Health Condition 1: J019- Acute sinusitis, unspecified
Conditions
Interventions
Intervention1: Sinuset tablets: Each tablet contains:
Asafoetida 12X 20.00
Lycopodium clavatum 3X 25.00
Pulsatilla nigricans 6X 20.00
2 tablets to be taken thrice daily orally for 14 days
Sticta pulm
Sponsors
BHARGAVA PHYTOLAB
Eligibility
Inclusion criteria
Inclusion criteria: Subject is willing and able to give written informed consent. Patients of either sex aged between 18 to 65 years Subject having clinical diagnosis as per investigatorâ??s judgment for Acute or Chronic Sinusitis and/or Allergic Rhinitis. Subjects of childbearing potential should have a negative Pregnancy test at Screening. Female subjects of childbearing potential should be willing to practice appropriate birth control during the entire duration of the study. Appropriate birth control is defined in the study as any medically recommended method (or combination of methods) except oral birth control pills as per standard of care. Subject is willing, able and likely to comply with all study procedures and restrictions.
Exclusion criteria
Exclusion criteria: Patients who are suspicious or diagnosed for pneumonia Patients with chronic bronchitis, Chronic Obstructive Pulmonary Disease (COPD), bronchiolitis, asthma, bronchial asthma or other LRTI Patients with Deviated Nasal Septum Patients with active infection who needs administration of antibiotics Patients with myocardial infarction, congestive heart failure Patients with renal disorder or liver disorder Patients with hypotension or hypertension Patients with history of epilepsy Patients with hyperthyroidism Patients with gastroduodenal ulcer Patients with severe hypoxemia Patients who are in drug or therapy or planned to have- Antibiotics, anti-virus, and systemic or inhalation glucocorticosteroids: from 2 weeks prior to administration of investigational product to termination of clinical trial Secretolytics/mucolytics, expectorants, antitussives, herbal medicines which has antitussive or expectorant effect: from 2 days prior to administration of investigational product to termination of clinical trial Analgesics except acetaminophen, antihistamines, β2-agonists, bronchodilators which includes anticholinergic agents, xanthine derivatives, central nervous system stimulants, drug which is known for interaction between acebrophylline (cimetidine, alloprinol, oral anticoagulants, furosemide, reserpine, barbiturates, phenytoin) and symptomatic therapy for other therapy for acute bronchitis: whole period for clinical trial Smokers Patients who have history for drug hypersensitivity or allergic reaction in component of investigational product or similar drug Patients who are pregnant and/or breast feeding. Patients with no intention to use appropriate contraceptives or has a plan to become pregnant Patients who had an administration of other investigational product or medical device for clinical trial 4 weeks prior to participation of clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the change or improvement in SNOT -20 (Sino Nasal Outcome Test)Timepoint: Day 0 to Day 14 | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety and tolerability of the study drug(s) will be assessed by the Clinical AEs occurring during entire duration of studyTimepoint: Day 0 to Day 14 | — |
Countries
India
Contacts
Public ContactDr Devesh Kumar
IR Innovate Research Private Limited
Outcome results
None listed