Health Condition 1: J393- Upper respiratory tract hypersensitivity reaction, site unspecified
Conditions
Interventions
Intervention1: Curcumin: Curcunan® is an extract obtained from Curcumin longa. The curcumin extract contains 95% Curcuminoids and Tetrahydro curcuminoids. It is a 500 mg capsule which will be consume
Sponsors
Dr. Willmar Schwabe India Pvt. Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and female participants aged 18-50 (both ages inclusive) 2. Participants with a BMI >=18.5 and 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 ( 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
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. 10. Subjects with COVID infection in the last 30 days. 11. Abstinence from any home-based remedies for common cold such as steam inhalation, decoctions, vapor rub, etc. 12. Presence of uncontrolled type 2 diabetes and hypertension. 13. Vaccination against influenza or swine flu within 3 months prior to screening 14. Those who have taken or should be taking or are taking antibiotics, antivirals, steroids, nasal decongestants, antihistamines, NSAIDS (paracetamol) or other medications that are expected to alleviate cold symptoms within two weeks prior to randomization. 15. History of any significant neurological and psychiatric condition which may affect the participation and inference of the studyâ??s end points. 16. Participation in other clinical trials in the last 30 days prior to screening. 17. Participants with 3 months history of chronic smoking, alcohol, or drug abuse. 18. Females who are pregnant/planning to be pregnant/lactating or taking any oral contraceptives. 19. Any condition that could, in the opinion of the investigator, preclude the participantâ??s ability to complete the study successfully and safely or that may confound study outcomes.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Change in quality of life by WURSS-21 questionnaire in comparison to placebo 2. Change in hs-CRP in comparison to placebo. 3. Change in Erythrocyte Sedimentation Rate (ESR) in comparison to placebo. 4. Change in the severity of Symptoms of URTI episodes as analyzed by WURSS-21 Questionnaire in comparison to placebo. 5. Number of days with fever using patient diary in comparison to placebo. 6. Duration of usage of any rescue medication using patient diary in comparison to placebo. 7. Unscheduled visits to physicians using patient diary in comparison to placebo. 8. Absence from work using patient diary in comparison to placebo. 9. Hospital admissions (number of days in the hospital and number of hospitalization) using patient diary in comparison to placeboTimepoint: 1. Every day for 10 days during demonstration of symptoms at each episode throughout the study. 2. Day 1, Day 10, and Day 90. 3. Day 1, Day 10, and Day 90. 4. Throughout the study. 5. Throughout the study. 6. Throughout the study. 7. Throughout the study. 8. Throughout the study. 9. Throughout the study. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Vitals (Blood pressure, body temperature and pulse rate) 2. Complete Blood Count [Haematology-WBC count, RBC count, haemoglobin, haematocrit, platelet count, differential count (neutrophils, eosinophils, basophils, monocytes, lymphocytes)] 3. Urine Analysis (pH, ketone bodies, nitrite, colour, appearance, specific gravity) 4. AE/SAETimepoint: 1. Screening, Day 1 (Baseline), Day 10, Day 45, Day 90, And Day 120. 2. At time points: Day 1 and Day 90. 3. At time points: Day 1 and Day 90 4. Throughout the study | — |
Countries
India
Contacts
Public ContactSubham Dutta
Syncorp Health Pvt Ltd
Outcome results
None listed