Health Condition 1: J988- Other specified respiratory disorders
Conditions
Interventions
Intervention1: FDC of Noscapine 15 mg plus Chlorpheniramine Maleate 4 mg Oral Syrup: Patients will be advised to take 5 mL of oral syrup 4 times daily for 7 days.
Control Intervention1: FDC of Dextrom
Sponsors
Biological E Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female patients aged between 12 to 65 years (both inclusive). 2. Patients with a diagnosis of dry, irritating cough associated with running nose at screening visit. 3. Women of childbearing potential (WOCBP) must be using an acceptable method of contraception to avoid pregnancy throughout the study. WOCBP must have a negative urine pregnancy test at screening / baseline visit. 4. Patient with ability to understand and provide written informed consent / assent form, which must have been obtained prior to screening. 5. Patients willing to comply with the protocol requirements throughout the study.
Exclusion criteria
Exclusion criteria: 1. Patients with hypersensitivity to either of the study medications or any of the ingredients of the formulation. 2. Patients who had initiation of allergen immunotherapy within previous 6 months. 3. Patients with history of Rhinitis medicamentosa or substantial structural nasal obstruction. 4. Patients with the presence of nasal polyps or any clinically important nasal anomaly. 5. Patients with the history of acute and/or chronic sinusitis within 30 days of baseline/screening visit. 6. Patients with the history of eye surgery or intranasal surgery within 3 months of baseline/screening visit. 7. Patients with severe asthma requiring emergency room treatment within 1 month or hospitalization within 3 months before the trial. 8. Female patients who are pregnant or lactating or planning to become pregnant during the study period. 9. Female patients who are not ready to use acceptable contraceptive methods during the study. 10. Patients with known case of HIV, Hepatitis B & C. 11. Patients with medical history of oncological conditions. 12. Patients with current evidence of clinically significant hematopoietic, cardiovascular, hepatic renal, neurologic, psychiatric, autoimmune disease, or other disease that precludes the patientââ?¬•s participation in the study. 13. Patients with concurrent participation in another clinical trial or any investigational therapy within 30 days prior to screening visit. 14. Patients currently taking prohibited medications(s) listed and inability/unwillingness to discontinue them for the entire study period. 15. Patients with suspected inability or unwillingness to comply with the study procedures. 16. Patients with any condition which, in the judgment of the Investigator, may render the patient unable to complete the study or which may pose a significant risk to the patient.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in cough severity score (CSS) from baseline to end of the study visit.Timepoint: At Visit 1 / Day 1 and Visit 3 / Day 7. | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events or Serious adverse events reported during the study. Timepoint: At Visit 2 / Day 3 and Visit 3 / Day 7.;Change in Leicester Cough Questionnaire (LCQ) from baseline to end of the study visit.Timepoint: At Visit 1 / Day 1 and Visit 3 / Day 7.;Changes in clinical laboratory parameters from baseline to end of the study visit.Timepoint: At Visit 1 / Day 1 and Visit 3 / Day 7.;Mean change in cough severity score (CSS) from baseline to day 3.Timepoint: At Visit 1 / Day 1 and Visit 2 / Day 3.;Percentage change in cough severity score (CSS) from baseline to day 3 and end of the study visit.Timepoint: At Visit 1 / Day 1, Visit 2 / Day 3 and Visit 3 / Day 7.;Runny nose severity assessment from baseline to end of the study visit.Timepoint: At Visit 1 / Day 1 and Visit 3 / Day 7. | — |
Countries
India
Contacts
Public ContactDr Siddalingaiah N
Biological E Limited
Outcome results
None listed