CTRI/2021/09/036300Completed未知
A Double-Blind, Randomized, Parallel Clinical Study to Evaluate the Efficacy and Safety of Nasal Spray in Adult Subjects With Symptoms of Common Cold
ITC Life Sciences and Technology Centre0 sites120 target enrollmentStarted: TBDLast updated:
Trial Snapshot
- Phase
- 未知
- Status
- Completed
- Sponsor
- Enrollment
- 120
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
Inclusion Criteria
- •1.Subject in an early stage of a common cold with symptoms evidenced less than 48 hours. TSS at baseline less than 9 and a score of greater than 1 for at least one of the following symptoms: sore throat, runny nose or blocked nose.
- •2.Subject who agrees to refrain from taking any products intended to prevent, intervene in, or treat
- •cough, colds, flu during the study period.
- •3. Female subject who is non-pregnant, non-lactating, postmenopausal, surgically sterilized, or using a medically acceptable form of birth control, as determined by the investigator.
- •4. Subject willing to give informed consent and comply with the study procedures.
Exclusion Criteria
- •1. Subjects with History of Clinically significant Disorder
- •2.Subject having tested positive for SARS-CoV-2 by Rapid antigen testing on a nasopharyngeal or
- •oropharyngeal swab during the screening visit.
- •3.Subjects who test negative for viral load (Rhino virus, Influenza A, B, Human Coronavirus) at baseline.
- •4.Subjects categorized with severe symptoms.
- •5. Subject having taken influenza vaccination within the last 3 months prior to Screening visit.
- •6.Subject having common cold or flu like symptoms for more than 48 hours.
- •7. Subject under regular use of products that may influence the study outcome
- •8. Pregnant and lactating women.
- •9. Subjects allergic to herbal products or any component of the study product.
- •10. Subjects currently participating or having participated in another clinical trial during the last 3 months prior to the beginning of this study.
- •11.Any additional conditions that in the Investigators opinion would warrant exclusion from the study or prevent the subject from completing the study
Investigators
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