| CTRI Number |
CTRI/2023/10/058811 [Registered on: 18/10/2023] Trial Registered Prospectively |
| Last Modified On: |
12/10/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
To analyse if T.Metformin along with lifestyle modification is better than only lifestyle modification is treatment of adolescent PCOS. |
|
Scientific Title of Study
|
Comparision of effect of tablet metformin with lifestyle modification and placebo with lifestyle modification on adolescent PCOS - A RANDOMOZED CONTROLLED TRIAL |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jedidiah JF |
| Designation |
Post graduate |
| Affiliation |
Sri manakula vinayagar medical college and hospital |
| Address |
Department of obstetrics and gynaecology, room no.68, sri manakula vinayagar medical college and hospital.
Pondicherry
PONDICHERRY
605107
India |
| Phone |
9080128257 |
| Fax |
|
| Email |
jedidiahfrancis2018@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Nivedita |
| Designation |
Professor |
| Affiliation |
Sri manakula vinayagar medical college and hospital |
| Address |
Department of obstetrics and gynaecology, room no. 68, sri manakula vinayagar medical college and hospital
Pondicherry
PONDICHERRY
605107
India |
| Phone |
9080128257 |
| Fax |
|
| Email |
niveog91@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Jedidiah JF |
| Designation |
Post graduate |
| Affiliation |
Sri manakula vinayagar medical college and hospital |
| Address |
Department of obstetrics and gynaecology, room no 68, sri manakula vinayagar medical college and hospital
Pondicherry
PONDICHERRY
605107
India |
| Phone |
9080128257 |
| Fax |
|
| Email |
jedidiahfrancis2018@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri manakula vinayagar medical college and hospital |
|
|
Primary Sponsor
|
| Name |
Sri Manakula vinayagar medical college and hospital |
| Address |
Smvmch, madagadepet, kalitheerthalkuppam, puducherry 605107 |
| 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 |
| Jedidiah |
Sri manakula vinayagar medical college and hospital |
Department of obstetrics and gynaecology, room no.68.
Pondicherry
PONDICHERRY |
9080128257
jedidiahfrancis2018@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SMVMCH- Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N915||Oligomenorrhea, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Drug tablet Iron suppliments |
Per oral, twice daily, Given for a period of 3 months |
| Intervention |
Drug tablet Metformin |
500mg, per oral, twice daily (BD), for 3months |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
19.00 Year(s) |
| Gender |
Female |
| Details |
Irregular cycle, clinical hyperandrogenism, biochemical hyperandrogenism |
|
| ExclusionCriteria |
| Details |
Primary amenorrhea due to structural deformities, regular cycle, gastritis, gastric ulcer, liver disease, depression or bipolar disorder, contraindication to exercise. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the effect of tablet metformin on biochemical parameters like lutenizing hormone, toral testosterone, lipid profile, HbA1C in adolescent PCOS. |
3months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the effect of tablet metformin and lifestyle modification versus placebo and lifestyle modification for 3months in regularising the menstural cycles, reducing hirsutism, acne and obesity in adolescent PCOS |
3months |
|
|
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 2 |
|
Date of First Enrollment (India)
|
30/10/2023 |
| 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)
|
Closed to Recruitment of Participants |
| 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
|
For treatment of adolescent PCOS generally only lifestyle modification and in severe cases oral contraceptive pills are used currently. In this study if there is a significant improvement in physical and biochemical parameters such as improvement in menstrual cycle regularization, reduction in hyperandrogenism usage of tablet metformin can be considered as an alternate in treating adolescent PCOS since metformin is a relatively safer drug. |