None listed
Conditions
Interventions
Intervention1: Each capsule contains 200 mg Pine bark extract (Pinorox TM): Once daily after meal or in between the meals for 90 days. Should not take on empty stomach.
Control Intervention1: Placebo
Sponsors
Ambe Phytoextract Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age: 18-40 years and BMI between 18.0 â?? 24.9 kg/m2 2. Mentally, physically and legally eligible to give informed consent. 3. Male and female healthy sedentary subjects (Daily routine with no or little exercises) and sports subjects (Average in more than 3 sessions per week) 4. Patient is willing and able to comply with all trial requirements 5. Subjects who have not participated in a similar investigation in the past three months. 6. Subject is in good health and appropriate for exercise. 7. Subject agrees to not use any dietary or herbal supplements and maintain their normal dietary intake until after study completion. 8. Subject agree to avoid the intake of anti-oxidant rich food. 9. Subjects will be required to refrain from exercise 48 hours prior to the experiment and to fast two hours before. 10. Subject should have normal hematology and Biochemistry ranges.
Exclusion criteria
Exclusion criteria: 1. Subjects with or prior history or presence of clinically significant Cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, musculoskeletal, neurological or psychiatric disease. 2. Subject has any orthopedic problem(s) or history of musculoskeletal injury(ies) which make(s) resistance weight training contraindicated. 3. Subject has a history of cancer (except localized skin cancer without metastases) within 5 years prior to screening. 4. No prescription or chronic medication use allowed without PI discretion. 5. Subject has an allergy to any of the ingredients in the test product. 6. Subject is currently taking and unwilling to refrain from taking any over-the-counter stimulant medications/ supplements; seven-day washout required for study inclusion. 7. Subject is currently taking and unwilling to refrain from taking any over-the-counter allergy or asthma medication containing pseudoephedrine or ephedrine; seven-day washout required for study inclusion. 8. Subject has a clinically relevant abnormality as defined by the PI or interpreting physician with respect to the physical examination. 9. Subject has a history of drug or alcohol abuse in the past 12 months. 10. Subject has any condition or abnormality that, in the opinion of the investigator, would compromise the safety of the subject or the quality of the study data.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Change from Baseline in Rate of oxygen consumption VO2 max (Endurance) compared to placebo 2. Assessment of anaerobic power and rate of fatigue by using wingate test. Timepoint: Baseline, Day 30, Day 60 an Day 90 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change in assessment values using 1-RM test 2. Quality of life questionnaire assessment using SF-36 3. Laboratory tests: CBC, Serum creatinine, SGOT and. SGPTTimepoint: Baseline and Day 90 | — |
Countries
India
Contacts
Public ContactAnjali Rawat
Pharexcel Consulting
Outcome results
None listed