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CTRI Number  CTRI/2025/02/080850 [Registered on: 18/02/2025] Trial Registered Prospectively
Last Modified On: 12/09/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   To assess the effect of Libifem® (VL-GF-01) on Fertility in Women with Diminished Ovarian Reserve.  
Scientific Title of Study   A Randomized, Double-Blind, Placebo-Controlled Clinical Study to assess the effect of Libifema (VL-GF-01) on Fertility in Women with Diminished Ovarian Reserve 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
GR/240801/IP/FF Version No: 1.0 Date: 26th November, 2024  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sanjay Vaze 
Designation  Sr.Manager-Clinical Development 
Affiliation  Vedic Lifesciences Pvt Ltd 
Address  Vedic Lifesciences Pvt Ltd 118 B Morya House off New Link Road Andheri West Mumbai Mumbai (Suburban) Mumbai (Suburban) MAHARASHTRA

Mumbai
MAHARASHTRA
400053
India 
Phone  8655670964  
Fax    
Email  sanjay.v@vediclifesciences.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sanjay Vaze 
Designation  Sr.Manager-Clinical Development 
Affiliation  Vedic Lifesciences Pvt Ltd 
Address  Vedic Lifesciences Pvt Ltd 118 B Morya House off New Link Road Andheri West Mumbai Mumbai (Suburban) Mumbai (Suburban) MAHARASHTRA


MAHARASHTRA
400053
India 
Phone  8655670964  
Fax    
Email  sanjay.v@vediclifesciences.com  
 
Details of Contact Person
Public Query  
Name  Dr Shubhangi Mote 
Designation  Project Lead. 
Affiliation  Vedic Lifesciences Pvt Ltd 
Address  Vedic Lifesciences Pvt Ltd 118 B Morya House off New Link Road Andheri West Mumbai Mumbai (Suburban) Mumbai (Suburban) MAHARASHTRA

Mumbai
MAHARASHTRA
400053
India 
Phone  8655448527  
Fax    
Email  shubhangi.m@vediclifesciences.com  
 
Source of Monetary or Material Support  
Vedic Lifesciences Pvt. Ltd. 118-B, Morya House, off New Link Road, Andheri West Mumbai –400053, Maharashtra, India 
 
Primary Sponsor  
Name  Vedic Lifesciences Pvt. Ltd 
Address  Vedic Lifesciences Pvt Ltd 118 B Morya House off New Link Road Andheri West Mumbai Mumbai (Suburban) MAHARASHTRA 400053 India 
Type of Sponsor  Contract research organization 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 12  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr T Sasikala  Govt. Medical College & Govt. General Hospita  Govt. Medical College & Govt. General Hospital, Research Wing, 2nd floor, Beside FM Ward, GGH, Srikakulam - 532001, A.P., India.
Srikakulam
ANDHRA PRADESH 		 9573405562

drtsasikala@gmail.com 
Dr Nutan Prabhakar Wanjare  Imperial Multispeciality Hospital,  Gate No. 1193, Pingle Pride, Near Radha Swami Ashram, Chikhali, Pune - 411062.
Pune
MAHARASHTRA 		 9028154345

dr.nutanwanjare@gmail.com  
Dr Neha Vasishth  Jaipur National University Institute for Medical Sciences and Research  Agra - Jaipur Rd, near New RTO Office, Jagatpura, Jaipur, Rajasthan 302017.
Jaipur
RAJASTHAN 		 7597060296

vashisthdrneha@gmail.com 
Dr Shiksha Gupta  Nand Hospital  Hanuman Temple, Vasna - Bhayli Main Road Next to Shantidham Society, Vadodara, India.
Vadodara
GUJARAT 		 9898531389

drshikshaicr@gmail.com 
Dr Meena Vaswani  Padmashree Dr. D.Y. Patil Hospital  sector - 5, Ayyappa Mandir Road, Nerul - Navi - Mumbai - 400706
Mumbai
MAHARASHTRA 		 9869084018

meena.satia@dypatil.edu 
Dr Poonam Goyal  Panchsheel Hospital Pvt. Ltd  C-3/62-A,63-A Yamuna Vihar Delhi - 110053
North East
DELHI 		 9811081811

goyalpoonam29@gmail.com 
Dr Vidhi Parikh  Parikh Hospital  Police station, Sardar patel ring road, opposite Nikol, Nikol, Ahmedabad, Gujarat 382350
Ahmadabad
GUJARAT 		 9714928299

drvidhiparikh@gmail.com 
Dr Pragya Pandey   Pragya Mother & Child care Hospital  Plot No - 9, Rashmi Nagar Colony, Lanka, Varanasi - 221005.
Varanasi
UTTAR PRADESH 		 9696519115

pragyamadhukar@gmail.com 
Dr Ruchika Garg  S.N. Medical College Agra  Near Central Library Moti Katra Mantola, Agra, U.P. - 282003
Agra
UTTAR PRADESH 		 9720004485

ruchikagargagra@gmail.com 
Dr Kinjal Thakkar  Sachi Hospital  B-28,Jay Garvi Gujarat Society, Jashoda Nagar Rd,Near Gour Na kuvo, Maninagar, East,Gujarat-380008.
Ahmadabad
GUJARAT 		 7285824742

kinjalthacker44@gmail.com 
Dr Samipa J Shah  shardaben General Hospital, Saraspur, Ahmedabad  Bhagwati Nagar, Shardaben General Hospital Road, Saraspur, Ahmedabad, Gujarat – 380018.
Ahmadabad
GUJARAT 		 9898263933

