A Study to Examine the Effects of Two Ayurvedic Formulations in the Treatment of Hay Fever: Allergy Rakshak Avaleha Alone and Allergy Rakshak Avaleha Combined with Allergy Rakshak Ghee

Phase 3

Conditions: Health Condition 1: J309- Allergic rhinitis, unspecified

Registration Number: CTRI/2024/05/067447

Lead Sponsor: Arogyam Ayurvedic Allergy Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

Allergic rhinitis patients of both genders, aged between 18 and 65 years at the time of enrollment

Presence of 2 or more nasal symptoms (sneezing, watery rhinorrhea, nasal congestion, and nasal itching)

Total Nasal Symptom Score (TNSS) greater or equal to 2 (TNSS is calculated by adding scores for each nasal symptom on a four-point scale (0 means no symptoms, 1 means mild symptoms, 2 means moderate symptoms, 3 means severe symptoms), with a maximum TNSS of 12)

Exclusion Criteria

Patients with deviated nasal septum, nasal polyps, or any clinically significant nasal anomaly

Presence of upper respiratory tract infections or severe asthma, impaired hepatic and renal functions, abnormal cardiovascular or cerebrovascular conditions, or anemia, or a history of known systemic disorders

Currently or previously treated for malignancy

Undergoing steroid therapy

Already receiving medications for allergic rhinitis or receiving antihistamines

Known allergies to investigational products or their ingredients

Pregnant or lactating mothers

Any other individuals deemed unsuitable for inclusion by the investigators

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in Total Nasal Symptom Score (TNSS), serum IgE levels, and eosinophil countTimepoint: TNSS: 28 days and after 1 month of follow up; Serum IgE levels and eosinophil count: 28 days

Secondary Outcome Measures