Prescriber Based, Active Post Marketing Surveillance Study (PMS) to Generate The Safety & Efficacy Data Of Diazepam and Propranolol in The Treatment of Chronic Anxiety & Insomnia in Actual Field Conditions Of Use.
- Conditions
- Health Condition 1: F411- Generalized anxiety disorder
- Registration Number
- CTRI/2020/03/023789
- Lead Sponsor
- AN Pharmacia Laboratories Pvt ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 200
1. Both Male and Female patient.
2. Ages: > 18 years and < 65 years.
3. Patients with Chronic Anxiety and Insomnia.
4. Confirmed diagnosis of primary insomnia (as defined by
the Diagnostic and Statistical Manual for Mental
Disorders-IV [DSM-IV-TR]) present at the time of
evaluation for at least 3 months
5. Baseline Hamilton Rating Scale for Anxiety (HAMA)
scores >=18
6. Patient with history of primary insomnia
7. Women of child bearing age willing to take contraceptive
measure to prevent pregnancy during the study
8. Patients willing to give written informed consent
1. History of hypersensitivity to the study drugs
2. Chronic heart failure, respiratory failure or chronic liver and renal failure.
3. Patient with active cancer
4. Female who is pregnant, planning a pregnancy (during the course of the study) or nursing a child
5. Certain medications that may interfere with the study medication and worsen the patient condition (these will be identified by the study Investigator).
6. Patients with a history of chronic hepatitis B or C infection, HIV infection.
7. Clinically significant disorder that may unsuitable for study participation.
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method