None listed
Conditions
Interventions
None listed
Sponsors
Himalaya Wellness Company
Eligibility
Inclusion criteria
Inclusion criteria: 1. 18 to 45 years fitness enthusiastic males. 2. Athletes, sports or fitness enthusiasts engaged in regular resistance training (comprising of cardio and strength training like pushups, bench press, leg press, squats etc) from last 6 months for atleast 5 days in a week and willing to continue through out the study duration. 3. Participants who agree to perform physical activities as stated in the protocol. 4. Participants who agree not to start any new therapies or energy boosting supplements or protein supplements or health drinks during the study. 5. Participants who have not participated in any other similar clinical study in the last 3 months. 6. Participants willing to sign informed consent and follow the study procedure. 7. Men with partners of child-bearing potential must agree to use adequate contraception prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. 8. Male participants who are willing to refrain from donating sperm from first admission to the study until 90 days after the study completion.
Exclusion criteria
Exclusion criteria: 1. Participants with physical impairments or musculoskeletal conditions that would significantly interfere with their ability to safely and reliably perform the functional performance assessments specified in this protocol. 2. Participants with known or clinically significant neurological, respiratory, cardiovascular, gastrointestinal, hepatic, or other chronic medical conditions that, in the opinion of the Investigator, could compromise participant safety or interfere with study conduct or outcome interpretation. 3. Participants with a known history of allergy or hypersensitivity to any ingredient of the investigational product. 4. Participants with pre-existing systemic diseases (e.g., autoimmune disorders, bleeding disorders) or those requiring long-term pharmacological treatment, including hormone replacement therapies, that could influence study outcomes or pose a safety risk, as determined by the Investigator. 5. Participants with a known history of substance abuse or dependency that, in the opinion of the Investigator, may limit their ability to comprehend informed consent or comply with study procedures, treatment instructions, or follow-up requirements. 6. Any other medical, psychological, social, or lifestyle-related conditions, including non-standardized dietary practices, that could interfere with participant compliance or affect study outcomes, as judged by the Investigator. 7. Participants who have used performance-enhancing supplements or substances, categorized as follows: a) Short-term or acute-effect supplements (e.g., pre-workouts, stimulant-based formulations, or ergogenic aids) within 1 week prior to screening; or b) Long-term anabolic or hormone-modulating substances (including but not limited to anabolic steroids, testosterone boosters, or growth hormone) within 8 to 12 weeks prior to screening, or during the study period. 8. Participants with a history of major surgery or hospitalization within the past 3 6 months, or those not fully recovered, as judged by the Investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Endpoints: Improvement in workout performance and muscle endurance using Push-up test at Visit 2, Visit 3 & EOS compared to baseline. Improvement in muscle strength & Post workout muscle recovery using Hand Grip Strength test at Visit 2, Visit 3 & EOS compared to baseline. Supports Hormonal Regulation (Testosterone & Cortisol) ii. Subjective Endpoints: Improvement in Energy, Stamina, Endurance, Strength, Performance, Fatigue, Overall wellbeing at Visit 2, Visit 3 & EOS compared to baseline. Improvement in Post workout recovery using Likert-Type Muscle Soreness & Muscle fatigue Scale at Visit 2, Visit 3 & EOS compared to baseline.Timepoint: Day 1, Day 30, Day 56, Day 84 | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety Endpoints Incidence of adverse events Gastrointestinal Symptom Rating Scale (GSRS)Timepoint: Day 1, Day 30, Day 56, Day 84 | — |
Countries
India
Contacts
Public ContactDr Soorya Narayan H
Himalaya Wellness Company
Outcome results
None listed