| CTRI Number |
CTRI/2020/01/022952 [Registered on: 27/01/2020] Trial Registered Prospectively |
| Last Modified On: |
14/09/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
PHYTOESTROGEN RICH SUPPLEMENTATION ON MENSTRUAL IRREGULARITIES, PSYCHOLOGICAL STRESS AND PHYSICAL ACTIVITY LEVELS IN WOMEN WITH PCOS |
|
Scientific Title of Study
|
PHYTOESTROGEN RICH SUPPLEMENTATION ON MENSTRUAL IRREGULARITIES, PSYCHOLOGICAL STRESS AND PHYSICAL ACTIVITY LEVELS IN WOMEN WITH PCOS |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
K GAYATHRI |
| Designation |
Ph.D Research scholar |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research(DU) |
| Address |
Room no-20, Sathyalok Charitable trust, chettiyar agaram street, porur, chennai116
Department of Clinical Nutrition,
Sri Ramachandra Institute of Institute of Higher Education and Research(DU),
Porur, Chennai-116
Chennai
TAMIL NADU
600116
India |
| Phone |
9123567913 |
| Fax |
|
| Email |
gayathrikalidoss7@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr V SUPRIYA |
| Designation |
Assistant professor |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research(DU) |
| Address |
Department of Clinical Nutrition,
Sri Ramachandra Institute of Institute of Higher Education and Research(DU),
Porur, Chennai-116
Chennai
TAMIL NADU
600116
India |
| Phone |
9841273715 |
| Fax |
|
| Email |
priiyas@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr V SUPRIYA |
| Designation |
Assistant professor |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research(DU) |
| Address |
Department of Clinical Nutrition,
Sri Ramachandra Institute of Institute of Higher Education and Research(DU),
Porur, Chennai-116
Chennai
TAMIL NADU
600116
India |
| Phone |
9841273715 |
| Fax |
|
| Email |
priiyas@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Founder Chancellor shri NPV Ramasamy udayar research fellowship |
| Address |
Sri Ramachandra Institution of Higher education and Research (Deemed to be university), chennai-116 |
| 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 |
| K GAYATHRI |
Obstetrics and Gynecology out patient unit(OP) |
G-block
Sri Ramachandra Medical Centre and Hospital,
Department of Clinical Nutrition
SRIHER(DU)
Chennai
TAMIL NADU |
9123567913
gayathrikalidoss7@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
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 |
Dal mix powder |
it gives for the treatment for PCOS. 30g of supplement (Dal mix powder) will be providedto interventional group for 60 days. |
| Comparator Agent |
Plain dal powder |
it will be provided to the control group. Its not contain the phytoestrogen rich ingredients in it. Plain dal powder 30g/day will be provided to the control group for 60 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
pre menopausal and reproductive aged women 18-45 years, patients willing to give inform consent |
|
| ExclusionCriteria |
| Details |
women with hysterectomy, cushing syndrome, hypo gonadisam and thyroid dysfunction |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| improvement in ovulation, decrease in blood glucose level and weight, reduced stress level |
The Primary outcome will be measured after two months of supplementation period. The expected outcomes are improvement in ovulation, decrease in blood glucose level and weight, reduced stress level |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduced oxidative stress and reduced facial hair growth |
reduction in oxidative stress |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
27/01/2020 |
| Date of Study Completion (India) |
16/06/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Published two original research articles |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
The present study employed
a unique approach by combining the phytoestrogen-rich ingredients and developed
the phytoestrogen-rich supplement. Its potential impact among women with PCOS
was analyzed. Results showed a
potential decrease in depression, anxiety, and stress levels among the PCOS
subjects. It accentuates that providing appropriate dietary counseling could have
a potential impact in reducing LDL, free cholesterol, depression, anxiety, and
stress levels in individuals with PCOS. It also reported an increase in HDL, FSH levels and improved the regulation of menstrual
cycles among the subjects in the intervention group. Overall the study
emphasized the statement that omega-3-fatty acid, polyphenols and flavonoids
content in the phytoestrogen rich supplement had a positive impact in the
management of PCOS. This highlights the need for longer-term studies to explore
the extended benefits of the interventions and lifestyle changes proposed in
the study |