Efficacy and Safety Of Ayurvedic Formulation For Erectile Dysfunction and Premature Ejaculatio

Not Applicable

Completed

• Conditions: Health Condition 1: R37- Sexual dysfunction, unspecified

• Registration Number: CTRI/2020/11/028782
• Lead Sponsor: DrSankalp Jain

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2022-03-15
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 100

Inclusion Criteria

Male subjects between 18 to 64 years of age.

2. Male subjects with stable, monogamous, heterosexual relationship for

at least 6 months and expected/planned to maintain this relationship

for duration of study.

3. Subjects meeting with diagnostic criteria for erectile dysfunction (as

per the international index of erectile function (IIEF) score lesser than

or equal to 25; as specified in Urology 1999, 54: 346-351).

4. Subjects meeting with diagnostic criteria for premature ejaculation

(PE score greater than or equal to 11) as specified in article published

in European Urology 2007, 52: 565-573.

5. Subject and his partner agreeing to attempt sexual intercourse 2

times/ week.

6. Subject willing to give written informed consent and willing to comply

with trial protocol.

Exclusion Criteria

1. Previous events or other conditions associated with premature

ejaculation/erectile dysfunction including but not limited to spinal

trauma or pelvic surgery.

2. Subjects with genital anatomical deformities including but not limited

to penile deformities.

3. Subjects with erectile dysfunction or premature ejaculation due

medication withdrawal.

4. Sexual dysfunction in female partner, painful intercourse, partners

with decreased interest in intercourse or other forms of sexual

dysfunction.

5. Subjects with major psychiatric illness or previous suicidal attempts.

6. Subjects with history of epilepsy

7. Subjects with history of stroke, myocardial infraction, heart failure,

unstable angina, life-threatening arrhythmia and hypotension with in

past 6 months.

8. Subjects for whom sexual activity is inadvisable because of their

underlying disease status.

9. Subject is a known case of autonomic neuropathy, retinitis

pigmentosa, bleeding disorders, sickle cell anemia and active peptic

ulcer disease.

10. Subjects with significant and uncontrolled hematological/metabolic/

endocrinologial/respiratory/cardiovascular/neurological/psychiatric

/liver/kidney diseases.

11. Subjects with resting hypotension (BP 90/50) or hypertension ( BP

170/110)

Proprietary and confidential informat

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The safety and tolerability of the investigational product will be <br/ ><br>Proprietary and confidential information Page 8 of 29 <br/ ><br>assessed by the Clinical AEs, including laboratory abnormalities <br/ ><br>Assessment Intervals Day 1 Day 35Timepoint: Day 1, Day 35

Secondary Outcome Measures

Name	Time	Method
ïâ??§Improvement Sperm concentration per milliliter of seminal fluid <br/ ><br>ïâ??§Improvement Proportion of Sperm motility <br/ ><br>ïâ??§Improvement Proportion of Sperm morphology <br/ ><br>Timepoint: Day 1, Day 35