Ayurvedic treatment of chronic sinusitisPurpose:This is a research study with a view to scientifically document the clinical efficacy and safety of the said Ayurvedic formulation that has been in use since thousands of years for the management of the Chronic Rhinosinusitis.

Phase 2

Completed

• Conditions: Health Condition 1: R098- Other specified symptoms and signsinvolving the circulatory and respiratory systems

• Registration Number: CTRI/2019/04/018509
• Lead Sponsor: CCRAS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 0

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
a) Primary â?? <br/ ><br>ï?¶Change in SNOT (Sino-Nasal Outcome Test) scores <br/ ><br>Timepoint: At Baseline, at 42th Day and at 70th Day

Secondary Outcome Measures

Name	Time	Method
Change in RSDI (Rhinosinusitis Disability Index) scores. <br/ ><br> <br/ ><br>Change in Lund-Mackay score of CT scan PNS.Timepoint: At Baseline, at 42nd Day and at 70th day (Follow up visit) <br/ ><br> <br/ ><br>CT Scan- At Baseline and at 42nd Day