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

NCT05023148 | Completed

• 1 other identifier: 21-05-0530
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Keywords

electroacupuncture; thread embedded acupuncture; obese; dietary intervention

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Electroacupuncture with dietary intervention

ACTIVE COMPARATOR

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

Thread embedded acupuncture with dietary intervention

ACTIVE COMPARATOR

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

Electroacupuncture PROCEDURE

Stimulating acupoints using electric stimulator

Electroacupuncture with dietary intervention

Thread embedded acupuncture PROCEDURE

Stimulating acupoints using thread embedded

Thread embedded acupuncture with dietary intervention

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

Cipto Mangunkusumo Hospital

Jakarta, DKI Jakarta, 10430, Indonesia

Location

MeSH Terms

Conditions

Obesity

Interventions

Electroacupuncture

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Acupuncture Therapy; Complementary Therapies; Electric Stimulation Therapy; Physical Therapy Modalities; Rehabilitation; Transcutaneous Electric Nerve Stimulation; Analgesia; Anesthesia and Analgesia; Anesthesia

Study Officials

• Cindy Notonegoro, dr.

  Faculty of Medicine, University of Indonesia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors and laboratory analyst do not know which group that participants was assigned in
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: There are two groups of intervention. The first group is getting electroacupuncture treatment and the second group is getting thread embedded acupuncture treatment.

Study Record Dates

• First Submitted: August 22, 2021
• First Posted: August 26, 2021
• Study Start: July 21, 2021
• Primary Completion: October 26, 2021
• Study Completion: October 26, 2021
• Last Updated: January 27, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)