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 个研究点分布在 1 个国家目标入组 60 人开始时间: 2020年2月11日最近更新: 2020年10月30日

试验速览

阶段: 2/3 期
状态: 尚未招募
发起方
入组人数: 60
试验地点: 1
主要终点: Total Nasal Symptom Score (TNSS)

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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.

研究设计

研究类型: Interventional
分配方式: Permuted block randomization, fixed
盲法: Participant and Investigator Blinded

入排标准

年龄范围: 18.00 Year(s) 至 65.00 Year(s)（—）
性别: All

入选标准

•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.

排除标准

•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.

结局指标

主要结局

Total Nasal Symptom Score (TNSS)

时间窗: baseline, 1st week, 2nd week, 3rd week and 4th week

次要结局

Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)(baseline, 1st week, 2nd week, 3rd week and 4th week)

研究者

发起方

Mahesh Bhattacharyya Homoeopathic Medical College Hospital

申办方类型

Government medical college

研究点 (1)

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