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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05023148
• Other study ID #: 21-05-0530
• Status: Completed
• Phase: N/A
• Start date: July 21, 2021
• Est. completion date: October 26, 2021

Study information

• Verified date: January 2022
• Source: Indonesia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: October 26, 2021
• Est. primary completion date: October 26, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity

Intervention

Procedure:
• Electroacupuncture
Stimulating acupoints using electric stimulator
• Thread embedded acupuncture
Stimulating acupoints using thread embedded

Locations

Country	Name	City	State
Indonesia	Cipto Mangunkusumo Hospital	Jakarta	DKI Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
Indonesia University

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body weight	Participants' body weight in kilograms	1 month
Primary	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	1 month
Primary	Leptin level	Plasma leptin examination using ELISA method	1 month