This study is to establish how Pine bark extract (Trademark: Pinorox) is effective and tolerable in normal and sports subjects
- Registration Number
- CTRI/2019/03/018174
- Lead Sponsor
- Ambe Phytoextract Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 50
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Change from Baseline in Rate of oxygen consumption VO2 max (Endurance) compared to placebo <br/ ><br>2. Assessment of anaerobic power and rate of fatigue by using wingate test. <br/ ><br>Timepoint: Baseline, Day 30, Day 60 an Day 90
- Secondary Outcome Measures
Name Time Method 1. Change in assessment values using 1-RM test <br/ ><br>2. Quality of life questionnaire assessment using SF-36 <br/ ><br>3. Laboratory tests: CBC, Serum creatinine, SGOT and. SGPTTimepoint: Baseline and Day 90