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.
Investigators
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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