None listed
Conditions
Interventions
Intervention1: Polyherbal Diabetes formulation: Single oral administration of Polyherbal formulation of S.oblonga, S.roxburghii, L.parviflora and G.indica plant extracts.
Each unit dose is made up of
Sponsors
SRM University
Department of Science and Technology
Eligibility
Inclusion criteria
Inclusion criteria: Healthy male volunteers of 18 to 45 yrs (both years inclusive) and body weight > 50 kg. Willing to give informed written consent and comply with the study requirements. Subject should be able to communicate effectively. Non-smokers or individuals who smoke less than 5 cigarettes per day Teetotalers or individuals who drink less than 60 ml of high-alcohol-content liquor or 120 ml of low-alcohol-content liquor Body Mass Index (BMI) between 18.50 and 24.99 Kg/m2 Healthy individuals as evaluated by personal history,medical history and general clinical examination. Vital parameters - BP should be within the range of 100 â?? 139 mmHg systolic and 60 â?? 89 mmHg diastolic. Pulse rate should be within the range of 60 â?? 100 / min. Oral temperature between 97.8Ë? F and 99.0 Ë? F. Respiratory rate should be within the range of 14-18/min. Normal biochemical, hematological and urinary parameters. Normal Chest X - ray PA view & ECG in 12 leads. Negative for HIV 1 & 2, Hepatitis B, Hepatitis C and Syphilis tests. Negative urine test for drugs of abuse for morphine, barbiturates,benzodiazepines, amphetamine, THC & cocaine (to be performed on the day of check in). Negative alcohol breath analysis (to be performed on the day of check in).
Exclusion criteria
Exclusion criteria: Subjects incapable of understanding the informed consent. History of any major surgical procedure in the past 3 months. History of diabetes mellitus, tuberculosis and systemic hypertension. History suggestive of cardiac, gastrointestinal, respiratory, hepatic, renal, endocrine, neurological, metabolic, psychiatric or hematological systems, judged to be clinically significant. History of dysphagia. History of any medical disorder that is of significance in the investigatorâ??s opinion. Present or past history of drug abuse. History of hypersensitivity to study formulation. History of allergy to vegetables and / or food substances and / or any other manifestations suggestive of hypersensitivity reactions.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax, Tmax, AUC0-t, AUC0-inf , Kel rate of elimination and half life T1/2, Clearance will be reported Timepoint: 01.00, 02.00, 03.00, 03.30, 04.00, 04.30, 05.50, 06.50, 08.00, 10.00,16.00 and 24.00 hours post dose (Total of 12 samples - 5 mL each) | — |
Secondary
| Measure | Time frame |
|---|---|
| ADVERSE DRUG REACTIONS (SAFETY OF DRUG)Timepoint: Through out the pharmacokinetic study and post 6 days | — |
Countries
India
Contacts
Public ContactDr K Ilango
SRM University
Outcome results
None listed