Health Condition 1: F411- Generalized anxiety disorder
Conditions
Interventions
Intervention1: FDC of Chlordiazepoxide and trifluoperazine: Dose-fixed-dose combination of Chlordiazepoxide 10mg/5 mg/5 mg and Trifluoperazine 1 mg/1 mg/0.5 mg
Route of administration- Oral
Frequency
Sponsors
A N Pharmacia Laboratories Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Both Male and Female patients. 2. Ages: > 18 years and =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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessment based on HAMA scale, Clinician Global Impression (CGI) and Patient Global Impression (PGI) scalesTimepoint: 14 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluate efficacy of this FDC in treatment of Chronic Anxiety and Insomnia.Timepoint: 14 days | — |
Countries
India
Contacts
Public ContactDr Nimesh Patel
Sanjeevani Heart & Medical Hosptial
Outcome results
None listed