Health Condition 1: J069- Acute upper respiratory infection,unspecified
Conditions
Interventions
Intervention1: Group 1: For non Productive cough, Emcof Herbal Cough Syrup 5 ml thrice daily orally: 1. Adhatoda vasica – 10mg
2. Solanum xanthocarpum – 25mg
3. Piper nigrum – 10mg
4. Zingiber officin
Sponsors
Medopharm
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients willing to provide written informed consent to participate in the study 2. Male and Female patient in the age range of 10-65 years. 3. Patients with acute and Chronic,Productive or non-productive cough (Dry cough, Wet cough, Asthmatic cough, Allergic cough, Infective cough, Smokers cough, Sore throat, Hoarse cough, Ratting / Tickling cough) presenting in out patient setting. 4. Patients with a baseline daytime cough symptom score of at least 2.
Exclusion criteria
Exclusion criteria: 1. Female patient who is pregnant or lactating. 2. Patients or with clinically suspected lower respiratory tract infection (e.g. pneumonia tuberculosis) 3. Patients taking any other antitussives, sleeping pills, sedative medications, or herbal cough remedies; 4. Patients currently on any treatments that may influence cough. 5. Patient has history of hepatic or renal insufficiency 6. History of hypersensitivity to any of the test products. 7. Any condition decided as unfit for study by Clinical investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1)Change in the daytime cough symptom scores and cough rating scale at end of 5 days (120 hrs) of first examination as compared to the baseline 2. Change in Night time cough symptom scores and cough rating scale from the baseline to end of 5 days (120 hrs) of first examination as compared to the baseline 3. Reduction of pharyngeal(throat) pain(if present) before and at the end of 5 days- measured on Visual Analogue Scale (VAS) . [time frame: 5 days] 4. Use of rescue medication (Cough syrup). [time frame: 10 days] 5. Proportion of patients having a confirmed Best response or Partial Response or Complete response (10 days duration) 6. To assess the quality of life among the study participants using pre and post Study Leicester Cough Questionnaire (LCQ-acute) Adverse events and serious adverse events during the study period Brief clinical examinationTimepoint: Day 0, Day 2, Day 5 and Day 7 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1)To demonstrate safety and tolerability of study product by Clinical AEs (If any) 2)Proportion of patients having a confirmed Best response or Partial Response Or Complete response (10 days duration) 3)To assess the quality of life among the study participants using pre and post Study Leicester Cough Questionnaire (LCQ-acute)Timepoint: Day 0, Day 2, Day 5 and Day 7 | — |
Countries
India
Contacts
Public ContactDr Gayathri Sivakumar
Thirumalai medical Centre, ki3
Outcome results
None listed