None listed
Conditions
Interventions
Intervention1: Withania somnifera capsule: Dose : 250 mg Capsule
Route of Administration : Oral
Treatment duration : 14 days
Subjects were asked to take 2 capsules BD with 240ml of drinking water dai
Sponsors
Indian Council of Medical Research
Eligibility
Inclusion criteria
Inclusion criteria: 1.Participants of either gender between 18-45 years of age and BMI of 18.5 to 2.Participants willing to sign informed consent 3.Participants with normal healthy conditions- Normal vitals, Physical examination, Normal weight and height as per LIC chart
Exclusion criteria
Exclusion criteria: 1.H/o of drug dependence or any severe co-morbid medical conditions. 2.H/o of serious adverse reactions or hypersensitivity to any drug. 3.Donation or loss of greater than 400 ml of blood in the period 0 to 12 weeks before entry to the study. 4.Abnormality in routine lab investigations like complete blood picture, complete urine examination, liver function tests or renal function tests. 5.Participating in any drug trials/ research projects over the past 3 months. 6.Alcohol consumption 24 hrs before study day. 7.Tea/Coffee consumption or smoking 12 hrs before the study day. 8.Pregnant/breast feeding/ child bearing potential participants.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean percentage change in hemodynamic properties and arterial wave reflections on treatment with withania somnifera extract compared to placeboTimepoint: Baseline (Day 01) and Post Treatment(Day 15) | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety and Tolerability of Withania somnifera extract capsulesTimepoint: Baseline (Day 01) and Post Treatment(Day 15) | — |
Countries
India
Contacts
Public ContactDr Usharani
Nizams Institute of Medical Sciences,
Outcome results
None listed