| CTRI Number |
CTRI/2017/09/009807 [Registered on: 18/09/2017] Trial Registered Retrospectively |
| Last Modified On: |
14/09/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study of the effect of Metformin,OC pills versus their combination on thyroid and lipid profile in patients with Polycystic ovary syndrome |
|
Scientific Title of Study
|
Study of the effect of Metformin,Estrogen-progesterone pills versus their combination on thyroid profile and lipid profile in patients with Polycystic ovary syndrome attending a Tertiary Care Hospital |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
E Sudha Rani |
| Designation |
Dm resident |
| Affiliation |
NIMS |
| Address |
Nizams Institute Of Medical Sciences,
Punjagutta,
Hyderabad.
Hyderabad ANDHRA PRADESH 500082 India |
| Phone |
|
| Fax |
|
| Email |
sudharanierra@yahoo.com |
|
Details of Contact Person Scientific Query
|
| Name |
P Usha Rani |
| Designation |
Prof and Head |
| Affiliation |
NIMS |
| Address |
Nizams Institute Of Medical Sciences,
Punjagutta,
Hyderabad.
Hyderabad ANDHRA PRADESH 500082 India |
| Phone |
|
| Fax |
|
| Email |
ushapingali@yahoo.com |
|
Details of Contact Person Public Query
|
| Name |
P Usha Rani |
| Designation |
Prof & Head |
| Affiliation |
NIMS |
| Address |
Nizams Institute Of Medical Sciences,
Punjagutta,
Hyderabad.
Hyderabad ANDHRA PRADESH 500082 India |
| Phone |
|
| Fax |
|
| Email |
sudharanierra@yahoo.com |
|
|
Source of Monetary or Material Support
|
| DR.E.SudhaRani
Dmresident
Nizams Institute Of Medical Sciences,
Punjagutta,
Hyderabad. |
|
|
Primary Sponsor
|
| Name |
self |
| Address |
academic trial for thesis |
| 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 |
| E Sudha Rani |
CP &T DEPT |
Nizams Institute Of Medical Sciences,
Punjagutta,
Hyderabad.
HYDERABAD Hyderabad ANDHRA PRADESH |
9949506025
SUDHARANIERRA@YAHOO.COM |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NIMS INSTITUTIONAL ETHICS COMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
PCOD, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1. All adult patients (18 to 40 years old) who are newly diagnosed with PCOS and have shown no symptomatic benefit after being prescribed lifestyle modification for 3 months.
2. Patients who are willing to give written informed consent.
3. Patients who have not previously diagnosed with a thyroid disorder.
|
|
| ExclusionCriteria |
| Details |
1. Pregnant and lactating women.
2. Patients with other comorbid conditions
3. Patients who are taking other medications which could interfere with planned biochemical measurements.
4. Patients who have a history of treatment with study medications or any other androgen progestin or estrogen consumption, for any other indications in the past 6 months.
5. Patients who have known hypersensitivity to the study medications
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Effect of Metformin, Estrogen-progesterone pills versus their combination on thyroid and lipid profile in PCOS patients. |
1,3MONTHS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
(1) Correlation between thyroid profile, lipid profile with age and BMI.
(2) Comparison of the effect of Metformin, Estrogen-progesterone pills versus their combination on thyroid profile, lipid profile in PCOS patients.
|
1,3 MONTHS |
|
|
Target Sample Size
|
Total Sample Size="90" Sample Size from India="90"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
09/01/2017 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
not published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The present study will be a prospective observational study designed to be conducted in patients diagnosed with PCOS who are attending the outpatient department of Gynecology, NIMS. All adult patients (18 to 40 years old) who are newly diagnosed with PCOS and have shown no symptomatic benefit after being prescribed lifestyle modification for 3 months will be included in the study. The study will be conducted after obtaining the approval of the institutional ethics committee and will be conducted over a period of six months. The patients will be selected to participate in the study based on the eligibility criteria. Study objectives and procedure will be explained to the patient. Written informed consent will be taken before the patients are recruited into the study after confirmation of diagnosis by a specialist physician. A structured case detail form will be used to record the patient-specific information, including personal data, demographic characteristics, past and current medical conditions and drug history. Weight in (kg), height in (cm), and vital parameters will be measured for each patient. Body mass index (BMI) will be calculated as weight (kg)/height (m)2. Five milliliters of venous blood will be collected from each participant for the biochemical tests. The blood samples will be drawn after overnight fasting in the morning (between 8 a.m. and 10 a.m. ).Standard laboratory procedures [Enzymatic colorimetric methods were used to determine total cholesterol (CHOD-PAP method), TGs (GPO-PAP method), HDL-C (Direct -PEG), and LDL-C levels using the cobas® 6000 analyzer Roche Diagnostics USA . Electrochemiluminescent immunoassays (ECLIA) for TSH, T4, and T3. FBS (GOD-POD) and HbA1c using HPLC method]. Fasting blood sugar, glycosylated hemoglobin (HbA1c) will be assessed immediately using whole blood. After taking the baseline readings as above ,the patients will randomized through the block randomisation and divided into three equal groups (n=30, each group). One group was prescribed with 1000 mg Metformin daily( Glyciphage SR 1gm), 2nd group will be with combination of 1000 mg Metformin and Cyproterone acetate 2mg/ethinyl estradiol 0.035mg (Diane-35; 21 days per month followed by a 7-day pill-free period ) and 3rd group will be suggested Cyproterone acetate 2mg/ethinyl estradiol 0.035mg (Diane-35; 21 days per month followed by a 7-day pill-free period). The patients will be followed up for a period of 3 months and the tests will be repeated at the end of 1 month and 3 months of the followup period. The medication of the patient will be either continued or terminated after the study based on the physician discretion and improvement of condition. |