dr.samipashah04@gmail.com 
Dr Sharayu Mohite  Sunanda IVF Fertility Clinic  395/2 E ward, Square 9 building Basant Bahar Rheater, Kohlapur, Maharashtra 416001
Kolhapur
MAHARASHTRA 		 9766387878

phakesharayu@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 12  
Name of Committee  Approval Status 
ACEAS - INDEPENDENT ETHICS COMMITTEE  Approved 
ACEAS - INDEPENDENT ETHICS COMMITTEE  Approved 
Annad Institutionl Ethics Committe  Approved 
Central Independent Ethics Committe  Approved 
D.Y Patil School Of medicine   Approved 
Independent Ethics Committee  Approved 
Independent Ethics Committee- Waves Women Empowerment Trust  Approved 
Institutional Ethics Committee  Approved 
Institutional Ethics Committee   Approved 
Institutional Ethics Committee JNU Institute for Medical Services & Research Centre  Approved 
Shree Vighnaharta Superspeciality Hospital Institutional Ethics Committee  Approved 
Sunrise Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N979||Female infertility, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Placebo (Maltodextrin)  Dose: 600 mg/day Regimen: One capsule (300 mg) to be taken twice a day 30 minutes post breakfast and dinner Route of administration: Oral 
Intervention  VL-GF-01  Dose: 600 mg/day Regimen: One capsule (300 mg) to be taken twice a day 30 minutes post breakfast and dinner Route of administration: Oral 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  35.00 Year(s)
Gender  Female 
Details  1.Individuals ready to give voluntary, written informed consent to participate in the study

2. Women of age between 25 to 35 years who wish to conceive

3. Women with BMI between 18.5 to 34.9 kg/m2 (both values included)

4. Women who are unable to conceive for at least one year with an unprotected sexual life

5. Women engaging in sexual act regularly and agree to continue the same at least twice a week during the study

6. Women with bilateral tubal patency as confirmed by reports (within last one year from screening) of Hysterosalpingography (HSG) or Sonosalpingography (SSG)

7. Eumenorrheic women with a regular menstrual cycle of 28 ± 5 days.

8. Women with Hemoglobin levels greater than or equal to 9. Women with Anti-Mullerian hormone (AMH) greater than 0 and less than 1.5 ng/ml on day 2 of menstrual cycle

10. Females with serum Thyroid-stimulating hormone (TSH) levels between 0.4 mIU/L to 5 mIU/L [both values inclusive] with or without medication.

11. Women who are not pregnant during the time of screening as assessed by UPT

12. Women who have never undergone IVF procedure

13. Women with their male partners having an acceptable serum analysis report as per PI

14. Women willing to complete all study-related assessments and to complete all clinical study visits as per the protocol.10 g/dL
 
 
ExclusionCriteria 
Details  1. Any chronic illness like hyper-prolactinemia

2. Females diagnosed with stage 3 and stage 4 Endometriosis

3. Females with a history of recurrent pregnancy loss (defined as ≥ 2 failed clinical pregnancies before 22 weeks of gestational age).
4. Females clinically diagnosed with Polycystic Ovarian Syndrome (PCOS).
5. Females with a prior history (within the last 6 months from screening) of ≥3 cycles of ovulation induction.
6. History of ovarian hyper-response.
7. History of any endocrine abnormality (eg: Adrenal gland disorders, pituitary disorders, endocrine diseases, dyslipidemia, etc.).
8. Females previously diagnosed with hyperparathyroidism and/or hyperthyroidism.
9. Females with a history of any psychiatric disorder.
10. Currently undergoing or have previously undergone Hormone Therapy (HT) for treatment of fertility in the previous 6 monthS
11. Currently consuming Ayurvedic/dietary supplements, and/or currently consuming steroids or if consumed in the last 3 months before screening.
12.
Currently consuming cytotoxics and immunosuppressants.
13. History of uncontrolled hypertension and/or systolic blood pressure greater than equal to 140 mmHg and/or diastolic blood pressure greater than equal to 90 mmHg.
14. Fasting blood glucose (FBG) greater than or equal to 126 mg/dL.
15. Participation in other clinical studies in the past 3 months.
16. History of alcohol or drug abuse in the 12 months prior to screening.
17. History of cancer.
18. Hematological disorders.
19. History or presence of any Sexually Transmitted Disease (STD).
20.History of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the potential individual at risk because of participation in the study
History or presence of HIV, cardiovascular, gastrointestinal, hepatic or renal disease,
or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs
22. Lactating women. 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To assess the effect of the Investigational product (IP) on time to pregnancy (TTP) as assessed by serum levels of Beta-human Chorionic Gonadotropin (Beta-hCG).  4 menstrual cycles from randomization 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the impact of the IP as compared to baseline and placebo on:
1.Ovulation status as assessed by Antral follicle count (AFC) using Transvaginal ultrasonography (TVS) [On day 2 & day 10 of each menstrual cycle]
2.Change in serum follicle-stimulating hormone (FSH) levels [On day 2 of each menstrual cycle]
3.Change in serum Estradiol levels [On day 2 & day 10 of each menstrual cycle]
4.Ovarian reserve as assessed by serum levels of Anti-Mullerian Hormone (AMH) [On day 2 of each menstrual cycle] 		 6 menstrual cycles from screening 
 
Target Sample Size   Total Sample Size="150"
Sample Size from India="150" 
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)   30/03/2025 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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   The present study is a randomized, double-blind, placebo-controlled, parallel clinical study. Approximately 156 participants will be screened, and considering a screening failure rate of 20%, not more than 124 participants will be randomized in a ratio of 1:1 to receive either Libifem® or placebo and will be assigned a unique randomization code. Each group will have not less than 50 completed participants after accounting for a dropout/withdrawal rate of 20%. 
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