| CTRI Number |
CTRI/2025/04/085859 [Registered on: 28/04/2025] Trial Registered Prospectively |
| Last Modified On: |
28/04/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of Metformin and Berberine in PCOD patients |
|
Scientific Title of Study
|
Effects of Lifestyle Modification with Myoinositol and Berberine versus Myoinositol and Metformin in Women with Polycystic Ovary Syndrome: A Prospective Randomized Study: A case report |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sathyapriya Balasubramaniyan |
| Designation |
Fertility consultant |
| Affiliation |
A4 Hospital and Fertility centre Pvt Ltd |
| Address |
Room no 1,
Department of Reproductive medicine,
A4 Fertility Centre
87, Arcot Rd, AVM Avenue, Virugambakkam
Chennai
TAMIL NADU
600092
India |
| Phone |
9884339538 |
| Fax |
|
| Email |
dr_sathyapriya@a4hospital.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sathyapriya Balasubramaniyan |
| Designation |
Fertility consultant |
| Affiliation |
A4 Hospital and Fertility centre Pvt Ltd |
| Address |
Room no 1,
Department of reproductive medicine
A4 Fertility Centre
87, Arcot Rd, AVM Avenue, Virugambakkam, Chennai, Tamil Nadu 600092
Chennai
TAMIL NADU
600092
India |
| Phone |
9884339538 |
| Fax |
|
| Email |
dr_sathyapriya@a4hospital.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sathyapriya Balasubramaniyan |
| Designation |
Fertility consultant |
| Affiliation |
A4 Hospital and Fertility centre Pvt Ltd |
| Address |
room no 1, Department of Reproductive medicine
A4 Fertility Centre
87, Arcot Rd, AVM Avenue, Virugambakkam, Chennai
Chennai
TAMIL NADU
600092
India |
| Phone |
9884339538 |
| Fax |
|
| Email |
dr_sathyapriya@a4hospital.com |
|
|
Source of Monetary or Material Support
|
| Room no 1
A4 hospitals and fertility centre, No 87 Arcot road Virugambakkam, Chennai Tamilnadu |
|
|
Primary Sponsor
|
| Name |
Dr Sathyapriya Balasubramaniyan |
| Address |
Department of Reproductive medicine
Room no 1
87, Arcot Rd, AVM Avenue, Virugambakkam, Chennai, Tamil Nadu 600092 |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 |
| DrSathya priya |
A4 Hospitals and Fertility centre Pvt Ltd |
No 87 Arcot road, AVM Avenue near vembuliamman kovil, virugambakkam
Chennai
TAMIL NADU |
9884339538
dr_sathyapriya@a4hospital.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| A4 Hospital - instituitional ethics commitee |
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 |
| Comparator Agent |
Myoinositol and Berberine |
Medication has been prescribed for 3 months with diet and lifestyle modificationand Improvement is noted in PCOS parameters at the end of 3 months |
| Comparator Agent |
Myoinositol and metformin |
Medication has been prescribed for 3 months with diet and lifestyle modificationand Improvement is noted in PCOS parameters at the end of 3 months |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
BMI 18 to 35
PCOS as defined by Rotterdams criteria and all 4 phenotypes
Mild to moderate male factor TMSC more 3 million |
|
| ExclusionCriteria |
| Details |
Endometriosis
More than 10 years of infertility
Low ovarian reserve
Severe male factor infertility
Bilateral tubal block
DM
Patients already on the same medications prior to consultation |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Clinical, Metabolic, hormonal parameters |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess improvement in cycle regularity and rate of spontaneous conception |
at start of study and at the end of three months |
|
|
Target Sample Size
|
Total Sample Size="240"
Sample Size from India="240"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
15/05/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
15/05/2025 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study aimed to evaluate the impact of Lifestyle Modification with Myoinositol and Berberine versus Myoinositol and Metformin on Clinical, hormonal, carbohydrate and lipid parameters in women with PCOS at the end of three months. this is proposed to be a multi centre, prospective randomized study. |