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

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2009/091/000099
• Date of registration: 31-03-2009
• Prospective Registration: Yes
• Primary sponsor: DM Contact Management Ltd
• Public title: 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: 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
• Date of first enrolment: 07-05-2009
• Target sample size: 72
• Recruitment status: Open to Recruitment
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=365
• Study type: Interventional
• Study design: Randomized, Parallel Group, Placebo Controlled Trial; Method of generating randomization sequence:Coin toss, Lottery, toss of dice, shuffling cards etc Method of allocation concealment:Pre-numbered or coded identical Containers Blinding and masking:Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
• Phase: Phase 2

Countries of recruitment

India

Contacts

• Name: Dr.Aliya Shakeel
• Affiliation: Medical Writer

• Name: Dr.Aliya Shakeel
• Affiliation: Medical Writer

Key inclusion & exclusion criteria

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


Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Health Condition 1: null- Sexual Health

Intervention(s)

Intervention1: VigRX PLus: 2 capsules twice a day with meals for 12 weeks
Control Intervention1: Placebo: 2 capsules twice a day with meals for 12 weeks

Primary Outcome(s)

1- International Index of Erectile Function (SubScore A)Timepoint: 1- Screening , Baseline , Day 28, Day 56 , Day 84

Secondary Outcome(s)

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 parametersTimepoint: 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

Secondary ID(s)

NIL

Source(s) of Monetary Support

DM Contact Management Ltd.

Ethics review

Status: Approved
Approval date:
Contact:

AMAI Charitable Trust, PUne

Status: Approved
Approval date:
Contact:

Independant Ethics Committee, Mumbai

Status: Not Approved
Approval date:
Contact:

Noble Hospital Independant Ethics Committe, Pune