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

Phase 2

• Conditions: Health Condition 1: null- Sexual Health

• Registration Number: CTRI/2009/091/000099
• Lead Sponsor: DM Contact Management Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 72

Inclusion Criteria

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

Exclusion Criteria

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, β-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

Study & Design

• Study Type: Interventional
• Study Design: Not specified