Health Condition 1: R098- Other specified symptoms and signsinvolving the circulatory and respiratory systems
Conditions
Interventions
Intervention1: Shadbindu Taila
Chitraka Haritaki Avaleha: a) Shadbindu Taila
Dose : 6 Bindu in each nostril
Dosage form : Taila
Route of Administration : Each nostril
Time of Administration : On
Sponsors
CCRAS
Eligibility
Inclusion 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. AND 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. 3. Willing to give written informed consent for the participation.
Exclusion criteria
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). 11. Alcoholics and/or drug abusers. 12. Pregnant women and Lactating mothers. 13. Patients who have completed participation in any other clinical trial during the past six months. 14. Any other condition which the investigator thinks may jeopardize the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| a) Primary â?? ï?¶Change in SNOT (Sino-Nasal Outcome Test) scores Timepoint: At Baseline, at 42th Day and at 70th Day | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in RSDI (Rhinosinusitis Disability Index) scores. Change in Lund-Mackay score of CT scan PNS.Timepoint: At Baseline, at 42nd Day and at 70th day (Follow up visit) CT Scan- At Baseline and at 42nd Day | — |
Countries
India
Contacts
Public ContactDr Mata Shweta Pradipbhai
CARICD, CCRAS, under ministry of AYUSH, Govt. of India, New Delhi
Outcome results
None listed