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.

Recruiting

• Conditions: With chronic fatigue, stress and anxiety

• Registration Number: CTRI/2020/02/023321
• Lead Sponsor: Sami Labs Limited

Brief Summary

The purpose of this study is to assess the efficacy and safety of Ashwagandha in adults with chronic fatigue, stress and anxiety.

After obtaining informed consent in the language best understood by the patient, they will be screened as per the inclusion criteria and those fulfilling the criteria will be enrolled in the study. Subject’s would be randomized into two groups, one group will receive Shagandha 500 mg once a day before bedtime for 60 days, while the other group will receive Placebo  500 mg once a day before bedtime for 60 days.

The primary endpoints would be change in CABTAB score, PSS Score and Quality of Life from Baseline to Final visit. The secondary endpoints would be change in Generalized anxiety disorder - 7 item scale, Salivary cortisol, Urine Serotonin and dopamine, antioxidant stress markers and laboratory parameters. Adverse events would be assessed throughout the study.

Appropriate statistical analysis would be applied to the data outcomes and discussion and conclusion will be made accordingly.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-02-18
• Last Update Posted: 2021-02-24

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

• 1 Male and female healthy adults 21 to 54 years old.
• 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.

Exclusion Criteria

• 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.
• Subject has participated in any clinical trial within last 3 months.
• 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
1 Change in CANTAB score	1 CANTAB score(Day0 & Day60) | 2 PSS scale(Screening,Day30 & Day60) | 3 WHOQOL-BREF(Day0 & Day60)
2 Change in PSS scale	1 CANTAB score(Day0 & Day60) | 2 PSS scale(Screening,Day30 & Day60) | 3 WHOQOL-BREF(Day0 & Day60)
3 Change in WHOQOL-BREF	1 CANTAB score(Day0 & Day60) | 2 PSS scale(Screening,Day30 & Day60) | 3 WHOQOL-BREF(Day0 & Day60)

Secondary Outcome Measures

Name	Time	Method
1 Change in Generalized Anxiety Disorder - 7 item scale.	2 Change in Salivary cortisol.

Trial Locations

Locations (2)

Narayana Health; 🇮🇳 Bangalore, KARNATAKA, India

Vijaya Super Speciality Hospital; 🇮🇳 Nellore, ANDHRA PRADESH, India

Narayana Health

🇮🇳Bangalore, KARNATAKA, India

Dr Vikneswaran G

Principal investigator

09787649182

vikneswaran.g.dr@narayanahealth.org