Health Condition 1: J208- Acute bronchitis due to other specified organisms
Conditions
Interventions
Intervention1: Group 1: cardamom extract capsules (200mg): Dosage form : capsule
Dose: 200mg
frequency : three times daily for a period of 10 days
Intervention2: Group 2: 1,8 cineole (200mg),: Dosage
Sponsors
Zum Heilen Diagnostic Therapeutics ZH DT
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age group 19 â?? 70 yrs 2. Subjects of both male and females involved 3. Patients with acute respiratory infections 4. Subjects who are willing to provide written consent for the study 5. Mild to Moderately severe disease (NEWS score Less than/equal to 8) 6. Can take oral medicines 7. Subject willing to abide by and comply with the study protocol
Exclusion criteria
Exclusion criteria: 1. Subjects less than 17 years and above 70yrs old 2. Pregnancy and lactation 3. Patients with existing history of other inflammatory disease conditions 4. Patients currently taking anti-inflammatory drugs and 5. Immune-compromised subjects 6. Severe or complicated lung disease/infection 7. Presence of acute hypoxic respiratory failure/ need for Intensive care unit (ICU) stay/ Patients who need mechanical ventilation. 8. Any uncontrolled systemic disease, infection 9. Those with serious Cardiovascular, Cerebrovascular, Respiratory, Liver or Renal disease or any other disorder. 10. Other conditions, which in the opinion of the investigators makes the patient unsuitable for enrolment or could interfere in adherence to of the study protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Change in the expression of inflammatory markers (IL-6, TNF-α, IFNγ, MIP1α, MIP1β, MCP1, IP-10, IL-1β) using RT-PCR analysis in ARI patients from baseline to end of studyTimepoint: Day 0, day 3, day 5 and day 10 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Adverse events (AEs), frequency and severity from baseline to end of study 2. Number of subjects who discontinue study due to adverse events at day 10 3. Changes in vital parameters and safety laboratory parameters (liver function test, renal function test, serum electrolyte) from baseline to day 10 Timepoint: Day 0 and Day 10 | — |
Countries
India
Contacts
Public ContactDr Prashanth Varkey
Zum Heilen Diagnostic and Therapeutics
Outcome results
None listed