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

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

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.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Procedure: Electroacupuncture; Procedure: Thread embedded acupuncture

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 Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Indonesia
  • DKI Jakarta
    • Jakarta, DKI Jakarta, Indonesia, 10430
      • Cipto Mangunkusumo hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; Stimulating acupoints using electric stimulator
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; Stimulating acupoints using thread embedded

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body weight	Participants' body weight in kilograms	1 month
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
Leptin level	Plasma leptin examination using ELISA method	1 month

Collaborators and Investigators

• Sponsor: Indonesia University
• Investigators: Principal Investigator: Cindy Notonegoro, dr., Faculty of Medicine, University of Indonesia

Study record dates

Study Major Dates

• Study Start (Actual): July 21, 2021
• Primary Completion (Actual): October 26, 2021
• Study Completion (Actual): October 26, 2021

Study Registration Dates

• First Submitted: August 22, 2021
• First Submitted That Met QC Criteria: August 24, 2021
• First Posted (Actual): August 26, 2021

Study Record Updates

• Last Update Posted (Actual): January 27, 2022
• Last Update Submitted That Met QC Criteria: January 12, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: electroacupuncture; obese; dietary intervention; thread embedded acupuncture
• Other Study ID Numbers: 21-05-0530

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No