CTRI/2020/11/028785Not yet recruitingPhase 2/3
Individualized Homoeopathic Treatment in Allergic Rhinitis by using the KENTs Repertory: A Randomized, Double-blind, Placebo-controlled Clinical Trial
Mahesh Bhattacharyya Homoeopathic Medical College Hospital1 site in 1 country60 target enrollmentStarted: February 11, 2020Last updated:
Trial Snapshot
- Phase
- Phase 2/3
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Total Nasal Symptom Score (TNSS)
Study Overview
Brief Summary
Allergic rhinitis (AR) is a major problem worldwide and millions of people are suffering from this condition. Homoeopathy has long been recognised for its effectiveness in AR. However, very few clinical trials are there evaluating the effect of Individualised Homoeopathy in AR cases. This study has been taken up to demonstrate the feasibility and effect of IH in such cases. The trial will be conducted in strict adherence to the Helsinki’s human declaration protocol. The results of this study will be of much interest to the therapeutic modalities for AR.
Study Design
- Study Type
- Interventional
- Allocation
- Permuted block randomization, fixed
- Masking
- Participant and Investigator Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •1.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.
- •2.Subject must be symptomatic at screening and willing to maintain same environment throughout the study.
- •3.Ability to read and write English or Bengali 4.Ability and willingness to comply with study procedures.
Exclusion Criteria
- •1.Having complications of the nasal disease, or vasomotor rhinitis, rhinitis with eosinophilia, or drug rhinitis 2.Having complications of bacterial/viral infection of the upper respiratory tract 3.Having a significant systemic disease or any organ failure.
- •4.Subject suffering from any life threatening/Psychiatric/ illnesses or Immuno-compromised state or other significant disease conditions.
- •5.Pregnant or lactating woman 6.Substance abuse or dependence 7.Patients planning to travel outside the region 8.Patients who participated in another study within 4 months before screening 9.Patients taking drugs for other illness 10.Patients who have taken any homoeopathic medicines in the 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
- Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)(baseline, 1st week, 2nd week, 3rd week and 4th week)
Investigators
Study Sites (1)
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