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CTRI Number  CTRI/2009/091/000099 [Registered on: 31/03/2009]
Last Modified On: 05/03/2013
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study
Modification(s)  		 Nutraceutical 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A Triple blind, placebo controlled, randomized study to evaluate the Safety and Efficacy of VigRX Plus capsules as a dietary supplement to improve erectile function and maintain Male Sexual Health 
Scientific Title of Study   A Triple blind, placebo controlled, randomized study to evaluate the Safety and Efficacy of VigRX Plus capsules as a dietary supplement to improve erectile function and maintain Male Sexual Health 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  NIL 
Designation   
Affiliation   
Address 

Not Applicable
N/A

India 
Phone    
Fax    
Email    
 
Details of Contact Person
Scientific Query  
Name  Dr.Aliya Shakeel 
Designation   
Affiliation  Medical Writer 
Address  118-B, Morya House , Off Link Road , Andheri (W)
203- Morya Landmark -1, off link Road, Andheri (W)
Mumbai
MAHARASHTRA
400053
India 
Phone  022-42172300  
Fax  022-66941179  
Email  medical@vediclifesciences.com  
 
Details of Contact Person
Public Query  
Name  Dr.Aliya Shakeel 
Designation   
Affiliation   
Address  118-B, Morya House , Off Link Road , Andheri (W)
203- Morya Landmark -1, off link Road, Andheri (W)
Mumbai
MAHARASHTRA
400053
India 
Phone  022-42172300  
Fax  022-66941179  
Email  medical@vediclifesciences.com  
 
Source of Monetary or Material Support  
DM Contact Management Ltd. 
 
Primary Sponsor
Modification(s)  
Name  DM Contact Management Ltd  
Address  100-645 Tyee Road, Victoria,BC V9A 6X5,CANADA  
Type of Sponsor  Other [Nutraceutical Industry-Global] 
 
Details of Secondary Sponsor  
Name  Address 
NIL   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 6  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr. Manoj Chaudhari  169, Parvati gaon,   Bhaghirathi Medical Foundation,nil-400009,
Pune
MAHARASHTRA 		 9225571450
nil
nil 
Dr. Shrikant Pensalwar  Balaji Clinic  ,Main devipada Road,nil-400066

 		 9882576630
nil
nil 
Dr.Suresh Patankar  Institute of urology  Survey no. 32/2A, Erandwane,Behind Mehendale garage,Gulwani Maharaj road-411004
Pune
MAHARASHTRA 		 9881256992
Nil
NIL 
Dr.Gaurang Shah  Jivdaya Hospital   Dharmodaya Bld , Jivdaya Lane , LBS Marg , Ghatkopar (W),Nil-400086
Mumbai
MAHARASHTRA 		 91-9821019432
Nil
Nil 
Dr.Rajendra Shimpi  Noble Hospital   Magar Patta City Road , Hadapsar,NIL-411013
Pune
MAHARASHTRA 		 91-9822059799
NIL
NIl 
Dr.Vilas Sabale  Sabale Supersepciality Hospital & Stone Centre  First Floor , Vitthal Arcade, Near Rupee Bank,,PuneNashik Highway, Bhosari-411039
Pune
MAHARASHTRA 		 91-9822004630
-
- 
 
Details of Ethics Committee  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
AMAI Charitable Trust, PUne  Approved 
Independant Ethics Committee, Mumbai  Approved 
Noble Hospital Independant Ethics Committe, Pune  Submittted/Under Review 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  Sexual Health,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Placebo  2 capsules twice a day with meals for 12 weeks  
Intervention  VigRX PLus  2 capsules twice a day with meals for 12 weeks  
 
Inclusion Criteria
Modification(s)  
Age From  25.00 Year(s)
Age To  50.00 Year(s)
Gender  Male 
Details  1. Male subjects aged between 25-50 years
2. Subject having a monogamous, heterosexual relationship
3. Male subjects with IIEF-A score 11 to 23 & IIEF-B score 21 to 35 at screening visit & baseline visit
4. Subject provides written informed consent and comes for regular follow up
 
 
ExclusionCriteria 
Details  1. Subjects with major psychiatric disorders 2. Subjects having a history of stroke, myocardial infarction, coronary artery disease, cardiac failure, angina, life-threatening arrhythmia within the past 6 months. 3. Subject has a history of diabetes 4. Subject has a history of spinal cord injury or a radical prostatectomy or radical pelvic surgery. 5. Subject has an anatomical deformity of the penis which has a severe effect on sexual functioning 6. Subject is a k/c/o HIV or AIDS 7. Subject is know to suffer from STDs at screening visit 8. Subject is a chronic alcoholic showing withdrawal symptoms or subjects having medication (opiates etc) or drug (marijuana, cocaine etc)/ Nicotine/Caffeine dependence 9. Subject is using medications that are known to cause sexual dysfunction (cimetidine, spironolactone, thiazides, &#946;-adrenergic blockers, anti- depressants etc.) 10. Subject has a major illness that in the opinion of the investigator would interfere with the conduct of the study. 11. Subject has participated in a clinical drug study within the last 30 days prior to entering this study. 12. Subject with Liver dysfunction as evidenced by SGPT level of 1.5 X ULN. 13. Subject with Renal dysfunction as evidenced by Serum Creatinine level of 1.5 X ULN. 14. Subject has an abnormal thyroid stimulating hormone (TSH) level lower than 30% of LLN or more than 30% of ULN. 15. Subject has erectile dysfunction caused by neurological or endocrine factors such as hyperprolactinemia or low serum testosterone levels (<200 ng/dl). 16. Subjects already taking any medications for the study indication & do not wish to discontinue the same 17. Subject not ready to sign the consent & unable to comply with the protocol 18. Subjects whose female partners are Pregnant  
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
1- International Index of Erectile Function (SubScore A)  1- Screening , Baseline , Day 28, Day 56 , Day 84 
 
Secondary Outcome  
Outcome  TimePoints 
1-International Index of Erectile Function (Total) 2-International Index of Erectile Function (Sub Score B) 3-Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Patient & partner version 4-Semen Analysis Parameters 5-Serum Testosterone (Total) levels 6-Safety assessment parameters   1- Screening, Baseline , Day 28, Day 56 , Day 84 2- Screening, Baseline , Day 28, Day 56 , Day 84 3- Day 28 & Day 56, Day 84 (Patient) & Day 28 & Day 84 (Partner) 4- Screening & day 84 5- Screening & day 84 6- Screening, Baseline , Day 28, Day 56 , Day 84 
 
Target Sample Size
Modification(s)  		 Total Sample Size="72"
Sample Size from India="72" 
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 
Date of First Enrollment (India)   Date Missing 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  07/05/2009 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial
Modification(s)  		 Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Open to Recruitment 
Recruitment Status of Trial (India)   
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   About 72 males between 25-50 years of age will be recruited to get 60 completed/ evaluable subjects. Recruitment of subjects will be done through the investigator?s own direct contact subjects or subject referral to the selected investigators. For each subject, the study will terminate after a maximal period of 84 days from enrollment and will include 5 visits.  
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