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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  PCOD,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
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.

 
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