| CTRI Number |
CTRI/2025/02/080001 [Registered on: 06/02/2025] Trial Registered Prospectively |
| Last Modified On: |
21/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
This clinical trial will study how metformin and orlistat influence gut bacteria in women with Polycystic Ovarian Syndrome (PCOS)and track gut bacteria changes and investigate their effects on PCOS symptoms, including weight, insulin resistance, and hormone levels. |
|
Scientific Title of Study
|
Orlistat Versus Metformin induced Gut micro-organisms modification in Polycystic ovarian syndrome patients -A Randomized controlled study |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Divyabharathi |
| Designation |
Postgraduate |
| Affiliation |
SRM university |
| Address |
SRM INSTITUTE OF SCIENCE AND TECHNOLOGY
KATTANKULATHUR CAMPUs
CHENGALPET
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9677364713 |
| Fax |
|
| Email |
divyabharathi1297@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Saswati Tripathy |
| Designation |
Proffesor |
| Affiliation |
SRM INSTITUTE OF SCIENCE AND TECHNOLOGY |
| Address |
SRM INSTITUTE OF SCIENCE AND TECHNOLOGY
KATTANKULATHUR CAMPUs
CHENGALPET
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9677364713 |
| Fax |
|
| Email |
saswatit@srmist.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Divyabharathi |
| Designation |
Postgraduate |
| Affiliation |
SRM university |
| Address |
No.12
Department of OBG
SRM Medical College hospital and research centre
SRM Institute of science and technology
Katankulathur campus
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9677364713 |
| Fax |
|
| Email |
divyabharathi1297@gmail.com |
|
|
Source of Monetary or Material Support
|
| No.12, Department of OBG
SRM medical college hospital and research centre.
SRM Institute of medical science and Technology
Kattankulathur campus
Chengalpattu district ,Tamil nadu. India
603203 |
|
|
Primary Sponsor
|
| Name |
Dr Saswati tripathy |
| Address |
No.12, Department of OBG
SRM medical college hospital and research centre.
SRM Institute of medical science and Technology
Kattankulathur campus
Chengalpattu district ,Tamil nadu. India
603203 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| DrDivyabharathi |
SRM Medical college Hospital and Research centre |
No.12, Department of OBG
SRM medical college hospital and research centre.
SRM Institute of medical science and Technology
Kattankulathur campus
Chengalpattu district ,Tamil nadu. India
603203
Kancheepuram
TAMIL NADU |
9677364713
divyabharathi1297@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRM Medical college hospital and reserch centre |
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 |
METFORMIN |
500 MG ONCE DAILY FOR 3 MONTHS |
| Intervention |
ORLISTAT |
60 MG TWICE DAILY FOR 3 MONTHS |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Patients diagnosed as PCOS according to ROTTERDAM CRITERIA
With at least two of the following features :
Oligo-amenorrhea or chronic anovulation
Clinical and/or biochemical hyperandrogenism
Ultrasound appearance of polycystic ovaries
Able and willing to comply with the interventions and follow-up evaluations |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Gut bacterial diversity before and after the treatment with metformin and orlistat in PCOS
|
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Effects of Orlistat and Metformin in improvement of clinical and metabolic profile in PCOS patients
|
6 moths |
|
|
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
07/02/2025 |
| 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="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
PCOS being a heterogenous
disorder with diverse features, obesity influences the phenotypic expression of
PCOS, exacerbating metabolic, reproductive, and psychological features.
Weight loss reduces abdominal fat
and insulin resistance and improves clinical features of PCOS.
Endotoxemia, a persistent
inflammatory response, short-chain fatty acids and bile acid metabolism are all
linked to the development of insulin resistance.
Moreover, people with PCOS have
been found to have a major imbalance in their gut flora.
Reducing the insulin resistance
and improving the gut flora, improves the various clinical features in PCOS
Orlistat helps to improve this heterogeneous symptoms of PCOS
by altering abnormal gut microbiota to normal gut microbiota
|