Evaluation of effect of withania somniferas (Ashwagandha) on stress induced cardiovascular changes in healthy human subjects
- Registration Number
- CTRI/2013/05/003651
- Lead Sponsor
- Indian Council of Medical Research
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 24
1.Participants of either gender between 18-45 years of age and BMI of 18.5 to < 25 kg/m2.
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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Safety and Tolerability of Withania somnifera extract capsulesTimepoint: Baseline (Day 01) and Post Treatment(Day 15)