An Evidence-based Single-blind Randomized Controlled Trial Searching for the Efficacy of Homoeopathic Medicines in Reducing Serum Levels of Cytokines (IL - 10, 13) and Immunoglobulin E in Allergic Rhinitis and/or Induced Bronchial Asthma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Serum Interleukin 10 and 13 level
研究概览
简要总结
The purpose of this study is to test whether individualized homeopathic medicines can produce any significant effect beyond placebo in treatment of allergic rhinitis and/or induced bronchial asthma
详细描述
A prospective, single-blind (subject), randomized, placebo-controlled, parallel group, interventional clinical trial is being conducted on 100 participants (subjects 50, control 50) suffering from allergic rhinitis and/or induced bronchial asthma since March 1, 2012 at Mahesh Bhattacharyya Homeopathic Medical College and Hospital, Government of West Bengal. This trial is aimed at exploring the efficacy of homeopathic medicines in comparison with placebo in reducing serum interleukin 10, 13 and immunoglobulin E measured at timeline of 1 year of treatment and absolute eosinophil count every 4 months up to 1 year. Matching for independent and consequent variables will be done to test for bias. Parametric or non-parametric tests will be employed as per distribution of data at the end of the trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 5 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 5 and 65 years
- •Both sexes
- •Atopic: reactive to allergens with positive skin prick test (SPT) results and/or eosinophilia
- •More than 1 year history of allergic rhinitis and/or induced bronchial asthma
排除标准
- •Nasal abnormalities causing obstruction, e.g. nasal polyp(s), deviated septum etc.
- •Previous homoeopathic immunotherapy for allergic rhinitis
- •Allergen avoidance in past 6 weeks
- •Away from usual environment for more than 1 week during trial
- •Severe asthma cases as detected clinically
- •Respiratory infection
- •Severe concomitant disease
- •Pregnancy, breast feeding, or likelihood of pregnancy
- •Oral or parenteral steroids and/or decongestant in past 6 months
- •Conventional desensitization in past 3 months
结局指标
主要结局
Serum Interleukin 10 and 13 level
时间窗: 1 year
次要结局
- Incidence of adverse events if any(1 year)
研究者
Dr. Shubhamoy Ghosh, MD (Hom)
Lecturer of the Department of Pathology & Microbiology
Mahesh Bhattacharyya Homoeopathic Medical College and Hospital