CTRI/2016/06/007017
Completed
未知
A randomized, pilot, double blind, placebo controlled cross-over human study to evaluate the efficacy of oxystorm on physical endurance in healthy volunteers
Arjuna Natural Extracts Ltd0 sites12 target enrollmentTBD
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Arjuna Natural Extracts Ltd
- Enrollment
- 12
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Subject has a B.W in between 45 to 75 kg.
- •2\. Subject is a non\-smoker.
- •3\. Subject is in good health and appropriate for exercise.
- •4\. Subject agrees to not use any new vitamins and/or minerals until after study completion and to not take any vitamins and/or minerals 24 hours prior to the test visits.
- •5\. Subject agrees to not use any dietary or herbal supplements until after study completion. A 7\-day washout is allowed for study inclusion.
- •6\. Subject is willing and able to comply with the protocol including:
- •Attending 4 visits each of which is approximately 3 hours long;
- •Refraining from caffeine, over\-the\-counter medications and alcohol for the 24 hours prior to the test visits;
- •Refraining from physical training or exercise for the 48 hours prior to the test visits;
- •Refraining from taking any dietary or herbal supplements throughout the study.
Exclusion Criteria
- •The subjects will be excluded based on the following criteria during screening and during the study.
- •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 reports being a regular caffeine consumer defined as consuming \> 600 mg of caffeine per day.
- •9\. Subject has a clinically relevant abnormality as defined by the PI or interpreting physician with respect to the physical examination.
Outcomes
Primary Outcomes
Not specified
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