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Clinical Trials/CTRI/2021/02/031045
CTRI/2021/02/031045
Completed
Phase 3

A prospective, multicenter, double blind, placebo controlled randomized clinical trial to evaluate efficacy and safety of Sinuset tablets in patients suffering from Sinusitis and/or Allergic Rhinitis - CT-IR-AR- 2020

BHARGAVA PHYTOLAB0 sites100 target enrollmentTBD
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ConditionsHealth Condition 1: J019- Acute sinusitis, unspecified

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Health Condition 1: J019- Acute sinusitis, unspecified
Sponsor
BHARGAVA PHYTOLAB
Enrollment
100
Status
Completed
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
September 30, 2021
Last Updated
4 years ago
Study Type
Interventional

Investigators

Sponsor
BHARGAVA PHYTOLAB

Eligibility Criteria

Inclusion Criteria

  • •Subject is willing and able to give written informed consent.
  • •Patients of either sex aged between 18 to 65 years
  • •Subject having clinical diagnosis as per investigatorâ??s judgment for Acute or Chronic Sinusitis and/or Allergic Rhinitis.
  • •Subjects of childbearing potential should have a negative Pregnancy test at Screening.
  • •Female subjects of childbearing potential should be willing to practice appropriate birth control during the entire duration of the study.
  • •Appropriate birth control is defined in the study as any medically recommended method (or combination of methods) except oral birth control pills as per standard of care.
  • •Subject is willing, able and likely to comply with all study procedures and restrictions.

Exclusion Criteria

  • •Patients who are suspicious or diagnosed for pneumonia
  • •Patients with chronic bronchitis, Chronic Obstructive Pulmonary Disease (COPD), bronchiolitis, asthma, bronchial asthma or other LRTI
  • •Patients with Deviated Nasal Septum
  • •Patients with active infection who needs administration of antibiotics
  • •Patients with myocardial infarction, congestive heart failure
  • •Patients with renal disorder or liver disorder
  • •Patients with hypotension or hypertension
  • •Patients with history of epilepsy
  • •Patients with hyperthyroidism
  • •Patients with gastroduodenal ulcer

Outcomes

Primary Outcomes

Not specified

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