A Study to Evaluate the Safety, Efficacy and Tolerability of Clonazepam 0.25 mg and Clonazepam 0.25mg with Propranolol 10/20 mg in Patients With Anxiety disorders

A Randomized, Double-Blind, Multicentric, Active Controlled, Phase IV Clinical Study to Evaluate the Safety, Efficacy and Tolerability of Fixed Dose Combination of Clonazepam 0.25 mg and Propranolol 10/20 mg In Patients With Anxiety Disorders

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2017/12/010962

Enrollment

150

Registered

2017-12-22

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: null- Anxiety Disorders

Interventions

Intervention1: Arm 2: Subjects will be administered with fixed dose combination of Clonazepam 0.25 mg + Propranolol 10 mg tablet once daily for 8 weeks Intervention2: Arm 3: Subjects will be adminis

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients between 18- 65 years of age 2. Patients with established diagnosis of Anxiety (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition DSM V) 3. Total Hamilton Rating Scale for Anxiety (HAM-A) score >=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

Exclusion criteria

Exclusion criteria: 1. Pregnancy and/or lactation 2. Patients with a history of mania, schizophrenia, seizures, narrow angle glaucoma, pre-existing CNS depression or coma, respiratory depression, acute pulmonary insufficiency, hyper thyroidism, myasthenia gravis, diabetes mellitus, sleep apnoea, chronic pulmonary insufficiency and/or muscle weakness 3. Patients with suicidal tendencies 4. Patients operating hazardous machinery, including automobiles 5. Patients with renal and/or hepatic insufficiency 6. Patients who have a history of hypersensitivity to clonazepam and/or Propranolol and/or any components of the formulations 7. Patients with any other serious concurrent illness or malignancy 8. Patients with continuing history of alcohol and/or drug abuse 9. Participation in another clinical trial in the past 3 months.

Design outcomes

Primary

Measure	Time frame
Change in the score on the Hamilton Rating Scale for Anxiety (HAM-A) at the end of treatment(8th week) as compared to baselineTimepoint: Baseline to week 8	—

Secondary

Measure	Time frame
Degree of improvement in the mean CGI-S (global severity of the CGI scale) score at the end of study (8th week) as compared to baseline.Timepoint: Baseline to week 8;Percentage of patients having a 50% reduction in the HAM-A total score at the end of the study (8th week) as compared to baseline Timepoint: Baseline to week 8	—

Countries

India

Contacts

Public ContactDr Krishna Kumar M

Micro Labs Limited

drmanjula@microlabs.in08022370451

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026