CTRI/2025/08/092906 [Registered on: 12/08/2025] Trial Registered Prospectively
Last Modified On:
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Ayurveda
Study Design
Single Arm Study
Public Title of Study
Clinical study on Beehj tablets in participants suffering from male infertility.
Scientific Title of Study
Clinical study to evaluate efficacy and safety of Beehj tablets in participants suffering from male infertility – An open-label, single-arm, multi-centric, non-comparative, interventional, prospective study
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
BEEHJ/GYNOVEDA/2025/, Version 1.0, 9th July 2025
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Satish R Khatal
Designation
Associate Professor
Affiliation
Bharati Vidyapeeth Deemed to Be University, College of Ayurved and Hospital.
Address
Department of Prasuti Tantra and Stree Roga OPD No-10, Ground Floor, Bharati Vidyapeeth Deemed to Be University, College of Ayurved and Hospital.
Dhanakawadi, Pune-411043, Maharashtra,
Pune MAHARASHTRA 411043 India
Phone
9970282066
Fax
Email
satish.khatal@bharatividyapeeth.edu
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 400064
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 400064
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
Gynoveda Femtech Pvt. Ltd
Access work Level-9, Eureka Tower, A-Wing Mindspace-IT Park, Chincholi Bunder
Malad West, Mumbai,
Maharashtra 400064
Type of Sponsor
Other [Healthcare Industry ]
Details of Secondary Sponsor
Name
Address
NIL
NIL
Countries of Recruitment
India
Sites of Study
No of Sites = 8
Name of Principal
Investigator
Name of Site
Site Address
Phone/Fax/Email
Dr Archana Jadhav
Ayurved Seva Sangh,Ayurved Mahavidyala,
Department of Prasuti Tantra OPD No. 5, Ground Floor, Ayurved Seva Sangh,Ayurved Mahavidyala, Ganeshwadi,. Nashik MAHARASHTRA 422003
Nashik MAHARASHTRA
7775058616
archujadhav88@gmail.com
Dr Satish R Khatal
Bharati Vidyapeeth Deemed to Be University, College of Ayurved and Hospital.
Department of Prasuti Tantra and Stree Roga
OPD No-10, Ground Floor,
Bharati Vidyapeeth Deemed to Be University, College of Ayurved and Hospital.
Dhanakawadi, Pune-411043, Maharashtra Pune MAHARASHTRA
9970282066
satish.khatal@bharatividyapeeth.edu
Dr Narendra Mundhe
KVTR Ayurvedic College and Hospital Boradi
Department of Kayachikitsa,
OPD No 5, Ground Floor, KVTR
Ayurvedic College and Hospital, Boradi, Tal. Shirpur, Dist. Dhule MAHARASHTRA 425428
Dhule MAHARASHTRA
9850378206
drnbmundhe@gmail.com
Dr Amruta Bhagwan More
Prabhankur Wellness Clinic
Department of Medicine,
OPD No.1 Ground Floor,
DSK SUNDARBAN PHASE 1, Shop No. 5, near Amanora Park Town, Main Gate, Hadapsar, Pune, Maharashtra, 411028
Pune MAHARASHTRA
7350821611
amrutam789@gmail.com
Dr Sagar Dattatray Dherange
RDM Hospital & Maternity Home
Department of Prasuti Tantra and Stri Roga,
OPD No.01, Ground floor,
RDM Hospital & Maternity Home
Gramseva Society, Wadu Chowk, Nagar Road, Koregaon Bhima, Pune, Maharashtra 412216
Pune MAHARASHTRA
83292 79770
sagardherange21@gmail.com
Dr Prasanna N Rao
SDM College of Ayurveda & Hospital
Dept. of Shalya Tantra
OPD NO. 09 Ground Floor
SDM College of Ayurveda & Hospital, Thanniruhalla, B M Road, Hassan, Karnataka 573201
Hassan KARNATAKA
Vyavahare Vitthal nam Ayurved Hospital and research Center
Department of Prasuti Tantra and Stri Roga,,
OPD no. 01, Ground floor,
Vyavahare Vitthal nam Ayurved Hospital and research Center, Plot No 79 Savera Nagar Jule Solapur, Maharashtra 413004
Solapur MAHARASHTRA
9552018980
dr.ravibhosale@gmail.com
Details of Ethics Committee
No of Ethics Committees= 8
Name of Committee
Approval Status
Institutional Ethics Committee Ayurveda Seva Sangh, Ayurveda Mahavidyalaya, Nashik
