CTRI/2025/11/097011 [Registered on: 06/11/2025] Trial Registered Prospectively
Last Modified On:
17/01/2026
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Ayurveda
Study Design
Single Arm Study
Public Title of Study
Clinical Study on Gynoveda Ayurvedic Formulations in Female Infertility
Scientific Title of Study
An Open-Label, Single-Arm, Multicentric, Prospective Clinical Study to Evaluate Efficacy and Safety of Gynoveda Ayurvedic Formulations (Poshini along with Upaja and Rutuja) in Female Infertility
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
PUR/GYNOVEDA/FI/2025/1, Version 1.0, 28th Sept 2025
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Amit Apparao Khamitkar
Designation
Obstetrician and Gynaecological Consultant Physician
Affiliation
Shripad Multi Specialty Hospital
Address
Department of Obs and Gyno, OPD no.2, Second Floor
Shripad Multi Specialty Hospital Kate square building. Kate Puram chowk. Pimple Gurav. Pune. Pimpri-Chinchwad Maharashtra
Pune MAHARASHTRA 411061 India
Phone
7875266265
Fax
Email
dramitkhamitkar.ivora@gmail.com
Details of Contact Person Scientific Query
Name
Dr Sanjay Tamoli
Designation
Director
Affiliation
Target Institute of Medical Education and Research Pvt. Ltd
Address
Target Institute of Medical Education and Research Pvt. Ltd A wing 402 A/B/C, Jaswanti Allied Business Center,
Ramchandra Lane Extension,
Kachpada, Malad West, Mumbai
Mumbai (Suburban) MAHARASHTRA 400064 India
Phone
9322522252
Fax
Email
targetinstitute@yahoo.com
Details of Contact Person Public Query
Name
Dr Sanjay Tamoli
Designation
Director
Affiliation
Target Institute of Medical Education and Research Pvt. Ltd
Address
Target Institute of Medical Education and Research Pvt. Ltd A wing 402 A/B/C, Jaswanti Allied Business Center,
Ramchandra Lane Extension,
Kachpada, Malad West, Mumbai
MAHARASHTRA 400064 India
Phone
9322522252
Fax
Email
targetinstitute@yahoo.com
Source of Monetary or Material Support
Gynoveda Femtech Pvt. Ltd
Access work Level-9, Eureka Tower,
A-Wing Mindspace-IT Park, Chincholi Bunder
Malad West, Mumbai,
Maharashtra 400064
Primary Sponsor
Name
Gynoveda Femtech Pvt. Ltd
Address
Access work Level-9, Eureka Tower, A-Wing Mindspace-IT Park, Chincholi Bunder
Malad West, Mumbai,
Maharashtra 400064
Department of Streerog and Prasutitantra, OPD No. 05, Ground floor
Ganeshwadi, Nashik -422003
Nashik MAHARASHTRA
7775058616
archujadhav88@gmail.com
Dr Divya Ramugade
D. Y. Patil Deemed to be University, School of Ayurveda
Department of Streerog and Prasutitantra, OPD No. 1, 1st Floor, Sector, 7, Nerul Navi Mumbai 400706 Mumbai (Suburban) MAHARASHTRA
9324446071
divya.ramugade@dypatil.edu
Dr Gayathri Bhat NV
SDM College of Ayurveda and Hospital
Department of Streerog and Prasutitantra, OPD No. 1, 1st Floor, Bangalore - Mangalore Hwy, Thanniruhalla, Hassan, Karnataka 573201 Hassan KARNATAKA
9844437917
gaya3hassan@gmail.com
Dr Avinash Deore
Shree Sai Ayurvedic Panchakarma Rugnalaya
Department of Medicine, OPD no.1, Floor no 2nd
Shree Sai Ayurvedic Panchakarma Rugnalaya
2nd Floor, Kohinoor Arcade, Bus Stop, Sector No. 24, Pradhikaran, Nigdi, Pune, Pimpri-Chinchwad, Maharashtra 411044 Pune MAHARASHTRA
9822634478
dravinashdeore2014@gmail.com
Dr Amit Apparao Khamitkar
Shripad Multi Specialty Hospital
Department of Obs and Gyno, OPD no.2, Second Floor
Shripad Multi Specialty Hospital Kate square building. Kate Puram chowk Pimple Gurav. Pune. Pimpri-Chinchwad Maharashtra 411061 Pune MAHARASHTRA
(1) Medicine Name: Poshini, Tab. Upaja and Tab Rutuja, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 2(NA), Frequency: bd, Bhaishajya Kal: Samudga, Duration: 120 Days, anupAna/sahapAna: No, Additional Information: Subjects will be instructed to take Tab. Poshini and Tab. Upaja at a dose of 2 tablets each, twice daily, orally after meals with water, for a duration of 120 days. Additionally, in participants where timely ovulation (egg rupture) does not occur (as identified in the previous menstrual cycle) Tab. Rutuja will be administered at a dose of 2 tablets twice daily from Day 6 to Day 16 of each menstrual cycle (only if ovulation is absent or suboptimal, as confirmed by follicular monitoring).
