This study will be conducted in healthy adults with stress and anxiety, the effect as well as safety of Ashwagandha will be assessed in improving their quality of life.
- Registration Number
- CTRI/2020/02/023321
- Lead Sponsor
- Sami Labs Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
1 Male and female healthy adults 21 to 54 years old.
2 Body Mass Index (BMI) in the range of 18 to 32 kg/m2.
3 Subjects free of any psychological or psychiatric conditions except stress & anxiety.
4 Adults with perceived stress scale score less than 25 and more than 14.
5 Adults complaining with anxiety,fatigue,loss of appetite,Insomnia and loss of concentration.
6 Subject must be willing and able to adhere to the assessments,visit schedules,
prohibitions and restrictions,as described in this protocol.
7 Willing to sign informed consent.
1 Pregnant and lactating female or female having the intention to be pregnant within next
three months.
2 Education level below 8th grade of schooling.
3 Unable to read or understand English or having no working knowledge of English.
4 History of alcohol abuse, excessive smoking with more than 5 cigarettes a day.
5 Established/ diagnosed neurological or psychiatric disorders.
6 With chronic gastrointestinal diseases, severe immune deficiency.
7 Lipid profile, haematological parameters, Glycaemic parameters above normal limits.
8 History of intake of ANY Ayurvedic/herbal/homeopathic/ dietary supplements
(including Vitamin E) or any alternative therapies in the last one month.
9 History of bone marrow disorders.
10 Acute medical/surgical complications which require hospitalization.
11 Subjects with history of clinically significant thyroid disorder (hypo or hyper),
cardiovascular, haematological,hepatic (SGOT or SGPT levels >2 Upper Limit of
Normal),renal (serum creatinine>=1.3 mg/dl), respiratory,or genitourinary
abnormalities or diseases.
12 A history of significant multiple and/or severe allergies or anaphylactic reactions.
13 Subjects with known history of hypersensitivity to the investigational product.
14. Subject has participated in any clinical trial within last 3 months.
15. Any other condition which the Principal Investigator thinks may jeopardize the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method