None listed
Conditions
Interventions
Intervention1: Not Applicable: Not Applicable
Control Intervention1: Zenroot Ashwagandha 8% (50 mg providing 4 mg total
withanolides): Zenroot Ashwagandha Capsules
Oral Dose
4 times (each period once)
Sponsors
Dr Arun Balakrishnan Mr Abhijeet Ashok Morde
Eligibility
Inclusion criteria
Inclusion criteria: Normal, healthy, adult, human subjects (12 Males and 8 Females) of age between 18-55 years (both inclusive) and Body Mass Index (BMI) ranges between 20.00 kg/m2 to 29.99 kg/m2 Subjects who have no evidence of underlying disease during screening and check-in and whose screening is performed within 21 days of check in Subjects whose screening laboratory values are within normal limits or considered by the physician or principal/clinical investigator to be of no clinical significance Healthy as documented by the medical history, physical examination (including but may not be limited to an evaluation of the cardiovascular, gastrointestinal, respiratory, musculoskeletal and central nervous system) and vital sign assessments Generally healthy as documented by 12-lead electrocardiogram (ECG), Chest X-Ray and clinical laboratory assessments
Exclusion criteria
Exclusion criteria: Evidence of allergy or known hypersensitivity to Ashwagandha or its metabolites Subjects with hepatic encephalopathy cholestasis myasthenia pre-existing liver disease alcohol abuse existing tinnitus and pre-existing gallbladder disease Any major illness in the last three months or any significant ongoing chronic medical illness Renal or liver impairment Any disease or condition which might compromise the haemopoeitic, gastrointestinal, renal, hepatic, cardiovascular, musculoskeletal, respiratory, central nervous system, or any other body system, presence of diabetes mellitus and psychosis History of alcohol addiction or abuse Consumption of caffeine and /or Xanthine containing products
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the bioavailability of total withanolides from a single oral dose of Product A - Zenroot Ashwagandha 8%, Product B - Zenroot Ashwagandha 1.5%, Product C - KSM-66 shwagandha 5 and Product D - Sensoril Ashwagandha 10% in healthy adult human subjects under fasting conditionsTimepoint: 13 time points 0.00 Hrs 00.25 Hrs 00.50 Hrs 00.75 Hrs 01.00 Hrs 02.00 Hrs 03.00 Hrs 04.00 Hrs 05.00 Hrs 06.00 Hrs 09.00 Hrs 12.00 Hrs and 24.00 Hrs | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare the bioavailability of Withanoside IV, Withanolide A, 12 deoxywithanstramonolide and Withaferin A from a single oral dose of Product A - Zenroot Ashwagandha 8%, Product B - Zenroot Ashwagandha 1.5%, Product C - KSM-66 Ashwagandha 5% and Product D - Sensoril Ashwagandha 10% in healthy adult human subjects under fasting conditionsTimepoint: 13 time points 0.00 Hrs 00.25 Hrs 00.50 Hrs 00.75 Hrs 01.00 Hrs 02.00 Hrs 03.00 Hrs 04.00 Hrs 05.00 Hrs 06.00 Hrs 09.00 Hrs 12.00 Hrs and 24.00 Hrs | — |
Countries
India
Contacts
Public ContactDr Annamalai K MBBS MBA MSc
Spinos Lifescience and Research Private Limited
Outcome results
None listed