A study to check safety and efficacy of an Ayurvedic medicine Tab. Prasham? in the management of Anxiety Disorders as an add-on therapy to the Standard of Care.
- Conditions
- Health Condition 1: F411- Generalized anxiety disorder
- Registration Number
- CTRI/2023/01/049009
- Lead Sponsor
- Ayurveda Rasashala
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
II.Patients fulfilling the diagnostic criteria for any of the Anxiety Disorders as per DSM 5
III.Voluntarily participation in the clinical trial and agreeing to follow study procedures
IV.Not participating in any other interventional drug clinical studies before completion of the present study
I.Inability to intake or tolerate oral medications
II.Known pregnant or lactating women
III.Patients with current or has a history of substance use disorder
IV.Patients having severe renal and hepatic impairment
V.Patients who displayed marked suicidal intent or known suicidal tendencies
VI.Where, in the opinion of the investigator, participation in this study will not be in the best interest of the subject, or any other circumstances that prevent the subject from participating in the study safely.
VII.Known allergies to components of the IP
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess improvement in the Hamilton Anxiety Rating Scale in Anxiety DisordersTimepoint: 2 Months
- Secondary Outcome Measures
Name Time Method I.To assess improvement in sleep through Insomnia Severity Index (or Regensburg Insomnia Scale or Athens Insomnia Scale) <br/ ><br>II.To assess improvement in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q), <br/ ><br>III.To assess incidences of adverse events and treatment emergent adverse events during the treatment period <br/ ><br>Timepoint: 2 Months