MedPath

Management of Allergic rhinitis

Phase 3
Conditions
Health Condition 1: J309- Allergic rhinitis, unspecifiedHealth Condition 2: J309- Allergic rhinitis, unspecified
Registration Number
CTRI/2023/06/053395
Lead Sponsor
Central Council for Research in Ayurvedic Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Yet Recruiting
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

1.Patients either sex ages between 18 to 65 years.

2.IAR or PER (as per the internationally recognized diagnostic standard ARIA), diagnosed by medical history . (Annexure I)

3.Able and willing to participate and provide signed informed consent.

Exclusion Criteria

1.History of chronic nasal or upper respiratory tract symptoms or disorders other than allergic rhinitis.

2.History of non allergic rhinitis, chronic sinusitis or serve bronchial asthma.

3.Patients with nasal anatomical defects (grossly deviated nasal septum).

4.Patients with Nasal Polyposis.

5.Patients with associated tonsillitis or airway obstructions (adenoids).

6.Has a nasal condition likely to affect the outcome of the study.

7.Any treatment of H1 antihistamine medication, Non-steroidal analgesics. Corticosteroids Nasal drops, Leukotriene antagonists, Nasal vasoconstrictors.

8. Patients with a history of surgical procedure on the nose like Septoplasty/Submucous resection, Inferior turbinate reduction, Endoscopic sinus surgery.

9.Pregnant ladies and Lactating mothers.

10.Patients suffering from any debilitating chronic disease like tuberculosis, Uncontrolled Diabetes mellitus

11.Any unstable cardio-vascular diseases

12.Patients with evidence of malignancy.

13.Patients with concurrent hepatic disorder (defined as Aspartate Amino Transferase (AST) and / or Alanine Amino Transferase (ALT) > 2 times upper normal limit or Renal Disorders (defined as S. creatinine > upper limit of Lab. value), Pulmonary Dysfunction (Bronchial Asthma and / or Chronic Obstructive Pulmonary Disease [COPD])

14.Patient has an acute mental disorder

15.Patients who are currently participating in any other clinical trial.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
oMean change in the CARAT (Control of Allergic Rhinitis and Asthma Test) ScoreTimepoint: On base line, 16th day, 31st day, 45th day, 75th day, 105th day, 135th day
Secondary Outcome Measures
NameTimeMethod
oMean change in the Nasal Endoscopy Index (assessment of nasal membrane color (pale or hyperemia), rhinorrhea (watery or yellow), and inferior turbinate swelling (hypertrophy). <br/ ><br>oMean change in the Laboratory investigations <br/ ><br>Timepoint: On baseline and 45th day <br/ ><br>
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