None listed
Conditions
Interventions
Intervention1: Withania somnifera 250 mg capsule: Oral total of 3 doses 12 hours apart.
Intervention2: Withania somnifera 500 mg capsule: Oral total of 3 doses 12 hours apart.
Control Intervention1: I
Sponsors
Dr C Gayatri Devi
Eligibility
Inclusion criteria
Inclusion criteria: A total of 12 healthy male volunteers aged between 18-45 years, body mass index (BMI) within 10% of the ideal body weight and not less than 50 kg body weight were included in the study. All the included volunteers had normal cardiac, hepatic and renal functions, and a written informed consent was obtained from all of them. Abstinence from smoking and alcohol consumption in the last 48 hours is ensured before the start of study procedure
Exclusion criteria
Exclusion criteria: Volunteers with a known history of hypersensitivity to sulfa drugs, those who were taking any other medication which will affect GI motility (macrolide antibiotics, prokinetics etc.) two weeks prior to the study, those who had history of gastrointestinal disorders (diarrhoea, constipation) or abdominal surgery and subjects with history of allergy, asthma or porphyria were excluded from the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The predefined primary efficacy end point was a decrease in the OCTT with Withania somnifera 500 mg and 250 mg as compared to placeboTimepoint: Salivary sample will be collected at baseline and at every 15 minutes interval from 2 to 8 hours | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary safety endpoints will be incidence of adverse events and patient compliance to the test formulation.Timepoint: at the end of the study | — |
Countries
India
Contacts
Public ContactC Gayatri Devi
Nizams Institute of medical sciences
Outcome results
None listed