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

Not Applicable

Completed

• Conditions: Obesity

• Registration Number: NCT05023148
• Lead Sponsor: Indonesia University

Brief 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.

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.

Study Timeline

• Study Start: 2021-07-21
• Study First Submitted: 2021-08-22
• Study First Submitted QC: 2021-08-24
• Study First Posted: 2021-08-26
• Primary Completion: 2021-10-26
• Study Completion: 2021-10-26
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-12
• Last Update Posted: 2022-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Body weight	1 month	Participants' body weight in kilograms
Waist circumference	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
Leptin level	1 month	Plasma leptin examination using ELISA method

Trial Locations

Locations (1)

Cipto Mangunkusumo Hospital; 🇮🇩 Jakarta, DKI Jakarta, Indonesia