None listed
Conditions
Interventions
Intervention1: Sabeet®: One sachet daily with 150 ml of water for 2 weeks.
Control Intervention1: Placebo: One sachet daily with 150 ml of water for a period of 2 weeks.
Sponsors
Sami labs Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1 Male healthy adult subjects ranging in age from 18 to 55 years (both inclusive) normotensive, physically active but not exercise trained. 2 Willingness to follow the protocol requirements as evidenced by written, informed consent. 3 Agree not to use any medication (prescription and over the counter), including vitamins and minerals, during or before the course of this study. 4 Subjects whose blood chemistries are within a normal range or not considered clinically significant if outside the normal range. 5 Non-smokers and non-alcoholics. 6 Willing to come for all follow-up visits.
Exclusion criteria
Exclusion criteria: 1 Any clinically significant medical history, medical finding or an ongoing medical or psychiatric condition exists which in the opinion of the Investigator could jeopardize the safety of the subject, impact validity of the study results or interfere with the completion of study according to the protocol. 2 Significant abnormal findings as determined by baseline history, physical examination, vital signs (blood pressure, pulse rate, respiration rate, temperature) haematology, serum chemistry. 3 History of hypersensitivity reactions. 4 Participation in a clinical study during the preceding 90 days. 5 Any contraindication to blood sampling. 6 Blood or blood products donated in past 30 days prior to study supplement administration.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1 Standing blood pressure 2 Heart rate 3 Stroke volume and cardiac output 4 VO2 max by Cooper test 5 Time to exhaustion (cycling) 6 12-lead electrocardiogram 7 Gas exchange analysisTimepoint: 1 Standing blood pressure(Visit 2,Visit 3,Visit 4 & Visit 5) 2 Heart rate(Visit 2,Visit 3,Visit 4 & Visit 5) 3 Stroke volume and cardiac output(Visit 2,Visit 3,Visit 4 & Visit 5) 4 VO2 max by Cooper test(Visit 2,Visit 3,Visit 4 & Visit 5) 5 Time to exhaustion (cycling)(Visit 2,Visit 3,Visit 4 & Visit 5) 6 12-lead electrocardiogram(Visit 1,Visit 2,Visit 3,Visit 4 & Visit 5) 7 Gas exchange analysis(Visit 2,Visit 3,Visit 4 & Visit 5) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1 ESR and Hs-CRP 2 Plasma nitric oxide (NO)levels 3 Lactate dehydrogenase 4 Haematology, kidney and liver function testsTimepoint: 1 ESR and Hs-CRP (Visit 2,Visit 3,Visit 4 & Visit 5) 2 Plasma nitric oxide (NO)levels(Visit 2,Visit 3,Visit 4 & Visit 5) 3 Lactate dehydrogenase(Visit 2,Visit 3,Visit 4 & Visit 5) 4 Haematology, kidney and liver function tests(Visit 2,Visit 3,Visit 4 & Visit 5) | — |
Countries
India
Contacts
Public ContactDr Deepa Subramanian
ClinWorld Private Limited
Outcome results
None listed