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CTRI Number  CTRI/2020/12/029590 [Registered on: 04/12/2020] Trial Registered Prospectively
Last Modified On: 07/06/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Clinical study of Oligocare Forte Plus versus placebo in sub-fertile males. 
Scientific Title of Study   A prospective, randomized, double blind, placebo controlled, parallel arm study to assess the efficacy & safety of Oligocare Forte Plus versus placebo in sub-fertile males. 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
MHC/CT/20-21/020 (Version 2.0 dated, 21st Nov 2020)  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DR AMEET PATKI 
Designation  Principle Investigator 
Affiliation  Fertility Associates- Centre For Assisted Reproduction 
Address  Fertility Associates Centre OPD 1, 4th Floor Gupte House Near Khar Police Station 81, S V Road, Khar West Mumbai

Mumbai (Suburban)
MAHARASHTRA
400054
India 
Phone  02226044333  
Fax    
Email  ameetpatki@fertilityassociates.in  
 
Details of Contact Person
Scientific Query  
Name  Ms Tania Dcruz 
Designation  Medical Executive (Medical Services) 
Affiliation  Meyer Organics Pvt. Ltd. 
Address  Department of Medical Services First Floor, A-303, Road No. 32, Wagle Estate, Thane, Mumbai

Mumbai (Suburban)
MAHARASHTRA
400604
India 
Phone  02225817126  
Fax  062757002  
Email  tdcruz@meyer.co.in  
 
Details of Contact Person
Public Query  
Name  Mr Sunil Kulkarni 
Designation  Manager (R&D) 
Affiliation  Meyer Organics Pvt. Ltd. 
Address  Department of R&D, Ground floor, A-303, Road No. 32, Wagle Estate, Thane, Mumbai

Mumbai (Suburban)
MAHARASHTRA
400604
India 
Phone  02225817060  
Fax  062757002  
Email  sakulkarni@meyer.co.in  
 
Source of Monetary or Material Support  
Meyer Organics Pvt. Ltd. A-303, Road No. 32, Wagle Estate, Thane – 400 604 (Mumbai), Maharashtra, INDIA. 
 
Primary Sponsor  
Name  Meyer Organics Pvt Ltd 
Address  A-303, Road No. 32, Wagle Estate, Thane -400 604. 
Type of Sponsor  Pharmaceutical industry-Indian 
 
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 Venugopal M  ARMC IVF Fertility Centre  Ayyanthole ground, Thrissur, Kerala-680003
Thrissur
KERALA 		 9846070109

venuivf@gmail.com 
Dr Gautam Khastgir  Bengal Infertility & Reproductive Therapy Hospital (BIRTH)  36B, Elgin Road, Kolkata, India
Kolkata
WEST BENGAL 		 9830067589

birthindia@gmail.com 
Dr Ameet Patki  Fertility Associates- Centre for Assisted Reproduction  4th Floor Gupte House Near Khar Police Station 81, S V Road, Khar West Mumbai 400054
Mumbai (Suburban)
MAHARASHTRA 		 02226044333

ameetpatki@fertilityassociates.in 
Dr Priya Kannan  Garbba Rakshambigai Fertility Centre  4, 6th Cross Street, United India, Kodambakkam, Chennai 600024
Chennai
TAMIL NADU 		 9840391331

kaypriya2000@gmail.com 
Dr Bavin  Global Medical Solutions  Kanate Tower, 2nd Floor, Jaffer khan colony Road, Kozhikode, Kerala 673004
Kozhikode
KERALA 		 9847916308

bavinb@gmail.com 
Dr Monica Singh  Infertility Specialist and Endoscopist  Bhopal Test-tube-baby and Endoscopy Centre E-1/13A, Arera Colony Bhopal - 462016
Bhopal
MADHYA PRADESH 		 9200002833

bttbcentre@gmail.com 
Dr Shashikant Umbardand  Mangalya Nursing Home & Atharva Fertility Centre  738, 739 & 740, Near Kali Masjid, South Kasba, Solapur - 413002.
Solapur
MAHARASHTRA 		 9867082320

shashikant.umbardand@gmail.com 
Dr Apoorva Pallam Reddy  Phoenix Specialty clinic  1st floor, N072 TSN Arcade, 28th main road, 9th Block Jayanagar Bangalore-560069
Bangalore
KARNATAKA 		 9886919887

apoorvap_reddy@yahoo.co.in 
Dr Srilatha Gorthi  Revive Clinic  Concrete cornet, Huda trade centre, Serilingampally, Hyderabad Telangana-500019
Hyderabad
TELANGANA 		 9849167867

