Health Condition 1: J988- Other specified respiratory disorders
Conditions
Interventions
Intervention1: Codeine Phosphate 10mg and Chlorpheniramine Maleate 4mg: Codeine Phosphate 10mg and Chlorpheniramine Maleate 4mg per 5 ml syrup two times daily for 7 days
Control Intervention1: NOT APP
Sponsors
LABORATE Pharmaceuticals India Limited
LABORATE Pharmaceuticals India Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male & female (non-pregnant, non-lactating, post-menopausal, surgically sterilized or practicing a reliable method of birth control during the duration of study) Subjects with age ranging from 18 to 65 years (both inclusive). 2. Subjects having dry cough (less than 7 days) of any origin and may be with related symptoms as Throat Pain, throat redness, Throat irritation/itching, (Fever if present) (absence of bronchial mucus/phlegm production). 3. Not under any antibacterial or antiviral treatment before recruitment. 4. Subjects ready to abstain from using any drug (which will affect the study outcome) other than Investigational Product for the treatment of the study condition during the study period (except in cases when patientââ?¬•s condition worsens as per study physician. In this case, Study physician will decide to prescribe antibiotic, if required). 5. Ready to abstain from the administration of any herbal or ayurvedic treatment or gargles directed to ease coughing or throat parameters. 6. Willing to provide written informed consent 7. Willing and able to understand and comply with all study requirements
Exclusion criteria
Exclusion criteria: 1. Subjects with known allergy or hypersensitivity to Codeine Phosphate or Chlorpheniramine Maleate or any of its components. 2. Subjects who had taken any medicated confectionary, throat pastille, spray or any product with demulcent properties, any cough medicines or drugs containing antihistamines within last 24 hours prior to screening. 3. Subjects taking medications with known cough promoting side effects (e.g., angiotensin converting enzyme inhibitors or angiotensin II receptor blockers) that in the opinion of the investigator are causing symptoms of cough. 4. Subjects with diagnosis of diseases of pneumonia, asthma, sinusitis, allergic rhinitis, as well as heart disease. 5. Severe cough requiring hospitalization 6. Subjects who had used any local anesthetic within the past 24 hours. 7. Subjects who have used a longer acting or slow release analgesic during the previous 24 hours. 8. Maintenance therapy with any drug, or history of drug dependency, alcohol abuse, or serious neurological or psychological disease 9. Any other condition, which in the opinion of the clinician/investigator, could interfere significantly with the treatment and assessment process 10. Use of any investigational therapy within 30 days prior to randomization
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse Events, Serious Adverse Events, Unexpected Adverse Events, Adverse Drug Reactions and Treatment Emergent Adverse Events. Timepoint: 7 Days | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in score of throat pain and throat irritationTimepoint: Day 7;Change in the cough severity( daily) and frequency (daily) score assessed during follow-up visit at Day 3 and Day 7 or up to complete recovery (whichever is earlier) compared to the baseline.Timepoint: Day 3 and Day 7;Number of awakenings in the night due to cough (24 hours) assessed during follow-up visitTimepoint: Day 7;Time taken for complete cough relief (days) assessed during follow-up visitTimepoint: Day 7 | — |
Countries
India
Contacts
Public ContactDr R M Chhabra
Insignia Clinical Services Pvt. Ltd.
Outcome results
None listed