| CTRI Number |
CTRI/2024/06/068972 [Registered on: 14/06/2024] Trial Registered Prospectively |
| Last Modified On: |
08/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Efficacy of Myo-inositol in PCOS patients |
|
Scientific Title of Study
|
Efficacy of Myo-inositol as an add-on therapy to life style modifications in PCOS patients in Kerala population. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Malini Ajayan |
| Designation |
DM Resident |
| Affiliation |
Amrita Institute Of Medical Science |
| Address |
Dept Of Endocrinology
Amrita Institute Of Medical Science
Kochi Campus
Kochi
Ernakulam
KERALA
682041
India |
| Phone |
9577808108 |
| Fax |
|
| Email |
maliniajayan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Malini Ajayan |
| Designation |
DM Resident |
| Affiliation |
Amrita Institute Of Medical Science |
| Address |
Dept Of Endocrinology
Consultation room -3
G Block
Amrita Institute Of Medical Science
Kochi Campus
Kochi
Ernakulam
KERALA
682041
India |
| Phone |
9577808108 |
| Fax |
|
| Email |
maliniajayan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Malini Ajayan |
| Designation |
DM RESIDENT |
| Affiliation |
Amrita Institute Of Medical Science |
| Address |
Dept Of Endocrinology
Consultation room- 3
G block
Amrita Institute Of Medical Science
Kochi Campus
Kochi
KOCHI
Ernakulam
KERALA
682041
India |
| Phone |
9577808108 |
| Fax |
|
| Email |
maliniajayan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Amrita Institute Of Medical Science
Ponnekkara P.O.
Kochi- 682041
Kerala
India |
|
|
Primary Sponsor
|
| Name |
Amrita Institute Of Medical Science |
| Address |
Amrita Institute Of Medical Science
Ponnekkara P.O.
Kochi- 682041 |
| 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 |
| Dr Malini Ajayan |
Amrita Institute Of Medical Science |
Dept Of Endocrinology
Consultation Room- 3
G block
Amrita Institute Of Medical Science
Ponnekkara P.O.
Kochi - 682041
Kerala
India
Ernakulam
KERALA |
9577808108
maliniajayan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Amritha Institute Of Medical Sciences, Healthcare,Education And Research |
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 |
| Intervention |
Myo Inositol |
Patients will be randomized into two groups based on a computer-generated randomization table. Group I will undergo only lifestyle modifications in terms of Diet control, exercise and behavioural changes , where indi-cated . Group II will receive Tab .Myo-Inositol 1 gm twice a day for a period of 6 months along with follow-ing the proposed lifestyle modifications.
|
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Rotterdam criteria |
|
| ExclusionCriteria |
| Details |
secondary causes of PCOS
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the efficacy of Myo-Inositol as an add on therapy to life style modifications in terms of Hormonal ,Metabolic and Clinical profile in Polycystic ovarian syndrome patients in Kerala population |
Samples will be taken at baseline and end of 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
20/06/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
20/06/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
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
|
Myo-inositol has a beneficial effect on PCOS due to its insulin sensitising activity. However current management guidelines do not use the drug as a first line therapy to combat Insulin resistance. Hence we propose to study the Efficacy of Myo-inositol as an add-on therapy to life style modifications in PCOS patients coming to our Out-patient department in terms of Hormonal ,Metabolic and Clinical profile in South Indian population |