(1) Medicine Name: Beehj Tablet, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 1000(mg), Frequency: bd, Bhaishajya Kal: Samudga, Duration: 120 Days, anupAna/sahapAna: Yes(details: water), Additional Information: Subjects will be asked to take Beehj tablets in a dose of 2 tablets twice daily orally after meals for 120 days
2
Comparator Arm (Non Ayurveda)
-
NIL
NIL
Inclusion Criteria
Age From
21.00 Year(s)
Age To
45.00 Year(s)
Gender
Male
Details
1. Sperm concentration less than 16 million per ml as per WHO Laboratory Manual for the Examination and Processing of Human Semen, Sixth Edition, 2021, 13, with or without normal sperm morphology, with or without normal total motility.
2. Subjects willing to give specimen of semen, ready to observe abstinence as per requirement of protocol, and willing to provide informed consent
ExclusionCriteria
Details
1. Subjects having azoospermia, or aspermia, or necrospermia.
2. Subjects with clinical diagnosis of Varicocele & Hydrocele (If required USG with color doppler of testes will be done to confirm the diagnosis)
3. Subjects with history of undescended testis.
4. Subjects with inguinal hernia or other clinical condition on physical examination which may have relation to low sperm count
5. Subjects with accessory gland infection
6. Known cases of Diabetes Mellitus Type 2 (DM2), Uncontrolled Hypertension (HTN), Uncontrolled Thyroid dysfunction, chronic kidney disease (CKD), Liver Cirrhosis, Cardiac Ailments, psychological disorders currently on medication, epilepsy (convulsions), STDs including HIV and Hepatitis B
7. Presence of pus cells in semen (Pyospermia), absence of fructose in semen and Semen liquefaction time greater than 30 minutes, history of testicular or scrotal tumours, cysts, or obstruction
8. Subjects with severe form of sexual dysfunction and history of presence of significant alcoholism or drug abuse within the past 1 year and significant smoking (more than 10 cigarettes per day) or consumption of tobacco/nicotine products more than 10 times per day.
9. Subjects who underwent surgery within last 4 weeks or planned major surgery within next 120 days from the date of screening and subjects who have participated in any drug research study within past 3 months.
10. History of allergic reaction to any of the drug component.
11. Other conditions, which in the opinion of the investigators, makes the patient unsuitable for enrolment or could interfere with his participation in, and completion of the protocol.
1. Changes in sperm morphology, erectile function, sexual desire, energy levels
2. Assessment of premature ejaculation
3. Changes in hormonal regulation of spermatogenesis
4. Spontaneous achieved pregnancies
5. Adverse events and vitals and laboratory investigations
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)
25/08/2025
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="8" 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
It is a clinical
study to evaluate efficacy and safety of Beehj tablets in participants
suffering from male infertility. The study will be conducted at 8 to 10 centers
in India. The primary objective of the
study will be to assess change in sperm count and motility. The
secondary objectives of the study will be to assess changes in sperm morphology,
erectile function, sexual desire, energy levels, premature ejaculation, changes
in hormonal regulation of spermatogenesis, spontaneous achieved pregnancies, adverse
events and vitals and laboratory investigations on Screening Visit (Up to 5
days), Baseline visit (Day 0), Visit 1, (Day 30), Visit 2 (Day 60), Visit 3
(Day 90), Visit 4 (Day 120)