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The present study is a placebo- controlled, single-blind sequential study. Total of 40 males aged between ≥ 18 years and ≤35 years will be screened. Assuming screen failure and dropout rate in this study, a minimum of 30 participants should complete the study. The treatment duration for all the study participants will be 60 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EB-PA | Active Comparator | One capsule to be taken after breakfast once a day for 30 days |
|
| Placebo | Placebo Comparator | One capsule to be taken after breakfast once a day for 30 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EB-PA | Dietary Supplement | 1 capsule to be taken after breakfast once a day |
| |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the effect of 30 days (Baseline to end of treatment period) administration of investigational product (IP) from baseline on | Improvement in muscle strength as assessed by isokinetic peak torque (measured during knee extension and flexion) | Day 31 |
| To assess the effect of 30 days (Baseline to end of treatment period) administration of investigational product (IP) from baseline on | Improvement in muscle strength as assessed by isokinetic peak torque (measured during knee extension and flexion) | Day 61 |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the effect of 30 days (Baseline to end of treatment period) administration of investigational product (IP) on | Increase in the lower-body strength (Peak anaerobic power output (PAPw)) as assessed by a vertical jump test | Day 0, Day 31 and Day 61 |
| To assess the effect of 30 days (Baseline to end of treatment period) administration of investigational product (IP) on |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dr. Shalini Srivastava, MBBS, MD | Contact | 02242172300 | shalini.s@vediclifesciences.com | |
| Dr. Sonali Ghosh, BAMS | Contact | 02242172300 | sonali.g@vediclifesciences.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr. Kumta Solanki's Clinic | Not yet recruiting | Mumbai | Maharashtra | 400053 | India |
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Single-blind, placebo - controlled trial
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| Placebo |
| Dietary Supplement |
1 capsule to be taken after breakfast once a day |
|
Improvement in upper body strength as assessed by medicine ball throw test |
| Day 0, Day 31 and Day 61 |
| To assess the effect of 30 days (Baseline to end of treatment period) administration of investigational product (IP) on | The flexibility of the hamstrings as assessed using the V sit-and-reach test | Day 0, Day 31 and Day 61 |
| To assess the effect of 30 days (Baseline to end of treatment period) administration of investigational product (IP) on | Improvement in muscle mass as indicated by an increase in fat-free mass (FFM) by DXA | Day 0, Day 31 and Day 61 |
| To assess the effect of 30 days (Baseline to end of treatment period) administration of investigational product (IP) on | Decrease in central obesity as indicated by a decrease in android fat percentage by DXA. | Day 0, Day 31 and Day 61 |
| To assess the effect of 30 days (Baseline to end of treatment period) administration of investigational product (IP) on | Improvement in metabolic health as indicated by the waist-to-height ratio (WHtR) | Day 0, Day 31 and Day 61 |
| To assess the effect of 30 days (Baseline to end of treatment period) administration of investigational product (IP) on | Improves muscle protein synthesis as assessed by an increase in serum insulin at 0, 1 & 3 hours post IP administration. | Day 0, Day 31 and Day 61 |
| Dr. Preeti Bawaskar's Clinic | Recruiting | Thane | Maharashtra | 400607 | India |
|