None listed
Conditions
Interventions
Intervention1: Ashwagandha
: Each capsule containing
Ashwagandha extract 300 mg
to be taken two capsules
daily orally in the morning
after breakfast and night after dinner: Duration 60 days
Contr
Sponsors
Ingex Botanicals Private Limited
Bio Actives Japan KK
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male volunteers between the age group of 25-45 years. 2. Subjects who are familiar with weight training and had at least 3 months of experience in the gym (defined as 4 times per week for minimum of 3 to 4 hours per week). 3. Subjects who are willing and able to understand and follow the protocol and provide informed consent. 4. Agree not to use any medication (prescription and over the counter), including vitamins and minerals, and any alternative medications during the course of this study. 5. Subjects whose blood chemistries are within a normal range or not considered clinically significant if outside the normal range
Exclusion criteria
Exclusion criteria: 1.Concomitant severe decompensated systemic disease (cardiovascular, renal, hepatic, endocrine, hematological, neurological, immunological) 2. Patients with pre-existing severe systemic disease necessitating long-term medication. 3. Subjects suffering from any serious medical or surgical illness. 4. History of cancer, including solid tumors, hematologic malignancies and carcinoma in situ. 5. Any neurological (congenital or acquired), musculoskeletal, joint health conditions, psychological, vascular or systemic disorder which could affect any of the efficacy assessments. 6. Significant abnormal findings as determined by baseline history, physical examination, vital signs (blood pressure, pulse rate, respiration rate), ECG hematology, serum chemistry. 7. More than 4 short courses of oral corticosteroids within the year preceding the screening visit, or any oral corticosteroids in the preceding 4 weeks. 8. Use of Astemizole, Nedocromil, Cromolyn, long acting beta agonists, Ketotifen, Theophylline or testosterone within 4 weeks before. 9. Participation in the current or previous clinical trial with any approved investigational products during the past 1 month.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Endpoints: 1.change from baseline muscle and connective tissue strength, assessed by one-repetition maximum (1-RM) bench and leg presses 2.Handgrip strength (Dynamometer) 3.Cable pull-down repetitions and pounds 4.Time to exhaustion on a treadmill 5.Mid-upper arm circumference (MUAC) 6.The change from baseline testosterone assessed by free and total testosterone. 7.Improvement in Muscle Strength, stamina and sustained energy level and the safety of Ashwagandha extract product and consumer acceptance through Self Assessment and Feedback questionnaires through Global Physical Activity QuestionnairesTimepoint: Day 0, Day 30 and Day 60 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.The improvement in Cortisol cycle from baseline is assessed by evaluating Cortisol value 2.Improvement in muscle recovery measured through Biomarkers LDH (Serum lactate de-hydrogenase), CK (Creatine Kinase), TNF alpha, Glutathione (GSH) & hs-CRP 3.Change in Serum Collagenase level 4.Change in Serum immune marker levelsTimepoint: Day 0 & Day 60. | — |
Countries
India
Contacts
Public ContactDr Ashok Godavarthi
Radiant Research Services Pvt Ltd
Outcome results
None listed