Comparative study of KSM-66 Ashwagandha (Withania somnifera) in Adults Experiencing High Stress and/or Anxiety

Completed

Brief Summary: This multi-centre study will compare the effects of Ashwagandha extract 600 mg/day with placebo for its effect on improvement of stress and anxiety in male and female adult individuals. The study will be conducted across 7-10 centers in India and 3-5 centres out of India.

Enrolled patients will receive one capsule of ashwagandha (300mg) or identical placebo capsule (starch 300 mg) two times daily with water for a period of 8 weeks.

Central randomization will be used for random allocation of tretament.

Efficacy outcomes are the Hamilton-Anxiety (HAM-A) scale and the Perceived Stress Scale (PSS) for anxiety and tress assessment respectively. Other efficacy outcomes will be the remission of symptoms of anxiety and stress.

Serum cortisol will be measured at baselne and 8 weeks as a measure of stress.

PSS will be assessed at baseline and then on 4 and 8 weeks. All other efficacy assessments shall be at baseline and 8 weeks.

Safety outcomes will be based on clinical safety assessed by the adverse events reported.

Clinical Global Impression (CGI) for efficacy and safety will be assessed at the end of 8 weeks

Recruitment & Eligibility

Inclusion Criteria

1.Adults (male and female) aged between 18 and 65 years 2.Experiencing signs and symptoms suggestive of high stress (e.g., difficulty concentrating, physical exhaustion, anxiety, restlessness, insomnia, headache, fatigue, loss of appetite, worry, sweating, mental confusion etc.) 3.Hamilton Anxiety Rating Scale (HAM-A) total score between 14 and 30 at the screening/randomization visit 4.Perceived Stress Scale (PSS) score â‰¥13 at the screening/randomization visit 5.BMI between 20 and 35 6.No plan to commence new treatments over the study period 7.Non-smoker 8.Medication-free (any medications known to affect stress and anxiety) for at least 4 weeks.
Use of analgesics (once a week) or contraceptive pill are permissible.
9.Must have the ability and willingness to sign an informed consent and to comply with all study procedures.

Exclusion Criteria

1.Patients receiving any of the medications known to affect stress and anxiety (corticosteroids, antidepressants, anti-psychotics, mood stabilizers, and anti-epileptic medications) during 4 weeks prior to screening.
2.Patients having total score less than 14 on HAM-A at screening.
3.Patients currently (or within the past 4 weeks prior to screening) taking any over the counter use of herbal extracts such as Ginkgo Biloba, St. Johnâ€™s Wort, Omega-3 etc.
4.Patients with depressive episode, suicidal tendency, panic disorder, social phobia, obsessive-compulsory disorder; alcohol dependency; schizophrenia and mania 5.Patients with known post-traumatic stress disorder (PTSD) 6.Patients who have an established practice of meditation and relaxation techniques for three or more months 7.Patients with known clinically significant acute unstable hepatic, renal, cardiovascular or respiratory disease that will prevent participation in the study 8.Patients with history of alcohol, tobacco dependence or with any substance abuse 9.Pregnant and lactating women or suspected to be pregnant 10.Patients with known hypersensitivity to Ashwagandha 11.Patients who had participated in other clinical trials during previous 3 months 12.Patients who have any clinical condition, according to the investigator which does not allow safe fulfillment of clinical trial protocol.

Primary Outcome Measures

Name	Time	Method
Mean change from baseline in Hamilton Anxiety Rating Scale (HAM-A) total score	8 weeks

Secondary Outcome Measures

Name	Time	Method
Remission in symptoms of anxiety and stress (Remission defined as a total HAM-A score of â‰¤7 at follow-up visits)	8 weeks
Mean change from baseline in Perceived Stress Scale (PSS) score total score	4 weeks and 8 weeks
Change from baseline in Item 2 (tension) of the (HAM-A)	8 weeks
Change from baseline in Item 1 (anxious mood) of the Hamilton Anxiety Rating Scale (HAM-A)	8 weeks
Change from baseline in serum Cortisol level	8 weeks

Locations (12): Bharati Vidyapeeth Medical College & Hospital
🇮🇳
Pune, MAHARASHTRA, India
BLDE (Deemed to be University)
🇮🇳
Bijapur, KARNATAKA, India
CLINI-TON Multispeciality Clinic
🇮🇳
Jaipur, RAJASTHAN, India
D Y Patil Medical College and Hospital
🇮🇳
Thane, MAHARASHTRA, India
Metabol
🇮🇳
(Suburban), MAHARASHTRA, India
MGM Medical College & Hospital
🇮🇳
Raigarh, MAHARASHTRA, India
Prajakta Clinic, Ghatkopar East
🇮🇳
Mumbai, MAHARASHTRA, India
Prakruti Care Hospital
🇮🇳
Thane, MAHARASHTRA, India
Prime Hospital
🇮🇳
Ahmadabad, GUJARAT, India
SGD Superspeciality Clinic
🇮🇳
Jaipur, RAJASTHAN, India
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Bharati Vidyapeeth Medical College & Hospital
🇮🇳Pune, MAHARASHTRA, India
Dr Priti Pravin Dhande
Principal investigator
9922426840
priti.dhande@bharatividyapeeth.edu