Health Condition 1: J00-J99- Diseases of the respiratory system
Conditions
Interventions
Intervention1: Pelargonium sidoides extract Malva sylvestris dry extract: Gummies with active ingredient has to be taken orally 3 times (morning, afternoon and night before sleeping) a day for 10 days
Sponsors
Giellepi Spa
Eligibility
Inclusion criteria
Inclusion criteria: 1.Patient should be able to give written informed consent. 2.Diagnosis of persisting cough (Cough Clinical Score of 3) 3.Males and females, 18-65 years of age (both inclusive) 4. Ability to comply with requirements of trial. 4.Persisting cough (at least 7 days up to 3 weeks, not treated with any antitussive product)
Exclusion criteria
Exclusion criteria: Subjects having TB, COPD or Asthma, pulmonary fibrosis, lung cancer or chest X-ray showing lung problems. 2. Known history of drug or alcohol abuse. 3. Subjects who, in the opinion of the investigator, are mentally incapacitated such that informed consent cannot be obtained. 4. Pregnant and lactating women. 5. Subjects with clinically significant history of co-morbid condition (like, diabetes, immunodeficiency, HIV, HPV) that in the opinion of the investigator could affect the efficacy and safety outcome of the study. 6. Patients suffering from any condition which in opinion of the Investigator may interfere with the outcome for the study. Subject with deteriorating health status at the time of enrolment, rapid weight loss, terminal disease, significant chronic disease. 8. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) values >= 2.5 X Upper Limit of Normal (ULN), Serum creatinine of >= 1.5 mg/dL. 9. Subjects on Hormone replacement therapy or chemotherapy or radiotherapy. 10. Subjects participating in any other studies or participated in any clinical trial 3 months prior to start of this trial. 11. Known hypersensitivity to, or intolerance of, study products or their formulation excipients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To demonstrate that Investigational product is more effective than placebo for the management persisting cough. An improvement of 2 score (Cough Clinical Score) is expected in 25% of subjects treated with investigational product.Timepoint: Screening Day 0 Day 5 and Day 10 | — |
Secondary
| Measure | Time frame |
|---|---|
| improvement of day-time cough score from between active and placebo. Change in LCQ in between groups Change in Leicester Cough Questionnaire in between active and placebo and in between groups. Change in cough using VAS between active and placebo. Change in nocturnal cough and sleep quality between active and placebo. Change in short Form 36 item (SF36) Compliance and tolerability. Overall treatment satisfaction questionnaire.Timepoint: Screening Day 0 Day 5 and Day 10 | — |
Countries
India
Contacts
Public ContactDr Deepa Subramanian
Syncretic Clinical Research Services Pvt. Ltd
Outcome results
None listed