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Clinical Trials/CTRI/2021/09/036300
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

Sponsor
ITC Life Sciences and Technology Centre

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