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
- Conditions
- Sexual Health
- Registration Number
- CTRI/2009/091/000099
- Lead Sponsor
- DM Contact Management Ltd
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- Male
- Target Recruitment
- 72
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.
- 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 diabetes4.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 functioning6.Subject is a k/c/o HIV or AIDS7.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 dependence9.Subject is using medications that are known to cause sexual dysfunction (cimetidine, spironolactone, thiazides, ฮฒ-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 same17.Subject not ready to sign the consent & unable to comply with the protocol18.Subjects whose female partners are Pregnant.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1- International Index of Erectile Function (SubScore A) 1- Screening , Baseline , Day 28, Day 56 , Day 84
- Secondary Outcome Measures
Name Time Method 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 version4-Semen Analysis Parameters 5-Serum Testosterone (Total) levels 6-Safety assessment parameters 1- Screening, Baseline , Day 28, Day 56 , Day 842- Screening, Baseline , Day 28, Day 56 , Day 843- Day 28 & Day 56, Day 84 (Patient) & Day 28 & Day 84 (Partner) 4- Screening & day 845- Screening & day 846- Screening, Baseline , Day 28, Day 56 , Day 84
Trial Locations
- Locations (6)
169, Parvati gaon,
๐ฎ๐ณPune, MAHARASHTRA, India
Balaji Clinic
๐ฎ๐ณdevipada, India
Institute of urology
๐ฎ๐ณPune, MAHARASHTRA, India
Jivdaya Hospital
๐ฎ๐ณMumbai, MAHARASHTRA, India
Noble Hospital
๐ฎ๐ณPune, MAHARASHTRA, India
Sabale Supersepciality Hospital & Stone Centre
๐ฎ๐ณPune, MAHARASHTRA, India
169, Parvati gaon,๐ฎ๐ณPune, MAHARASHTRA, IndiaDr. Manoj ChaudhariPrincipal investigator9225571450