Allergic rhinitis Respiratory Allergic rhinitis, unspecified
Conditions
Interventions
This will be a three-arm open-label non-inferiority randomized control trial in patients with allergic rhinitis. Consecutive consenting sample method will be followed to select participants of the arm
Sponsors
University of Colombo
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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) 2. Serum Immunoglobulin E level measured using chemiluminesent enzyme immunoassay (EIA) at baseline and after intervention | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Mean score of daytime nasal symptom score 2. Mean score of nighttime nasal symptom score 3. Mean score of non-nasal symptoms Patient self-rated symptom scores (daily rhinitis diary card) and allergic rhinitis grading symptoms collected on a weekly basis during the assessment period. The measurement of symptoms on a 4-point rating scale with the following definition will be used: • 0 = absent symptoms (no sign/symptom evident) • 1 = mild symptoms (sign/symptom clearly present, but minimal awareness; easily tolerated) • 2 = moderate symptoms (definite awareness of sign/symptom that is bothersome but tolerable) • 3 = severe symptoms (sign/symptom that is hard to tolerate; causes interference with activities of daily living and/or sleeping) 4. Health-related quality of life measured using HRQoL questionnaire (Valero et al, 2009 & 2013) at baseline and end of intervention (after four weeks, one month of follow up and two months of follow up) | — |
Countries
Sri Lanka
Contacts
Public ContactPathirage Kamal Perera
Outcome results
None listed