| CTRI Number |
CTRI/2019/03/018306 [Registered on: 28/03/2019] Trial Registered Prospectively |
| Last Modified On: |
16/04/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to compare the efficacy and adverse effects of metformin versus myoinositol plus d-chiroinositol combination therapy in polycystic ovarian syndrome |
|
Scientific Title of Study
|
A prospective randomised comparative study of metformin versus myoinositol plus d-chiroinositol combination therapy in polycystic ovarian syndrome |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sukhmani Jaura |
| Designation |
Junior Resident |
| Affiliation |
Government Medical College, Amritsar, |
| Address |
Department of Pharmacology, Government Medical College,
Circular Road, Amritsar, Punjab-143001
Amritsar
PUNJAB
143001
India |
| Phone |
7696092106 |
| Fax |
|
| Email |
sukhmaniamitoj29@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Jatinder Singh |
| Designation |
Professor |
| Affiliation |
Government Medical College, Amritsar |
| Address |
Department of Pharmacology, Government Medical College,
Circular Road, Amritsar, Punjab-143001
Amritsar
PUNJAB
143001
India |
| Phone |
9876118935 |
| Fax |
|
| Email |
drjatindersingh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sukhmani Jaura |
| Designation |
Junior Resident |
| Affiliation |
Government Medical College, Amritsar |
| Address |
Department of Pharmacology, Government Medical College,
Circular Road, Amritsar, Punjab-143001
Amritsar
PUNJAB
143001
India |
| Phone |
7696092106 |
| Fax |
|
| Email |
sukhmaniamitoj29@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Pharmacology & Department of Obstetrics & Gynaecology, Guru Nanak dev hospital, Government Medical College (GMC), Amritsar, Punjab-143001 |
|
|
Primary Sponsor
|
| Name |
Dr Sukhmani Jaura |
| Address |
Department of Pharmacology, Government Medical College,
Circular Road, Amritsar, Punjab-143001 |
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sukhmani Jaura |
Government Medical College, Amritsar |
Department of Obstetrics & Gynaecology, Guru Nanak dev hospital
Amritsar
PUNJAB |
7696092106
sukhmaniamitoj29@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Government Medical College, Amritsar, Punjab |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E282||Polycystic ovarian syndrome, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Metformin |
Metformin 500 mg BD daily to one group |
| Comparator Agent |
Myoinositol plus d-chiroinositol |
Myoinositol plus d-chiroinositol combination therapy 1000 mg BD daily to other group |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
49.00 Year(s) |
| Gender |
Female |
| Details |
Women fulfilling 2 out of 3 criteria of Rotterdam criteria
Oligo menorrhea and/or Anovulation
Clinical and/or hormonal parameters of hyperandrogenism that may be associated with Hirsutism
Polycystic ovaries in ultrasound findings
|
|
| ExclusionCriteria |
| Details |
Women with pre-existing endocrine disorder
History of Hypertension & Diabetes Mellitus
Women who received previous treatment with other drugs within last 6 months
Pregnancy |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the changes in the hormone levels of LH, FSH, AMH, testosterone, insulin, progesterone, estrogen and regularity of menstrual cycle after giving the interventional treatment. |
3,6,9 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the adverse effects of both treatments |
3,6,9 months |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
29/03/2019 |
| Date of Study Completion (India) |
22/12/2018 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Published in International journal of Basic & Clinical Pharmacology in February 2020 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Polycystic ovarian syndrome is one of the most common endocrine disorders in women of reproductive age. The Rotterdam Criteria is to be fulfilled to diagnose the syndrome which requires the presence of two out of three conditions: Oligomenorrhea and/or anovulation, clinical and/or biochemical signs of hyperandrogenism that may be associated with hirsutism, and ultrasound findings showing polycystic ovaries. Hyperandrogenism is the cornerstone of the syndrome. Insulin resistance and resultant hyperinsulinaemia contribute to hyperandrogenism in these patients. Weight loss or pharmacologic interventions that lower insulin levels have shown to significantly reduce androgen levels and improve menstrual cycle patterns in many of these women. This study is planned specifically to evaluate the efficacy of metformin versus myoinositol plus d-chiroinositol combination therapy in PCOS patients and its subsequent effects on their clinical, hormonal and radiodiagnostic dimensions. The present study will be prospective, randomized parallel design interventional study for the duration of nine months. 50 newly diagnosed PCOS patients from the department of Obstetrics & Gynaecology, Government Medical College, Amritsar will be randomly divided into 2 groups, one group will be given Metformin 500 mg BD & other group Myoinositol plus d-chiroinositol combination therapy 1000 mg BD daily for 9 months. Follow up will be done at 3,6,9 months. At each visit, LH, FSH, AMH, testosterone, insulin, progesterone, estrogen and ultrasonic evidences will be evaluated. |