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A Clinical Study to assess the Safety and Effectiveness of a Fixed Dose Combination of Propranolol 20/40mg and Etizolam 0.5mg/0.5mg tablets in Patients with Anxiety Disorders.

An Open-Label, Multicentre, Comparative, Active-Controlled, Phase IV Clinical Study to Evaluate the Safety and Efficacy of Fixed-Dose Combination of Propranolol 20/40mg and Etizolam 0.5mg/0.5mg Tablets in Subjects with Anxiety Disorders. - Nil

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/05/110810
Enrollment
207
Registered
2026-05-21
Start date
Unknown
Completion date
Unknown
Last updated
2026-09-14

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

Intervention1: Fixed-Dose Combination of Propranolol Hydrochloride 20mg and Etizolam 0.5mg Tablet.: One Tablet to be taken orally twice daily for 56 days (8 weeks). Intervention2: Fixed-Dose Combinati

Sponsors

Windlas Biotech Limited
Lead Sponsor
Windlas Biotech Limited
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: Subject will be included if all the inclusion criteria listed below are met: 1. Subjects between 18- 65 years of age 2. Subjects with established diagnosis of Anxiety (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition DSM-5) 3. Total Hamilton Rating Scale for Anxiety (HAM-A) score more than or equal to 17. 4. CGI-S score greater than 4 in the week prior to inclusion of the study. 5. Willingness and able to give informed consent and comply with requirements for participation in the study Weeks before screening

Exclusion criteria

Exclusion criteria: Subject will be excluded if any exclusion criteria listed below are met: 1. Pregnancy and/or lactation. 2. Subjects with a history of mania, schizophrenia, seizures, narrow angle glaucoma, preexisting CNS depression or coma, respiratory depression, acute pulmonary insufficiency,hyperthyroidism, myasthenia gravis, diabetes mellitus, sleep apnoea, chronic pulmonary insufficiency and/or muscle weakness. 3. Subjects with suicidal tendencies. 4. Subjects operating hazardous machinery, including automobiles. 5. Subjects with renal and/or hepatic insufficiency. 6. Subjects who have a history of hypersensitivity to Etizolam and/or Propranolol and/or any components of the formulations. 7. Subjects with any other serious concurrent illness or malignancy. 8. Subjects with continuing history of alcohol and/or drug abuse. 9. Participation in another clinical trial in the past 3 months.

Design outcomes

Primary

MeasureTime frame
Incidence of TEAEs and SAEs evaluated on the basis of changes in clinical signs and symptoms . Timepoint: 8 weeks—

Secondary

MeasureTime frame
Change in the score on the Hamilton Rating Scale for Anxiety (HAM-A)Timepoint: 8 weeks;Percentage of subjects having a 50% reduction in the HAM-A total scoreTimepoint: 4 weeks;Degree of improvement in the mean Clinical Global Impressions-Severity Scale (CGI-S) scoreTimepoint: 4 and 8 weeks;Incidence of palpitationsTimepoint: 4 and 8 weeks;Incidence of panic attackTimepoint: 4 and 8 weeks;Improvement in Mental Health Quality of Life Questionnaire (MHQoL)Timepoint: 4 and 8 weeks;Proportion of subjects requiring withdrawal from the study due to AEs.Timepoint: 8 weeks;Changes in safety laboratory valuesTimepoint: 8 weeks—

Countries

India

Contacts

Public ContactMr Kartik Sahni

Insignia Clinical Services Pvt Ltd

kartik.sahni@insigniacs.com9868679414

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Sep 19, 2026