) — Principal investigator
First posted
Aug 26, 2021
Start date
Jul 21, 2021
Primary completion
Oct 26, 2021
Completion
Oct 26, 2021
Last update
Jan 27, 2022

Study contacts

Cindy Notonegoro, dr.
principal investigator · Faculty of Medicine, University of Indonesia

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion