None listed
Conditions
Interventions
Intervention1: Ashwagandha Root Extract Capsule 100 mg: Ashwagandha Root Extract Capsule 100 mg, once daily, oral for 56 days
Intervention2: Ashwagandha Root Extract Capsule 150 mg: Ashwagandha Root E
Sponsors
Inventia Healthcare Ltd
Laila Nutraceuticals
Eligibility
Inclusion criteria
Inclusion criteria: 1. Healthy adult male subjects aged between 21-45 years with a BMI between 22 and 29 kg/m2. 2. Subjects willing to be acquainted with the gym equipment for 1-2 weeks before enrolling in the study. 3. Ability to understand the risks/benefits of the protocol. 4. Subjects considered generally healthy as per health history and routine clinical investigations. 5. Subjects agree to perform physical activities as stated in the protocol in the presence of physical trainer. 6. Subjects should provide written informed consent and agree to be available for regular followup throughout the study duration. 7. Subjects agree not to start any new therapies or energy boosting supplements or protein supplements or health drinks during the study. 8. Agree to follow the dietary instructions as advised by the nutritionist during the counselling session.
Exclusion criteria
Exclusion criteria: 1. Subjects who are consuming medications that can interfere with muscle mass such as corticosteroids, testosterone replacement or anabolic drugs. 2. Concomitant administration or history of consumption within seven (7) days prior to the screening of herbal/nutraceutical/ vitamin-minerals supplements. 3. Concomitant use of any supplement including protein/amino acids/creatine/any other product used for muscle growth/recovery/ stamina and cardiorespiratory endurance. 4. Subjects using any other therapies that would affect body composition other than those revealed during the recruitment process. 5. History or presence of any cardiovascular or bronchial / airway disease including but not limited to hypertension, myocardial infarction, coronary artery disease, cardiac failure, angina, arrhythmia, bronchial asthma. 6. Clinically significant 12- Lead ECG. 7. History or presence of any chronic systemic disorder including but not limited to endocrine, neurological, hepatic or renal disease, diabetes mellitus, stroke. 8. Subjects having clinically significant abnormal findings as per investigatorâ??s discretion in the hematological and biochemical laboratory tests. 9. Human immunodeficiency virus (HIV) positive subjects.10. Subjects who consume alcohol or smoke. 11. Subjects having a history or presence of psychiatric disorder. 12. Subjects with a history of any major surgical procedure within the last 6 months. 13. The subjects who have participated in a clinical study within the last 90 days before recruitment.14. Institutionalized subjects.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Muscle strength (measured by leg extension and bench press through one repetition maximum (1 RM)) Muscle endurance (measured by leg extension and bench press through 1 RM) Cardiorespiratory endurance exercise by treadmill (maximal oxygen uptake (VO2 max))Timepoint: Change from the baseline to the end of the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Body composition by dual-energy X-ray absorptiometry (DEXA) scan (to evaluate the increase in lean muscle mass/ reduction in fat component) Serum testosterone level (free and total) Serum cortisol level Muscle damage markers in serum (creatine phosphokinase (CK) and lactate dehydrogenase (LDH) level)Timepoint: Change from the baseline to the end of the study | — |
Countries
India
Contacts
Public ContactYadvendra Singh
Cliantha Research
Outcome results
None listed