| CTRI Number |
CTRI/2025/04/085516 [Registered on: 24/04/2025] Trial Registered Prospectively |
| Last Modified On: |
23/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of soyabeans on reduction of menopausal symptoms among peri menopausal women |
|
Scientific Title of Study
|
Effect of soyabeans on reduction of menopausal symptoms among perimenopausal women |
| Trial Acronym |
to reduce menopausal symptoms |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Chandarlekha K |
| Designation |
M.Sc Nursing student |
| Affiliation |
Pondicherry Institute of Medical Sciences |
| Address |
No.212 Vannas Kuttai Street Edayanchavadi Vanur Taluka Auroville S.O Villupuram Tamil Nadu 605101 Mobile No-7708277426
Email Id-chandralekachandu095@gmail.com
Viluppuram
TAMIL NADU
605101
India |
| Phone |
7708277426 |
| Fax |
|
| Email |
chandralekachandu095@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mrs Pon Princess Mano |
| Designation |
Assistant professor Dept.of OBG Nursing Pondicherry Institute of Medical Sciences |
| Affiliation |
Pondicherry Institute of Medical Sciences |
| Address |
Ganapathichettikulam village No.20,Kalapet,Pondicherry 605014 Pondicherry Institute of Medical Sciences.Room no.10
Pondicherry
PONDICHERRY
605014
India |
| Phone |
9952491866 |
| Fax |
|
| Email |
p.princeprincess@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
Mrs Pon Princess Mano |
| Designation |
Assistant professor Dept.of OBG Nursing Pondicherry Institute of Medical Sciences |
| Affiliation |
Pondicherry Institute of Medical Sciences |
| Address |
Ganapathichettikulam village No.20,Kalapet,Pondicherry 605014 Pondicherry Institute of Medical Sciences.Room no.10
Pondicherry
PONDICHERRY
605014
India |
| Phone |
9952491866 |
| Fax |
|
| Email |
p.princeprincess@yahoo.in |
|
|
Source of Monetary or Material Support
|
| parents of the researcher |
|
|
Primary Sponsor
|
| Name |
Kalvi |
| Address |
No.212 Vannas Kuttai Street Edayanchavadi Vanur Taluka Auroville S.O Villupuram Tamil Nadu 605101 Mobile No-9843188475
Email Id-chandralekachandu095@gmail.co |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 |
| chandarlekha |
Irumbai |
Edayanchavadi village
Viluppuram
TAMIL NADU |
7708277426
chandralekachandu095@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PIMS INSTITUTE ETHICS COMMITTEE(IEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Perimenopausal women |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not applicable |
Not applicable |
| Intervention |
soyabeans |
Informed consent will be taken from the participants after explaining the purpose of the study.
Researcher will conduct pre-test using standardized scale on “0”day.
The researcher will soak the soyabeans the previous night 8-12 hours and then cook it in a pressure cooker or vessel with pinch of salt.
Next day (Day 1) morning 50 grams of cooked soyabeans will be distributed to each participant at their doorstep and instructed to consume along with breakfast.This will continued for 21 days.
On day 22 the researcher conduct post -test to assess the perimenopausal symptoms.
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
Peri menopausal women who, are living in Irumbai panchayat in the age group of 40-50 years.
Those who are having variability and fluctuation of menstrual cycle.
|
|
| ExclusionCriteria |
| Details |
Peri menopausal women who, are under hormone replacement therapy.
Those who have history of allergy to soyabeans.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction of menopausal symptoms among perimenopausal women after intervention. |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assess the level of menopausal symptoms |
6 months |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
05/05/2025 |
| 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="6"
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
|
This study is a pre experimental one group pre test post test design, trail for evaluating the effect of soyabeans 50 gram of soyabeans on reducing menopausal symptoms among perimenopausal women for 21 days in 60 women that will be conducted in Edayanchavadi village in India. |