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CTRI Number  CTRI/2018/10/016090 [Registered on: 22/10/2018] Trial Registered Prospectively
Last Modified On: 06/12/2019
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Single Arm Study 
Public Title of Study   Clinical Study on D-Frag Tablets for improving Sperm Quality (Sperm DNA) 
Scientific Title of Study   An Open Label, Prospective, Non-Comparative, Single Arm Clinical Study to Evaluate the Efficacy and Safety of D-Frag Tablets in the Treatment of Sperm DNA Fragmentation in Adult Men to Aid Conception.  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
AHC/INF/043/18 Version 01 02-Jul-18  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr VT Sriraam 
Designation  Chief Medical Research Coordinator 
Affiliation  Aurous HealthCare R & D India Private Limited 
Address  180/109, G1 and G2, RR Villa, Rangarajapuram Main Road, Kodambakkam

Chennai
TAMIL NADU
600024
India 
Phone  9840909155  
Fax    
Email  md@auroushealthcare.com  
 
Details of Contact Person
Scientific Query  
Name  Dr VT Sriraam 
Designation  Chief Medical Research Coordinator 
Affiliation  Aurous HealthCare R & D India Private Limited 
Address  180/109, G1 and G2, RR Villa, Rangarajapuram Main Road, Kodambakkam


TAMIL NADU
600024
India 
Phone  9840909155  
Fax    
Email  md@auroushealthcare.com  
 
Details of Contact Person
Public Query  
Name  Dr VT Sriraam 
Designation  Chief Medical Research Coordinator 
Affiliation  Aurous HealthCare R & D India Private Limited 
Address  180/109, G1 and G2, RR Villa, Rangarajapuram Main Road, Kodambakkam


TAMIL NADU
600024
India 
Phone  9840909155  
Fax    
Email  md@auroushealthcare.com  
 
Source of Monetary or Material Support  
Nutri Synapzz Therapeutix Private Limited 
 
Primary Sponsor  
Name  Nutri Synapzz Therapeutix Private Limited 
Address  No. 203, 2nd Floor, BEML, IV Stage, Raja Rajeshwari Nagar, Bangalore Karnataka, India - 560 098. 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
Aurous HealthCare Research and Development India Private Limited  180/109, G1 and G2, RR Villa, Rangarajapuram Main Road, Kodambakkam, Chennai - 600024 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Kshitiz Murdia  Indira IVF Hospital Private Limited  Department of Infertility Number 44,Amar Niiwas,Opposite MB College, Kumharo ka bhatta ,Udaipur 313001 Rajasthan, India.
Udaipur
RAJASTHAN 		 9799112244

drkshitiz@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Human Research Ethics Committee, Geetanjali Medical College and Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N469||Male infertility, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  DFrag Tablets  Intended for the treatment of Male Infertility (Sperm DNA Fragmentation). Dosage: 1 tablet, twice a day for 3 months. 
Comparator Agent  Not Applicable  Non comparative study 
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  99.00 Year(s)
Gender  Male 
Details  Male subjects above the age of 21 years, in a monogamous, heterosexual marriage, trying to conceive but having difficulty with conception.
2. Subjects with Sperm DNA Fragmentation Index ≥15% at the time of screening.
3. Subjects with normal or clinically non-normal seminal parameters not limited to hemospermia, leucospermia.
4. Subjects whose female partners have not conceived after 1 year of unprotected vaginal sexual intercourse; with or without history of ART treatments.
5. Subjects with primary or secondary infertility.
6. Subjects who are willing to commit to study restrictions not limited to abstinence from masturbation and sexual intercourse for specific periods. 
 
ExclusionCriteria 
Details  Subjects who have aspermia, azoospermia, cryptozoospermia.
2. Subjects who have history/diagnosis of cancer inclusive of subjects in remission.
3. Subjects with testicular atrophy and congenital abnormalities not limited to absence of vas deferens.
4. Subjects who are currently on or were on a antioxidant and/or vitamin supplements upto 3 months prior to screening.
5. Subjects with history of substance abuse.
6. Subjects with diagnosis of HIV, HCV, HBV and other sexually transmitted diseases.
7. Subjects with known history of clinically significant, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, neurological abnormalities or diseases.
8. Subjects who have undergone major surgical procedure 4 weeks prior to screening.
9. Subjects who are on steroids, hormone therapy, anti-depressants, anti-psychotics.
10.Subjects who have participated in another clinical study upto 3 months prior to screening.
11. Subjects who mentally unable to comprehend the responsibilities and adhere to the stipulations of the protocol.
12. Subjects who in the opinion of the investigator are deemed unfit to participate in the study. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1. Sperm DNA Fragmentation Index : Reduction of ≥5% DFI from baseline to end of study.
2. Sperm DNA Fragmentation Index : Reduction of ≥10% DFI from baseline to end of study.
3. Sperm DNA Fragmentation Index : ≤15% DFI by end of study,provided that the reduction is ≥5% DFI.
4. Subject Compliance and Satisfacation: Score of ≥ 20 by end of study.
 		 1. Sperm DNA Fragmentation Index: At Visit 0( Day 0), Visit 3 (Day 90).
2. Subject Compliance and Satisfacation:At Visit 2(Day 45), Visit 3 ( day 90). 
 
Secondary Outcome  
Outcome  TimePoints 
1. Sperm DNA Fragmentation Index : Reduction of 3-4% DFI from baseline to end of study.
2. Subject Compliance and Satisfacation: Score of 15-19 by end of study.
 		 1. Sperm DNA Fragmentation Index: At Visit 0( Day 0), Visit 3 (Day 90).
2. Subject Compliance and Satisfacation:At Visit 2(Day 45), Visit 3 ( day 90).
 
 
Target Sample Size   Total Sample Size="66"
Sample Size from India="66" 
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)   30/10/2018 
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="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   Not applicable.  
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Study Design:  An Open Label, Prospective, Non-Comparative, Single Arm Clinical Study.

Study Population: Males above the age of 21 years in a monogamous, heterosexual marriage, trying to conceive but having difficulty with conception. 

Indication: Male Infertility (Sperm DNA Fragmentation)

Investigational Product Test: DFrag Tablets

Investigational Product Comparator: None. (Non-comparative, single arm study)

Dosage: 1 BD x 3 months (1 tablet in the morning and 1 tablet in the night for 3 months)

Study Duration: 3 months

Number of Subjects: 66 subjects (so as to reach 60 evaluable subjects)

Assessments:

1. Sperm DNA Fragmentation Index

2. Subject IP Feedback Questionnaire

3. Complete Blood Count

4. Serum Biochemistry (including LFT and RFT)

 


 
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