srilathagorthi@gmail.com 
Dr Sabine S  Sabine Hospital & Research Centre Pvt. Ltd  12/58 Pezhakkappilly, Ernakulam Kerala- 686673
Ernakulam
KERALA 		 9656011713

drsabine10@gmail.com 
Dr Sweta Agarwal  Southern Gem Hospital  5-9-30/1/7, Gowri Parmeshwari Mansion, Place Colony, Basheerbagh, Hyderabad-500063
Hyderabad
TELANGANA 		 9603890556

drsweta.agarwal@yahoo.com 
Dr Anita Kulshreshtha  Yashlok hospital  43A/31A Hashimpur Road, PrayagRaj, India
Allahabad
UTTAR PRADESH 		 9936664999

kapil_anita@yahoo.co.uk 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 12  
Name of Committee  Approval Status 
Royal Pune Independent Ethics Commitee  Approved 
Royal Pune Independent Ethics Commitee  Approved 
Royal Pune Independent Ethics Commitee  Approved 
Royal Pune Independent Ethics Committee  Approved 
Royal Pune Independent Ethics Committee  Approved 
Royal Pune Independent Ethics Committee  Approved 
Royal Pune Independent Ethics Committee  Approved 
Royal Pune Independent Ethics Committee  Approved 
Royal Pune Independent Ethics Committee  Approved 
Royal Pune Independent Ethics Committee  Approved 
Royal Pune Independent Ethics Committee  Approved 
Royal Pune Independent Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N461||Oligospermia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Oligocare Forte Plus Tablets  Oligocare Forte Plus Tablets 1 tablet daily after meal for 90 days 
Comparator Agent  Placebo tablet  1 tablet daily after meal for 90 days 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  45.00 Year(s)
Gender  Male 
Details  Willingness to provide written informed consent to participate in the study and willing to follow up.
The female partner was defined as being fertile
Semen analysis indicating any 2 of the following criteria-
Semen volume <1.5ml
Sperm count < 15 x 106/ml
Motile count< 25% /106ml should read as Motile count <25%
Abnormal morphology < 4% normal form.
DNA fragmentation >20%
Subjects with Oligospermia, Asthenospermia, Teratospermia
Female partners of the male subjects with reported pre-existing fertility disorders can still be considered. 
 
ExclusionCriteria 
Details  General and endocrinological disease (clinical examination and routine
hormonal laboratory tests)
Previous or present cryptorchidism or genital obstruction.
H/o Vasectomy, undescended testis, prostate cancer, varicocele, hydrocele.
H/o chemotherapy or radiation for malignant conditions.
H/o Azoospermia 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
To evaluate safety and efficacy of Oligocare Forte Plus by assessing-
Total sperm count in sub-fertile male.
Reduction in DNA Fragmentation in sub fertile male.  		 Baseline to end of study i.e. day 90 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate safety and efficacy of Oligocare Forte Plus by assessing following parameters in sub fertile male-
Total semen volume
Sperm motility
Sperm morphology
Overall pregnancy incidence amongst the study couple
 		 Baseline to end of study i.e. day 90 
 
Target Sample Size   Total Sample Size="300"
Sample Size from India="300" 
Final Enrollment numbers achieved (Total)= "300"
Final Enrollment numbers achieved (India)="300" 
Phase of Trial   Post Marketing Surveillance 
Date of First Enrollment (India)   06/12/2020 
Date of Study Completion (India) 18/03/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="5"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  

Male factor infertility accounts for up to half of all cases of infertility and affects one man in 20 in the general population. Evidence now suggests that reactive oxygen species (ROS)-mediated damage to sperm is a significant contributing pathology in 30–80% of cases. ROS, defined as including oxygen ions, free radicals, and peroxides, cause infertility by two principal mechanisms. First, ROS damage the sperm membrane which in turn reduces the sperm’s motility and ability to fuse with the oocyte. Secondly, ROS directly damage sperm DNA, compromising the paternal genomic contribution to the embryo. Elevated homocysteine has been linked with oxidative stress. Considering possible beneficial effects of Oligocare Forte Plus it is believed to be useful in the treatment of subfertility in males. Taking leads from nutraceutical principles, Meyer Organics Pvt. Ltd. has developed “Oligocare Forte Plus”, for the effective management of subfertility in males. This possesses spermatogenetic activity also helps increase secretion of androgens, reduce free radicals, nourish sperm, decrease stress, and promote overall wellbeing. The present clinical study titled “A prospective, randomized, double-blind, placebo-controlled, parallel-arm study to assess the efficacy & safety of Oligocare Forte Plus versus placebo in sub-fertile males.” is planned in 300 subjects.

 
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