Bio availability study of Berberine in Manasamitra Vatakam: An ayurvedic herbomineral formulatio
- Registration Number
- CTRI/2020/02/023267
- Lead Sponsor
- SRM Institute of Science and Technology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Willingness to provide written informed consent to participate in the study.
Volunteers understanding the nature and purpose of the study and who are willing to comply with study procedures.
Non-smokers or individuals who smoke less than 5 cigarettes per day.
Teetotalers.Healthy individuals as evaluated by personal history, medical history and general clinical examination
History suggestive of cardiac, gastrointestinal, respiratory, hepatic, renal, endocrine, neurological, metabolic, psychiatric or hematological systems, judged to be clinically significant.
Subject with clinically significant abnormal values of laboratory parameters.History of diabetes mellitus, tuberculosis and systemic hypertension.
Subject who had participated in any other clinical study during the last 3 months.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The information regarding the ADME parameters of berberine in the investigation product i.e., Manasamitra Vatakam have not been investigated and hence the present study involves in determine the pharmacokinetic parameters from the healthy human male volunteers.Timepoint: 0min, 30min, 60min, 90min, 2H, 4H, 6H, 8H, 10H, 12H , 24H
- Secondary Outcome Measures
Name Time Method The relation between the plasma concentration and the therapeutic effects are studied to employ the safety and efficacy of the formulation.Timepoint: 0min, 30min, 60min, 90min, 2H, 4H, 6H, 8H, 10H, 12H , 24H