None listed
Conditions
Interventions
Intervention1: Manasamitra Vatakam: Ayurvedic Herbomineral formulation,single dose of polyherbal formulation consisted of various plant extracts and minerals comprising the tablet weight id 182.5mg on
Sponsors
SRM Institute of Science and Technology
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
India
Contacts
Public ContactSrikalyani Vemuri
SRM Institute of Science and Technology
Outcome results
None listed