Efficacy of Individualized Homoeopathic medicines in the Treatment of Allergic Rhinitis (Aeropalynological Studies of Purulia District): A Double-Blind, Randomized, Placebo-Controlled Trial.
Overview
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- DEPARTMENT OF SCIENCE & TECHNOLOGY AND BIOTECHNOLOGY VIGYAN CHETANA BHAVAN GOVERNMENT OF WEST BENGAL
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Total Nasal Symptom Score (TNSS)
Overview
Brief Summary
Allergic rhinitis (AR) is a disorder in with episodes of nasal congestion watery nasal discharge and sneezing. It may be seasonal or perennial, and is due to an immediate hypersensitivity reaction in the nasal mucosa. According to IUIS allergen nomenclature subcommittee over 150 pollen allergens from different weeds, grasses and trees are observed. More than 25% population in Indian is suffering from several types of allergies.
Several trials have evaluated the effectiveness of homeopathy for AR. Results from these trials are mixed. Collectively, the results of these trials have been noted to be positive. A systematic review and meta-analysis reported efficacy of homoeopathic medicines in treating AR. In an single arm interventional study by Ghosh et al. reported improvement in chronic allergic rhinitis symptoms, IgE and Absolute eosinophil count after homoeopathic treatment. No double-blind trial has been found in the Indian context. So, this trail will be conducted on 60 participants on a specified population (Aeropalynological Studies of Purulia District) to evaluate the effect of homoeopathic treatment beyond placebo at the Out-patient SHD Sadar at Deben Mahata Government Medical College and Hospital and Sidho-Kanho-Birsha University, Purulia. Assessment will be done by Total Nasal Symptom Score -TNSS (Primary outcome), Rhinoconjunctivitis Quality of Life Questionnaire -RQLQ and IgE estimation (Secondary outcome). Comparative analysis will be carried out to detect group differences. The results will be published in scientific journal.
Study Design
- Study Type
- Interventional
- Allocation
- Permuted block randomization, variable
- Masking
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Patient suffering from Allergic rhinitis (AR) for at least 1 year.
- •Confirmative diagnosis of AR by medical history, symptoms, skin prick tests (SPTs) or other biochemical parameters.
- •Subject must be symptomatic at screening and willing to maintain same environment throughout the study.
- •Patients of both sexes; age 18-65 years.
- •Ability to read and write English or Bengali
- •Ability and willing to comply with study procedures.
Exclusion Criteria
- •Having complications of nasal disease, or vasomotor rhinitis, rhinitis with eosinophilia, or drug rhinitis
- •Having complications of bacterial/viral infection of upper respiratory tract
- •Having significant systemic disease or any organ failure.
- •Subject suffering from any life threatening/Psychiatric/ illnesses or Immuno-compromised state or other significant disease conditions.
- •Pregnant or lactating woman
- •Substance abuse or dependence
- •Patients planning to travel outside the region
- •Patients taking drugs for other illness
- •Patients who have taken any homoeopathic medicines in last 3 months.
Outcomes
Primary Outcomes
Total Nasal Symptom Score (TNSS)
Time Frame: Baseline, 1st week, 2nd week, 3rd week and 4th week
Secondary Outcomes
- IgE estimation(Baseline and end point of study)
- Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)(Baseline, 1st week, 2nd week, 3rd week and 4th week)