Treatment for male Impotency
- Conditions
- Health Condition 1: null- 104 patients with Male Impotency, meeting all inclusion/exclusion criteria will be included for the study
- Registration Number
- CTRI/2017/10/009962
- Lead Sponsor
- MB Life Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
1.Subjects with Male Impotency fulfilling the diagnostic criteria of IIEF-15
2.Subjects with signs & symptoms of Klaibya
3.Male subjects with age between 21-45 years
4.Willing to give consent for participating in the study
1.Subjects with H/o BPH, Severe HTN & cardiac disease
2.Sexually transmitted diseases.
3.Patients with other major systemic disorders which interfere with the treatment will be excluded
4.Known case of genetic abnormalities.
5.Patients with known major psychological disorders.
6.Spinal injury and major pelvic surgery.
7.Pyeronieâ??s disease.
8.Priapism.
9.Any other conditions which in the opinion of investigator will place the subject at risk or will influence the conduct of study or interpretation of results
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate the efficacy of capsule Vatsyayan plus in the management of male impotencyTimepoint: Day -1,0,1-30,30,60
- Secondary Outcome Measures
Name Time Method To evaluate the efficacy of capsule Vatsyayana plusTimepoint: Safety Parameters such as CBC, LFT, and RFT will be done on 0th and 30th day in 50% of subjects. <br/ ><br>Efficacy (Primary): <br/ ><br>(Before and after the treatment period of 30 days) <br/ ><br>Changes in following parameters between day 1 and day 30: <br/ ><br> Subjective parameters: IIEF -15 Questionnaire <br/ ><br> Objective parameters: Testosterone, FSH, LH, semen analysis