None listed
Conditions
Interventions
None listed
Sponsors
Himalaya Wellness Company
Eligibility
Inclusion criteria
Inclusion criteria: 1. 18-40 years predominantly males and fitness enthusiastic females. 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 at least 5 days in a week and willing to continue throughout the study duration. 3. Subjects who agree to perform physical activities as stated in the protocol. 4. Subjects who agree not to start any new therapies or energy boosting supplements or protein supplements or health drinks during the study. 5. Subjects who have not participated in any other similar clinical study in the last 3 months. 6. Subjects willing to sign informed consent and follow the study procedure. 7.Women of child-bearing potential must agree to use adequate contraception during study period 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.Subjects who have any physical disability which could interfere with their ability to perform the functional performance measures included in this protocol. 2.Subjects with known clinically significant neurological, respiratory, cardiovascular, gastrointestinal, hepatic, congenital or any other chronic disorder that can interfere with the study conduct in the opinion of the Investigator. 3.Subjects with known history or present condition of allergic response to any of the ingredients in the investigational product. 4.Pre-existing systemic diseases (auto immune disorders, hormonal replacement, etc.) necessitating long-term medications or any other such as bleeding disorders. 5.Pregnant as assessed by UPT & History of Amenorrhea and lactating women. 6.Known history of drug abuse/dependency that would limit ability to comprehend or follow instructions related to informed consent, treatment instructions, study procedures or follow-up guidelines. 7.Any other conditions (physical, psychological, social or uncontrolled dietary measures) that can interfere with the participant s compliance to the study in the opinion of the Investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in workout performance and muscle endurance using Push-up test. Improvement in muscle strength & muscle recovery using Hand Grip Strength test. Improvement in Energy Stamina Muscle Endurance Strength Muscle Recovery and Workout Performance through Subject Perception questionnaire.Timepoint: Visit 1: Screening/Day 1 Visit 2: Day 30 2 days Visit 3: Day 60 2 days Visit 4: Day 90 2 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Assessment of safety of Investigational Product through General Physical Examination & Laboratory Investigations. Incidence of adverse events during the study period. Assessment of GI (Gastrointestinal) tolerability through GSRS (Gastrointestinal Symptom Rating Scale). Proportion of subjects withdrawing from trial because of adverse events (tolerability).Timepoint: Visit 1: Screening/Day 1 Visit 2: Day 30 2 days Visit 3: Day 60 2 days Visit 4: Day 90 2 days | — |
Countries
India
Contacts
Public ContactDr Soorya Narayan H
Himalaya Wellness Company
Outcome results
None listed