An Open-Label, Single-Centre Behavioural study to Evaluate the Impact of Shilajit Supplements in increasing the Quality of Life in Me
- Registration Number
- CTRI/2024/02/062518
- Lead Sponsor
- Azuretale Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 50
1.Age Range: Adult males aged between 30 and 60 years.
2.Health Status: Individuals experiencing reduced vitality or cognitive issues but generally in good health.
3.Consent:Willing to provide informed consent and adhere to study protocol.
4.Availability: Able to participate in all scheduled visits and assessments during the 30- day study period.
1.Chronic Diseases: Individuals with severe chronic diseases, especially uncontrolled diabetes, cardiovascular diseases, or severe neurological disorders.
2.Current Medication: Use of cognitive enhancers, testosterone supplements, or other medications that might interfere with the study outcomes.
3.Substance Abuse: History of alcohol or substance abuse within the last six months.
4.Psychiatric Conditions: Significant psychiatric disorders that could affect compliance or skew results.
5.Other Clinical Trials: Participation in another clinical trial within the last three months.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Quality of Life improvement <br/ ><br>2.Improvement in the testosterone levels. <br/ ><br>3.Cognitive Function enhancement.Timepoint: Day 0, 10, 20 and 30
- Secondary Outcome Measures
Name Time Method 1.Improvement in Sleep Patterns. <br/ ><br>2.Assessment of General Immune functions. <br/ ><br>3.SafetyTimepoint: Day 0, 10, 20 and 30