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.

A multi-centric, double-blind, randomized controlled trial to assess safety and efficacy of a proprietary Ayurvedic medicine, “Tab. Prasham? in the management of anxiety disorders as an add-on treatment to the Standard of Care. - PRASHAM-Q1

Status

Recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/01/049009

Enrollment

Registered

2023-01-13

Start date

Unknown

Completion date

Unknown

Last updated

2023-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: F411- Generalized anxiety disorder

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
To assess improvement in the Hamilton Anxiety Rating Scale in Anxiety DisordersTimepoint: 2 Months	—

Secondary

Measure	Time frame
I.To assess improvement in sleep through Insomnia Severity Index (or Regensburg Insomnia Scale or Athens Insomnia Scale) II.To assess improvement in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q), III.To assess incidences of adverse events and treatment emergent adverse events during the treatment period Timepoint: 2 Months	—

Countries

India

Contacts

Public ContactDr Hrishikesh Rangnekar

Quest Clinical Services

dr.rangnekar@gmail.com9890901109

Outcome results