If a subject achieves consecutive three ovulations during the course of the study, all study medications (Poshini, Upaja, and Rutuja) will be discontinued immediately
1. Married female participants diagnosed with primary or secondary infertility
2. Menstrual cycle- 21 to 35 days
3. History of miscarriage or habitual abortion, provided it occurred more than one year prior to enrolment
4. Acceptable ultrasound (USG) findings: Simple cysts less than 2 cm, hemorrhagic cysts less than 2 cm, follicular cysts less than 2 cm, intramural and sub serosal fibroids less than 2 cm in size.
5. Serum AMH levels between 1to 4 ng per mL with baseline ovulation may be positive or negative
6. Ability to have regular intercourse during the ovulation induction phase of the study
ExclusionCriteria
Details
1. Current pregnancy
2. Subjects having organic causes of menstrual abnormalities like uterine myeloma, pelvic inflammatory disease adenomyosis, polyps, fibroids greater than 2 cm, endometriosis, cervical erosion, Ovarian cysts greater than 2 cm, (as diagnosed by USG lower abdomen and pelvis).
3. All submucosal fibroids to be excluded from the study
4. Pelvic inflammatory disease (PID), miscarriage within the last 1 year
6. History of positive for sexually transmitted infections: HIV, Hepatitis A, B, or C
7. Liver cirrhosis, chronic kidney disease, or other severe systemic illnesses
8. TORCH positive
9. All cases of hyperprolactinemia, whether controlled with medicine or not, will be excluded.
10. Known causes of infertility (e.g., tubal blockage, male factor infertility, PCOD, endometriosis, etc.
11. Current use of hormonal treatment or ovulation induction agents
12. Other known cause of infertility: endometriosis, tubal factor, uterine abnormalities
13. Uncorrected thyroid disease
14. Any systemic illness or condition affecting fertility
15. Medical conditions in which avoiding pregnancy is recommended until under improved control: poorly controlled Type 1 or Type 2 diabetes, poorly controlled hypertension.
16. Use of medications known to affect reproductive function or metabolism or that are an absolute contraindication during pregnancy within the past month.
17. Participants not willing to attempt conception during the study period
18. Use of any other investigational drug within 1 month prior to screening visit.
19. Subjects having known hypersensitivity to any ingredient of the study drug.
20. Any other condition which in the opinion of investigator would have placed the subject at risk or would have influenced the conduct of study or interpretation of results
1. Assessment of Largest Developing Follicle
2. Change in endometrial thickness
3. Number & percentage of participants who report conception
4. Change in serum AMH
5. Global assessment for overall change
6. Tolerability of study medications
7. Adverse events, clinical symptoms, signs, vitals & laboratory tests
Screening Visit (Day up to 5 If needed), Baseline Visit (Day 0), Visit I (Day 30), Visit II (Day 60), Visit III (Day 90), Visit IV (Day 120)
Target Sample Size
Total Sample Size="200" Sample Size from India="200" 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/ Phase 3
Date of First Enrollment (India)
20/11/2025
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)?
It is an open-label, single-arm, multicentric, prospective clinical study to evaluate efficacy and safety of Gynoveda Ayurvedic Formulations (Poshini along with Upaja and Rutuja) in Female Infertility. The study will be carried out at 10 to 12 centers in India. Subjects will be instructed to take Tab. Poshini and Tab. Upaja at a dose of 2 tablets each, twice daily, orally after meals with water, for a duration of 120 days. Additionally, in participants where timely ovulation (egg rupture) does not occur (as identified in the previous menstrual cycle) Tab. Rutuja will be administered at a dose of 2 tablets twice daily from Day 6 to Day 16 of each menstrual cycle (only if ovulation is absent or suboptimal, as confirmed by follicular monitoring). If a subject achieves consecutive three ovulations during the course of
the study, all study medications (Poshini, Upaja, and Rutuja) will be
discontinued immediately. Primary objective will be to assess number of participants achieving Ovulation based on follicular study. The secondary objectives of the study will be to assess largest Developing Follicle (Dominant follicle), change in endometrial thickness, number and percentage of participants who report conception (A positive test of serum Beta hCG), change in serum AMH, global assessment for overall change as assessed by participants and investigator, tolerability of study medications as assessed by participants and investigator and safety evaluation by assessing adverse events, clinical symptoms, signs, vitals and laboratory tests on Screening Visit (Day up to 5 If needed), Baseline Visit (Day 0), Visit I (Day 30 + 5 days), Visit II (Day 60 + 5 days), Visit III (Day 90 + 5 days), Visit IV (Day 120 + 5days).