Condition category
Nutritional, Metabolic, Endocrine
Date applied
04/11/2020
Date assigned
18/11/2020
Last edited
17/11/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting
Publication status
Results overdue

Plain English Summary

Background and study aims
Polycystic ovary syndrome (PCOS) is a common condition that affects how a woman's ovaries work. It affects 7-10% of women worldwide. It is considered a serious problem as it lasts a lifetime and is not just tied to pregnancy. Electroacupuncture is a form of acupuncture where a small electric current is passed between pairs of acupuncture needles. This study aims to measure the effect of electroacupuncture and drug treatment on insulin resistance in PCOS patients.

Who can participate?
Women aged 18-40 with PCOS and body mass index (BMI) over 23 kg/m²

What does the study involve?
Participants are randomly allocated to be treated with electroacupuncture or sham electroacupuncture three times per week, with intervals of 1-2 days, for 12 times. The drug treatment used is metformin 2 x 500 mg per day. Blood samples are taken to measure insulin and blood glucose at the 1st and 12th session.

What are the possible benefits and risks of participating?
Participants could benefit from an improvement in insulin resistance. The risks include hematoma (collection of blood) at the point the acupuncture needle is inserted.

Where is the study run from?
University of Indonesia – Cipto Mangunkusumo Hospital (Indonesia)

When is the study starting and how long is it expected to run for?
March 2018 to September 2018

Who is funding the study?
investigator initiated and funded

Who is the main contact?
R Muharam
rmuharam@yahoo.com

Trial website

Contact information

Type

Public

Primary contact

Mr R Muharam

ORCID ID

Contact details

Jl. Pangeran Diponegoro No.71
Kenari
Kec. Senen
Kota Jakarta Pusat
Daerah Khusus Ibukota Jakarta
10430
Indonesia
‭+62 (0)812 85143491‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬
rmuharam@yahoo.com

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

0248/UN2.F1/ETIK/2018

Study information

Scientific title

Combination of electroacupuncture and pharmacological treatment in improving insulin resistance (HOMA-IR) in polycystic ovary syndrome patients: a double-blind randomized clinical trial

Acronym

Study hypothesis

The combination of electroacupuncture and pharmacological therapy has better efficacy to improve insulin sensitivity.

Ethics approval

Approved 26/03/2018, Ethics Committee of the Faculty of Medicine, University of Indonesia (Jl. Salemba Raya no.6 Jakarta 10430, PO Box 1358; ‭+62 (0)21 3912477; humas@fk.ui.ac.id, office@fk.ui.ac.id), ref: 18-03-0254

Study design

Double-blind randomized clinical trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a participant information sheet

Condition

Polycystic ovarian syndrome

Intervention

Randomization was done using a computer-based random block table randomizer. The doctors, paramedics, and laboratory personnel do not know whether the subject receives electroacupuncture or sham electroacupuncture. The participants also do not know whether they receive electroacupuncture or sham electroacupuncture.

Participants receive electroacupuncture three times per week, with intervals of 1-2 days, for 12 times. The pharmacological therapy used is metformin 2 x 500 mg per day.

Intervention type

Other

Phase

Drug names

Primary outcome measure

Median HOMA-IR index measured using initial fasting insulin and initial fasting blood glucose at the 1st and 12th session

Secondary outcome measures

1. Mean fasting blood glucose measured using a blood sample before and after intervention at the 1st and 12th session
2. Median fasting insulin measured using a blood sample before and after intervention at the 1st and 12th session

Overall trial start date

26/03/2018

Overall trial end date

20/09/2018

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. 18-40-year-old females
2. BMI >23 kg/m²
3. Volunteer to join and give informed consent

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

44

Total final enrolment

44

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

29/03/2018

Recruitment end date

19/09/2018

Locations

Countries of recruitment

Indonesia

Trial participating centre

University of Indonesia – Cipto Mangunkusumo Hospital
Faculty of Medicine Jl. Pangeran Diponegoro No.71, Kenari, Kec. Senen
Kota Jakarta Pusat, Daerah Khusus Ibukota Jakarta
10430
Indonesia

Sponsor information

Organisation

University of Indonesia

Sponsor details

Division of Reproductive Immunoendocrinology
Department of Obstetrics & Gynecology
Jl. Pangeran Diponegoro No.71
Kenari
Kec. Senen
Kota Jakarta Pusat
Daerah Khusus Ibukota Jakarta
10430
Indonesia
‭+62 (0)812 85143491‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬
rmuharam@yahoo.com

Sponsor type

University/education

Website

http://www.ui.ac.id/

Funders

Funder type

Other

Funder name

investigator initiated and funded

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal.

IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon request from R Muharam (rmuharam@yahoo.com).

Intention to publish date

11/11/2020

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

16/11/2020: Trial's existence confirmed by the Ethics Committee of the Faculty of Medicine, University of Indonesia.