Health Condition 1: F430- Acute stress reaction Health Condition 2: N528- Other male erectile dysfunction
Conditions
Interventions
Intervention1: Vitality Booster Capsules: Vitality Booster Capsules is a nutraceutical product, formulated as a capsule which has Ashwagandha Extract, Proprietary Terminalia Blend and Sarpagandha (2%
Sponsors
Amitojas Wellness Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male subjects aged >= 18 years and 2. Subjects who are experiencing mild to moderate stress; stress score >=15 to 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| DASS-21 score documented in the CRF at baseline, day 15, and day 30 (values and change from baseline - within the group and between the groups comparisons)Timepoint: baseline, day 15, and day 30 | — |
Secondary
| Measure | Time frame |
|---|---|
| Serum Cortisol levels documented in the CRF at baseline, and day 30 (values and change from baseline - within the group and between the groups comparisons)Timepoint: baseline and day 30;Serum Testosterone levels documented in the CRF at baseline, and day 30 (values and change from baseline - within the group and between the groups comparisons)Timepoint: baseline and day 30;36 item Short Form Survey (SF-36) domain scores documented in the CRF at baseline and day 30 (values and change from baseline - within the group and between the groups comparisons)Timepoint: baseline and day 30;International Index of Erectile Function (IIEF) domain scores documented in the CRF at baseline and day 30 (values and change from baseline - within the group and between the groups comparisons)Timepoint: baseline and day 30 | — |
Countries
India
Contacts
Public ContactMr Kamal Kammili
Amitojas Wellness Private Limited
Outcome results
None listed