A Prospective, Single-arm, Open-Label, Single-Centre Behavioural Study to Evaluate the Impact of Shilajit Supplements in increasing Quality of Life in Men

This is a prospective, single-arm, open label, single centre behavioural study to evaluate the impact of Shilajit supplements in increasing quality of life in men.

Shilajit, a sticky substance found primarily in the rocks of the Himalayas, has been used in traditional medicine for centuries. It is composed of humus and organic plant material that has been compressed by layers of rock. Shilajit is rich in fulvic acid and has an array of minerals and trace elements, making it a potent supplement.Previous studies have indicated the potential of Shilajit in improving physical performance and reducing fatigue. Its impact on cognitive functions and overall well-being, however, has not been extensively researched. This study aims to fill this gap by systematically investigating the effects of Shilajit supplementation on the quality of life in men. The study will measure various parameters such as energy levels, cognitive function, and overall well- being before and after supplementation. This research could provide a natural alternative to improve the quality of life, particularly for those who prefer or require non-pharmacological interventions.

The primary objective of the study is to assess quality of life through assessment of improvement in physical vitality, hormonal balance, cognitive function enhancement and impact on sexual health. The secondary objective will focus on assessment of improvement in sleep patterns, general immune functions and safety parameters.

The study has been approved by an Registered Independent Ethics Committee.

The eligible subjects will be enrolled into the study after obtaining informed consent by the investigator. The study will include a total of 50 participants, all of whom will receive a daily dose of 400 mg Shilajit. It is a 30-day trial and is structured into four key visits: the initial recruitment and baseline assessment on Day 1, followed by three follow-up visits on Days 10, 20, and 30. During these visits, participants will undergo assessments using scales such as the WHO-5 Well-being Index and the Montreal Cognitive Assessment (MoCA), along with self-reported questionnaires for mood and stress, and basic physical fitness tests. The subjects will be monitored throughout the study for safety and at the end of the study, the data will be analysed using the statistical tests mentioned in the protocol followed by generation of the study report.