None listed
Conditions
Interventions
Intervention1: (Ashwa SR) 300 mg capsules: 1 capsule of ProlanzaTM (Ashwa SR) 300 mg capsules to be orally administered with water once daily after breakfast for duration of 90 Days
Control Interventi
Sponsors
Nutriventia Limited
Laila Nutraceuticals
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and female subjects aged between 25-50 years (both inclusive) who are recreationally active and gym going subjects who are at the initial stages of their strength training (less than 1 month). 2. Subjects within the BMI range of 25.0 to less than 29.9 kg/m . 3. Healthy subjects as determined by: Medical history, Physical examination, and clinical judgment of the investigator. 4. Female subjects of childbearing potential must be using a medically acceptable form of birth control. Female subjects of non-childbearing potential must be amenorrheic for at least 1 year or had a hysterectomy and/or bilateral oophorectomy 5. Results of screening procedures and lab investigations are within normal range or considered not clinically significant by the Principal Investigator. 6. Subjects who are not dependent on tobacco products alcohol consumption or any other substance abuse and are agreeing to refrain from alcohol, tobacco products and other substances of abuse during the study. 7. Subjects who agree to refrain from any kind of supplements (protein and metabolism supplements, steroids etc) that enhance muscle strength and performance. 8. Subjects who agree to maintain normal diet without any major amplifications or modifications during the study. 9. Subjects who agree to be consistent with their workout regimen (must attend the gym/fitness session for 5 continuous days of a 7-day week with alternating days of resistance training and aerobic training culminating with 2 days of rest) and willing to include bench press, leg extension and treadmill in their regimen. 10. Subjects who agree to abide by the conditions of the study protocol and are willing to sign the informed consent and comply with study procedure.
Exclusion criteria
Exclusion criteria: 1. Subjects younger than 25 years or older than 50 years. 2. Female subjects who are pregnant, breast-feeding or who are planning to become pregnant during the study. 3. Subject with hypersensitivity to any of the ingredients of the study products. 4. Subjects with any significant uncontrolled systemic illness (including but not limited to uncontrolled hypertension, chronic renal disease, chronic liver disease, poorly controlled diabetes mellitus, congestive heart failure, coronary artery disease, STDs, musculoskeletal disorders etc.). 5. Concurrent use of supplements for stress/anxiety/sleep/any other indications, herbal or pharmaceutical preparations. 6. Subjects who are concurrently using medication or steroids to enhance physical performance. 7. Subjects who are on any medication/treatment for infertility/enhancement of sexual function within 6 months prior to study enrolment. 8. Subjects who are alcohol dependent. 9. Subjects who are inconsistent with their workout regimen. 10. Subjects with a weight loss of more than 5 kg in the previous 3 months, 11. Subjects with any history of drug abuse, smoking cigarettes or consuming any tobacco products or alcohol. 12. Subjects with history of any orthopedic injury or surgery within the previous 6 months, 13. Participation in other clinical studies during the previous 3 months. 14. Difficulty in swallowing and retaining oral formulation. 15. Subjects who are not willing or unable to provide blood samples for study related evaluations. 16. Any condition that in opinion of the Investigator, does not justify the Subjects participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in muscle strength in 1-RM of bench press loadTimepoint: baseline to day 91 | — |
Secondary
| Measure | Time frame |
|---|---|
| Comparison of change between Ashwa SR 300 mg and placebo groups for following parameters: Muscle strength from baseline to day 30, and 60 in 1-RM of bench press load. VO2 max Serum testosterone levels Serum creatine kinase levels, Lactate dehydrogenase levels Comparison of global assessment of therapy Comparison of TEAEs. Comparison of General QOL- SF-12 Timepoint: baseline to day 91 | — |
Countries
India
Contacts
Public ContactT Vijaya Bhaskar
Invitro Research Solutions Pvt. Ltd.
Outcome results
None listed