Comparing the effect of two Ayurveda drugs on the treatment of allergic rhinitis

Phase 2

• Conditions: Respiratory; Allergic rhinitis, unspecified; Allergic rhinitis

• Registration Number: ISRCTN18149439
• Lead Sponsor: niversity of Colombo

Brief Summary

2020 protocol in https://pubmed.ncbi.nlm.nih.gov/31910896/ (added 04/08/2020)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-05-02
• Last Update Posted: 17 August 2020
• Study Completion: 2021-05-01

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 210

Inclusion Criteria

1. Age 18-65 years at the time of enrollment, of either sex
2. No known systemic disorders
3. Newly diagnosed allergic rhinitis patients on Ayurvedic treatment
4. No history of drug allergy
5. Non-pregnant and non-breastfeeding
6. Have given written informed consent to participate in this study
7. Total Nasal Symptom Score (TNSS) more than 6

Exclusion Criteria

1. Patients with deviated nasal septum/nasal polyps/nasal growth/adenoids/asthma
2. Patients with impaired liver and kidney functions, anaemia, and unstable cardiovascular conditions or cerebrovascular conditions
3. Currently or previously treated for any malignancy
4. Patients on steroid therapy
5. Already on treatment with herbal decoction or antihistamines
6. Pregnant or lactating mothers
7. Illiterate patients without a literate relative/guardian who can explain the procedures and maintain the patient diary

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 1. Nasal symptoms (watery rhinorrhea, sneezing, nasal obstruction, nasal itching) measured using the Total Nasal Symptom Score (TNSS) of allergic rhinitis patients at baseline and the end of intervention (after four weeks, after one month of follow up and two months of follow up)<br> 2. Serum Immunoglobulin E level measured using chemiluminesent enzyme immunoassay (EIA) at baseline and after intervention<br>