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
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