CTRI/2023/06/053472
Not yet recruiting
未知
A prospective, randomized, double-blind study to evaluate the efficacy of Curcunan® on Upper Respiratory Tract Infections (URTIs) and its recurrence along with its effect on immunity.
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Dr. Willmar Schwabe India Pvt. Ltd.
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Male and female participants aged 18\-50 (both ages inclusive)
- •2\. Participants with a BMI \>\=18\.5 and \<\= 30\.0 kg/m2\.
- •3\. Suffering from URTI i.e., at least 6 URTIs episodes medically confirmed, with a maximum of 12 within 1 Year before the study and must be presenting with the below symptoms of URTI ( \< 2 days of onset):
- •i) Runny nose/Nasal congestion
- •ii) Headache
- •iii) Low\-grade fever
- •iv) Sneezing.
- •4\. Participant must be able \& willing to comply with study procedures.
- •5\. Participant willing to sign the informed consent.
Exclusion Criteria
- •1\. Known sensitivity to the investigational product or any excipients of the drug product.
- •2\. Persistent fever more than 1020F.
- •3\. Signs of acute lower respiratory tract disease.
- •4\. Current symptoms are mainly induced by other acute ENT diseases.
- •5\. Daily use of antibiotics, steroids, and cytotoxic agents.
- •6\. Patients on active treatment from any other system of medicine.
- •7\. Patients with any uncontrolled systemic disease, infection, and any organ failure.
- •Severe co morbidity including previous malignant disease during the past 3\-year prior enrolment.
- •8\. Severe or complicated course of URTI (stridor, laryngomalacia, etc.)
- •9\. History of rhinitis medicamentosa, anatomical nasal obstruction or deformity, nasal reconstructive surgery, etc.
Outcomes
Primary Outcomes
Not specified
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