| CTRI Number |
CTRI/2025/07/089948 [Registered on: 01/07/2025] Trial Registered Prospectively |
| Last Modified On: |
07/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effect of add on therapy alpha-lipoic acid on metabolic markers in overweight PCOS patients in a tertiary care hospital: A double blind, randomized, Placebo controlled trial |
|
Scientific Title of Study
|
Effect of add-on therapy alpha lipoic acid on insulin resistance in high body mass index polycystic ovary syndrome patients -A randomized , double -blinded , placebo-controlled trial |
| Trial Acronym |
yes |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
vijayalakshmi |
| Designation |
MD Pharmacology |
| Affiliation |
SRM medical college hospital research instiute |
| Address |
SRM mrdical college research instiute ,potheri , katankullathur
Chennai
TAMIL NADU
603203
India |
| Phone |
8667267707 |
| Fax |
|
| Email |
kavihan20@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sangeetha Raja |
| Designation |
Proffessor |
| Affiliation |
SRM medical college hospital research instiute |
| Address |
Department of pharmacology
SRM Medical college Hospital research instiute
Potheri Katankullathur, Chennai,Tamil Nadu
Department of pharmacology
SRM medical college Hospital and research centre
Kattankulathur
Chennai , Tamilnadu
Chennai
TAMIL NADU
603203
India |
| Phone |
9176630021 |
| Fax |
|
| Email |
sangeeta1@srmist.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sangeetha Raja |
| Designation |
PROFESSOR |
| Affiliation |
SRM medical college hospital research |
| Address |
SRM Medical college Hospital research instiute
Potheri Katankullathur
Chennai
TAMIL NADU
603203
India |
| Phone |
9176630021 |
| Fax |
|
| Email |
sangeeta1@srmist.edu.in |
|
|
Source of Monetary or Material Support
|
| SRM medical college hospital Research centre, potheri , SRM Nagar ,Katankullathur,Tamilnadu - 603203 |
|
|
Primary Sponsor
|
| Name |
Vijayalakshmi M |
| Address |
Department of pharmacology ,SRM medical college hospital research centre,SRM nagar, Katankulathur
Potheri Katankullathur, Tamilnadu -603 203 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR M vijayalakshmi |
Srm medical college hospital research instiute |
Room 11 , ground floor , department of obstertic and gynecology
Chennai
TAMIL NADU |
8667267707
kavihan20@gmail.com |
| Dr Sangeetha Raja |
Srm medical college hospital research instiute |
Room no.4 ,1st floor , department of pharmacology
Chennai
TAMIL NADU |
9176630021
sangeeta1@srmist.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instiutional Ethic committe-students, SRM medical college hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E889||Metabolic disorder, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Alpha lipoic acid |
Alpha lipoic acid is a caprylic acid derived antioxidant for 12 weeks |
| Comparator Agent |
Placebo |
Placebo is a starch compound will be looks similar like alpha lipoic acid , will be given for 12 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Female patients whose bmi is above 23kg/m2 who is diagnosed with PCOS 7 taking metformin for a period 3 months |
|
| ExclusionCriteria |
| Details |
Breastfeeding, Lactation mothers
Females affected by renal disease, liver disease, cardiac disease
H/o pt taking alcohol
Pcos pts who is on hormonal treatment |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in Insulin sensitivity by estimating HOMA-IR from baseline to 12 weeks in overweight &obese PCOS patients |
Improvement in Insulin sensitivity by estimating HOMA-IR from baseline to 12 weeks in overweight &obese PCOS patients |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in liver index scores by measuring lipid accumulation product hepatic steatosis index from baseline to 12 weeks |
12 weeks |
|
|
Target Sample Size
|
Total Sample Size="84"
Sample Size from India="84"
Final Enrollment numbers achieved (Total)= "84"
Final Enrollment numbers achieved (India)="84" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/07/2025 |
| Date of Study Completion (India) |
01/12/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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 MD thesis proposal aims to assess the impact of alpha lipoic acid supplementation on insulin resistance in Overweight and obese PCOS patients. The study, with a sample size of 84, will evaluate insulin resistance markers, NAFLD indexes. Participants will be randomized into probiotic and placebo groups, receiving treatment for 12 weeks, with regular follow-ups to monitor compliance and adverse effects. The study outcomes may contribute valuable insights to the limited body of randomized controlled trials on the alpha lipoic acid in PCOS patients |