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Clinical Trials/CTRI/2019/04/018509
CTRI/2019/04/018509
Completed
Phase 2

Clinical evaluation of Shadbindu Taila Nasya and Chitraka Haritaki in the management of Pinasa (Chronic Rhinosinusitis)

CCRAS0 sites0 target enrollmentTBD

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Health Condition 1: R098- Other specified symptoms and signsinvolving the circulatory and respiratory systems
Sponsor
CCRAS
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional

Investigators

Sponsor
CCRAS

Eligibility Criteria

Inclusion Criteria

  • 1\.Patients of either sex with age between 18 and 60 years.
  • 2\.Known case of Chronic Rhinosinusitis as per American Academy of Otolaryngology\- Head and Neck Surgery Foundation (AAO\-HNS) criteria (Annexure I)
  • A.Twelve weeks or longer of two or more of the following signs and symptoms:
  • ï?¶mucopurulent drainage (anterior, posterior, or both), nasal obstruction (congestion),
  • ï?¶facial pain\-pressure\-fullness, or
  • ï?¶ Decreased sense of smell.
  • B.Inflammation is documented by one or more of the following findings:
  • ï?¶purulent (not clear) mucus or edema in the middle meatus or anterior ethmoid region,
  • ï?¶polyps in nasal cavity or the middle meatus, and/or
  • ï?¶Radiographic imaging showing inflammation of the paranasal sinuses.

Exclusion Criteria

  • 1\.Patients below 18 and above 60 years of age.
  • 2\.History of chronic nasal or upper respiratory tract symptoms or disorders other than Sinusitis.
  • 3\.Patients suffering with tonsillitis/adenoids.
  • 4\.Patients who are on treatment with H1 antihistamine medication, Non\-steroidal analgesics. Corticosteroids Nasal drops, Leukotriene antagonists, Nasal vasoconstrictors, or any other drugs that may have an influence on the outcome of the study.
  • 5\.Patients with uncontrolled Diabetes Mellitus (Blood Sugar Fasting \> 250 mg/dl).
  • 6\.Patients with poorly controlled Hypertension ( \>\=160 / 100 mmHg).
  • 7\.Patients suffering from major systemic illness necessitating long term drug treatment (Rheumatoid arthritis, Tuberculosis, Psycho\-Neuro\-Endocrinal disorders etc).
  • 8\.Patients who have a past history of Atrial Fibrillation, Acute Coronary Syndrome, Myocardial Infarction, Stroke or Severe Arrhythmia in the last 6 months.
  • 9\.Symptomatic patients with clinical evidence of Heart failure.
  • 10\.Patients with concurrent serious hepatic disorder (defined as Aspartate Amino Transferase (AST) and / or Alanine Amino Transferase (ALT), Total Bilirubin, Alkaline Phosphatase (ALP) \> 2 times upper normal limit) or Renal Disorders (defined as S. Creatinine \>1\.2mg/dL).

Outcomes

Primary Outcomes

Not specified

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