None listed
Conditions
Interventions
None listed
Sponsors
Sreejith Sreekumar
Eligibility
Inclusion criteria
Inclusion criteria: 1. Ambulatory, male or female, 18-45 years of age 2. Overall healthy, having no difficulty with digestion or absorption of food 3. Sneha Yogya 4. Willing and able to give written informed consent 5. Having no clinically significant abnormalities on the basis of medical history, physical examination and vital signs. 6. All values for hematology and clinical chemistry tests of blood within the normal range for age and gender or showing no clinically relevant deviations
Exclusion criteria
Exclusion criteria: 1. Having any medical condition(s) including diabetes, cardiovascular disease, pulmonary, renal, endocrine, hepatic, neurologic, psychiatric, immunologic, hematologic, gastrointestinal or metabolic disease requiring medical treatment that would preclude participation 2. Having had a history of any medical or surgical procedure that would preclude participation 3. Being pregnant, planning on becoming pregnant, breast feeding or unwilling to use a medically acceptable form of birth control during the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax (Peak Plasma Concentration): Identify the highest observed concentration of the active ingredient(s) in plasma.Timepoint: 0.5 hr, 1 hr, 2 hr, 4 hr, 8 hr, 12 hr,24 Hrs, Day 2,Day 3 up to day 7 or till Samyak Snigdha | — |
Secondary
| Measure | Time frame |
|---|---|
| Tmax (Time to Peak Plasma Concentration): Determine the time at which Cmax occurs.Timepoint: 0.5 hr, 1 hr, 2 hr, 4 hr, 8 hr, 12 hr,24 Hrs, Day 2,Day 3 up to day 7 or till Samyak Snigdha;AUC(0-t) (Area Under the Curve from 0 to the Last Measurable Time Point): Calculate the area under the concentration-time curve using trapezoidal or other appropriate methods.Timepoint: 0.5 hr, 1 hr, 2 hr, 4 hr, 8 hr, 12 hr,24 Hrs, Day 2,Day 3 up to day 7 or till Samyak Snigdha;t( ) (Half-life)Timepoint: 0.5 hr, 1 hr, 2 hr, 4 hr, 8 hr, 12 hr,24 Hrs, Day 2,Day 3 up to day 7 or till Samyak Snigdha;Complete Blood CountTimepoint: Pre Study,Day 1,Day 3-7,Day 30;Liver Function TestsTimepoint: Pre Study,Day 1,Day 3-7,Day 30;Lipid ProfileTimepoint: Pre Study,Day 1,Day 3-7,Day 30;Renal Function TestsTimepoint: Pre Study,Day 1,Day 3-7,Day 30;Heena,Ati and Mithya YogasTimepoint: 3 to 7 days;Adverse enentsTimepoint: Base line to End of Study | — |
Countries
India
Contacts
Public ContactSreejith Sreekumar
Glocal College of Ayurvedic Medical Sciences and Research Centre
Outcome results
None listed