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Completed

NCT Number: NCT05023148

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

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cipto Mangunkusumo Hospital

Jakarta, DKI Jakarta, 10430, Indonesia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

electroacupuncture

Procedure

Stimulating acupoints using electric stimulator

Thread embedded acupuncture

Procedure

Stimulating acupoints using thread embedded

Primary outcomes

  1. Body weight

    Time frame: 1 month

    Participants' body weight in kilograms

  2. Waist circumference

    Time frame: 1 month

    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

  3. Leptin level

    Time frame: 1 month

    Plasma leptin examination using ELISA method

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Registry information

Official study title

Comparison Therapeutic Effects Between Electroacupuncture and Thread Embedded Acupuncture in Obese Patients With Dietary Intervention

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Aug 26, 2021
Registry last updated
Jan 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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