A clinical study to evaluate Vitality Booster Capules for the management of stress and improvement of vitality

Phase 4

• Conditions: Health Condition 1: F430- Acute stress reactionHealth Condition 2: N528- Other male erectile dysfunction

• Registration Number: CTRI/2020/10/028656
• Lead Sponsor: Amitojas Wellness Private Limited

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: 0

Inclusion Criteria

1. Male subjects aged >= 18 years and <= 60 years.

2. Subjects who are experiencing mild to moderate stress; stress score >=15 to <= 25 as per 21 item Depression, Anxiety, Stress Scale (DASS-21) at screening

3. Subjects with score 11 to 25 on the Erectile Function (EF) domain of the International Index of Erectile Function (IIEF) at screening visit.

4. Subjects should be in an active stable sexual relationship for the entire duration of study

5. Subjects willing to provide informed written consent.

Exclusion Criteria

1. Subjects with significant medical/surgical condition which requires long-term treatment.

2. Subjects with anatomical abnormalities of the penis.

3. Subjects who are currently being treated with other anti-stress and/or erectile dysfunction drugs.

4. Alcohol or substance abuse

5. Allergy or sensitivity to any of the ingredients in the study treatment

6. Subjects who have participated in other clinical studies during the past 3 months or subjects who intend to participate in other clinical studies parallelly.

7. Subjects with any other illness or health condition which in the opinion/medical judgement of the study investigator makes the subject ineligible to participate in the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified