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CTRI Number  CTRI/2025/04/084887 [Registered on: 16/04/2025] Trial Registered Prospectively
Last Modified On: 06/03/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A clinical study on Perimenopause symptoms.  
Scientific Title of Study   A randomized, placebo-controlled, parallel arm clinical study to evaluate the efficacy and safety of Female Health Support (GP/PROD/2025/005) in perimenopause symptoms in women. 
Trial Acronym  NA 
Secondary IDs if Any  
Secondary ID  Identifier 
MHC/CT/24-25/058 [Version 1.00 dated : 11-February-2025]  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shilpa P Kshirsagar  
Designation  Gynecologist  
Affiliation  Lokmanya Medical Research Centre and Hospital  
Address  Fourth floor OPD 401,314 B Telco Road, Chinchwad

Pune
MAHARASHTRA
411033
India 
Phone  9689904101  
Fax  -  
Email  shilpakshirsagar.g@gmail.com   
 
Details of Contact Person
Scientific Query  
Name  Dr Shridhar J Pandya  
Designation  Director  
Affiliation  Gplife Healthcare Pvt. Ltd.  
Address  705-706, Orbit-1 Building, Punagum-Saroli Road, Near RRTM Market

Surat
GUJARAT
395010
India 
Phone  9824917109  
Fax  -  
Email  gplifehealthcare@gmail.com   
 
Details of Contact Person
Public Query  
Name  Dr Dheeraj H Nagore  
Designation  Director  
Affiliation  Mprex Healthcare Pvt. Ltd  
Address  Office Number 813-816 Sai Millenium, Mumbai Pune Bypass Road Flyover, Punawale

Pune
MAHARASHTRA
411033
India 
Phone  9158791967  
Fax  -  
Email  dheeraj@mprex.in   
 
Source of Monetary or Material Support  
Gplife Healthcare Pvt. Ltd. 705-706, Orbit-1 Building, Punagum-Saroli Road, Near RRTM Market, Surat, 395010, Gujarat, India.  
 
Primary Sponsor  
Name  Gplife Healthcare Pvt Ltd  
Address  705-706, Orbit-1 Building, Punagum-Saroli Road, Near RRTM Market, Surat, 395010, Gujarat, India.  
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Shilpa P Kshirsagar   Lokmanya Medical Research Centre and Hospital   Fourth Floor OPD, 401, 314 B Telco Road, Chinchwad Pune MAHARASHTRA
Pune
MAHARASHTRA 		 9689904101
-
shilpakshirsagar.g@gmail.com  
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics of CommitteeLokmanya Medical Research Centre, Pune  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Perimenopause Symptoms 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Female Health Support (GP/PROD/2025/005)   1 Tablet twice a day, 30 minutes before meal.  
Comparator Agent  Placebo  1 Tablet twice a day, 30 minutes before meal. 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  55.00 Year(s)
Gender  Female 
Details  Participants meeting all the following criteria will be eligible for the study:
1. Female participants of age between 40-55 years (both inclusive);
2. Must be experiencing at least two symptoms of menopause, such as sleep disturbances, mood changes, fatigue, lack of energy, hot flashes, night sweats, irritability, anxiety.
3. Beck Depression Inventory 2nd Edition score not more than 19 (minimal-mild depression) at screening;
4. Participants in good general health, in the opinion of the investigator, based on medical history, physical examination and clinical examination at screening.
5. Female participants willing to provide informed consent.
 
 
ExclusionCriteria 
Details  Participants meeting any of the following criteria will not be eligible for the study:
1.Current or previous history of any malignancy;
2.Women undergoing hormone replacement therapy;
3.Any clinically significant prior or ongoing history of gynecological disorders, kidney/liver disease, thyroid disorder;
4.Any other history, condition, therapy, or uncontrolled intercurrent illness which could, in the opinion of the investigator, affect compliance with study requirements;
5.History of food or pollen allergy;
6.Clinically relevant drug or alcohol abuse or smoking;
7.Pregnant or nursing;
8.Participant using or had used any herbs, dietary supplements, medicines or hormonal therapy that contained estrogenic compounds;
9.Participation in any other clinical study within the past 3 months or ongoing;
10.Significant mental health issues that could affect study findings, such as anxiety, depression, or other mental health disorders;
11.Any other reason that, in the opinion of the investigator, excludes the subject from eligibility for study participation;
12.Inability to provide reliable data due to Cognitive impairment or language barriers that may prevent accurate reporting of symptoms
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Assessment of-
1.Change in Menopausal Index of Blatt and Kupperman.
2.Change in sleep quality using PROMIS Sleep Disturbance or Sleep-Related Impairment questionnaire.
3.Change in estradiol level, follicle stimulating hormone (FSH), dehydroepiandrosterone sulfate (DHEAS) level.
4.Change in depression using Beck Depression Inventory 2nd Edition score. 		 Screening, Visit 1, Visit 2, Visit 3 and Visit 4  
 
Secondary Outcome  
Outcome  TimePoints 
Assessment of-
1.Change in fatigue using Fatigue severity scale score.
2.Change in mood using Profile of Mood Status- 2 questionnaire score screening
3.Change in Quality of life using World Health Organization Quality of Life (WHOQOL-BREF) questionnaire score.
4.Safety parameters (CBC, LFT, RFT, and Lipid profile).
5.Changes in vital signs throughout the study.
6.Adverse events profile
7.Compliance and tolerability of the investigational product throughout the study.
 		 Screening, Visit 1, Visit 2, Visit 3 and Visit 4  
 
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 2 
Date of First Enrollment (India)   01/05/2025 
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 randomized, placebo-controlled clinical study aims to evaluate the efficacy and safety of Female Care supplementation (GP/PROD/2025/005) in managing perimenopause symptoms. The study will enroll 60 women, equally divided between test and placebo groups, over three menstrual cycles. Participants will undergo four scheduled visits, from screening through three menstrual cycles. The study will assess multiple endpoints including changes in menopausal symptoms using the Blatt and Kupperman Index, sleep quality, hormone levels (estradiol, FSH, DHEAS), depression scores, fatigue severity, mood status, and quality of life. Safety monitoring includes blood parameters, vital signs, and adverse events tracking. The comprehensive evaluation will measure both physiological and psychological aspects of perimenopause, along with product compliance and tolerability.
 
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