Clinical trial NCT05023148: Comparison of Electroacupuncture and Thread Embedded Acupuncture With Dietary Intervention in Obese Patients
Official title: Comparison Therapeutic Effects Between Electroacupuncture and Thread Embedded Acupuncture in Obese Patients With Dietary Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: electroacupuncture
thread embedded acupuncture
obese
dietary intervention
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2021-08-26
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: There are two groups of intervention. The first group is getting electroacupuncture treatment and the second group is getting thread embedded acupuncture treatment.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Body weight
timeFrame: 1 month
measure: Waist circumference
timeFrame: 1 month
measure: Leptin level
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: Cipto Mangunkusumo Hospital
state: DKI Jakarta
Study officials:
affiliation: Faculty of Medicine, University of Indonesia
name: Cindy Notonegoro, dr.
role: PRINCIPAL_INVESTIGATOR
References: