Health Condition 1: F40-F48- Anxiety, dissociative, stress-related, somatoform and other nonpsychotic mental disorders
Conditions
Interventions
Intervention1: Capsule containing Ashwagandha proprietary blend (300mg): Capsule containing Ashwagandha proprietary blend (300mg) to be taken twice a day for 8 weeks.
Intervention2: Capsule containing
Sponsors
Agaja Pharma Pvt. Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adults (male and female) aged between 18 and 65 years. 2.Experiencing signs and symptoms suggestive of 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 =13 at the screening/randomization visit. 5.BMI between 20 and 35. 6.No plan to commence new treatments over the study period. 7.Medication-free (any medications are known to affect stress and anxiety) for at least 4 weeks. Use of analgesics (once a week) or contraceptive pills are permissible. 8.Must have the ability and willingness to sign an informed consent and to comply with all study procedures.
Exclusion criteria
Exclusion criteria: 1.Patients receiving any of the medications known to affect stress and anxiety (corticosteroids, antidepressants, antipsychotics, mood stabilizers, and anti-epileptic medications) during 4 weeks prior to screening. 2.Patients having a total score of 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. John’s Wort, Omega-3, etc. 4.Patients with a 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) and Generalized Anxiety Disorder (GAD). 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 a history of alcohol, tobacco dependence, or any substance abuse.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Mean change in Hamilton Anxiety Rating Scale (HAM-A) questionnaire scores from baseline.Timepoint: Baseline, Week 4, Week 8;Mean change in liver (serum alanine transaminase, aspartate transaminase, alkaline phosphatase, bilirubin) parameters from baselineTimepoint: Baseline, Week 8;Mean change in Oxford Happiness Questionnaire scores from baseline.Timepoint: Baseline, Week 4, Week 8;Mean change in Profile of Mood States (POMS, abbreviated version) questionnaire scores from baseline.Timepoint: Baseline, Week 4, Week 8;Mean change in renal (serum creatinine, blood urea nitrogen) parameters from baselineTimepoint: Baseline, Week 8;Mean change in scores for Perceived Stress Scale (PSS) questionnaire from baseline.Timepoint: Baseline, Week 4, Week 8;Number & proportion of Treatment-Emergent Adverse Events (TEAEs) over 8 weeksTimepoint: Baseline, Week 8;Number & proportion of Treatment-Emergent Serious Adverse Events (TESAE) over 8 weeksTimepoint: Baseline, Week 8 | — |
Primary
| Measure | Time frame |
|---|---|
| Mean change in serum cortisol level from baselineTimepoint: Baseline, Week 8 | — |
Countries
India, United States of America
Contacts
Public ContactDr Anima Biswas
CLINI-TON- MULTI-SPECIALITY CLINIC
Outcome results
None listed