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Treatment of dry or productive cough

Multi-centric, Open label, Single arm, Clinical Study to Evaluate the Efficacy and Safety of Kafnorm® Syrup for Symptomatic Relief of Dry or Productive Cough.

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
CTRI
Registry ID
CTRI/2020/03/023788
Enrollment
50
Registered
2020-03-05
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: J22- Unspecified acute lower respiratory infection

Interventions

Intervention1: Kafnorm Syrup: Relief from dry or productive cough Route of administration: oral Frequency:10 mLThrice a day Dose:10mL Control Intervention1: NOT APPLICABLE: NOT APPLICABLE

Sponsors

Virgo UAP Pharma Pvt
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age 18â??50 completed years. 2. History of acute dry or productive cough 3. Cough score of 0,1,2 as per day time cough scale. 4. Willing to give written informed consent. 5. Able to comply with study requirements. 6. Female participants of child bearing potential and male participants whose partner is of child bearing potential must be willing to ensure that they or their partner use effective contraception during the study. 7. Patient willing to refrain from smoking, alcohol, etc.

Exclusion criteria

Exclusion criteria: 1. Age 2. Pregnant (as per urine pregnancy test) or lactating female patient. 3. Past history of drug abuse and alcohol consumption since last 6 months. 4. Symptoms of the cough for more than 1 week. 5. Known immune deficiency. 6. Lung disease (include asthma or COPD). 7. Other respiratory disorders like Tuberculosis, chronic bronchitis, asthma, suspected pneumonia, suspected bacterial infections etc. 8. History / current condition of Cardiac disease like cardiomegaly, myocardial infraction, mitral regurgitation etc. 9. Gastrointestinal symptoms such as nausea, vomiting, abdominal pain or diarrhea. 10. Difficulty in filling in the patient diary. 11. History of uncontrolled Diabetes Mellitus. 12. Current smoker, Smoking history >10 packs per month. 13. Patient who received other medications and antibiotic (give all details) for cough within 3 days prior to Investigation drug administration. 14. History of or patients taking any medication that causes cough. 15. History of homemade therapy and patient not willing to refrain from such medications, therapy, home-made therapy during the treatment phase. 16. Patient agreed to avoid such condition like certain foods like cold foods, cold drinks, cough induced lifestyle and cold environmental conditions.

Design outcomes

Primary

MeasureTime frame
Changes in day and night frequencies of cough: [Time frame: Baseline/Screening & 1, 2 & 3 days post-treatment] â?? Will be evaluated on 6 point scale in treated patient. 1. Change in throat irritation: [Time frame: Baseline/Screening & 1, 2 & 3 days post-treatment] â?? Will be evaluated on 6 point scale.Timepoint: 5 days

Secondary

MeasureTime frame
1. Duration of relief from symptoms 2. Time to relief from cough and throat irritation 3. Physicianâ??s global assessment of efficacyTimepoint: 5 days

Countries

India

Contacts

Public ContactDr Narsinh M Patel

Sanjeevani Heart And Medical Hospital

dr.patelnm@gmail.com8000445716

Outcome results

None listed

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