Effectiveness of individualized homoeopathic medicine as a discrete or as an adjuvant in the treatment of allergic bronchial asthma evaluated by serum Immunoglobulin E levels and spirometry measurements A double arm prospective nonrandomized clinical study
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Primary outcome: Spirometry at base line and 6 months
研究概览
简要总结
RESEARCH QUESTION: Is individualized homoeopathic medicine, as a discrete or as an adjuvant, effective in treatment of allergic bronchial asthma evaluated based on serum IgE and spirometry measurements?
HYPOTHESIS: Null hypothesis (H0): There is no significant change in IgE levels and spirometry measurements among patients suffering from allergic bronchial asthma following the individualized homoeopathic medicine as a discrete or as an adjuvant treatment. Alternative hypothesis (HA): There is significant change in serum IgE levels and spirometry measurements among patients suffering from allergic bronchial asthma following the individualized homoeopathic treatment as a discrete or as an adjuvant treatment.
AIM: To assess the effectiveness of individualized homoeopathic medicines as a discrete or as an adjuvant in patients with allergic bronchial asthma.
OBJECTIVES:
- To assess the changes in serum IgE levels as well as spirometry in patients suffering from allergic bronchial asthma following the individualized homoeopathic medicine as a discrete or as an adjuvant treatment.
- To assess the changes in asthma control test (ACT) score in patients suffering from allergic bronchial asthma following the individualized homoeopathic medicine as an adjuvant treatment.
The serum IgE levels, a blood parameter, spirometry levels, and the ACT score data will be collected once at baseline and at 6 months duration following treatment which will be assessed in specially designed Microsoft Office Excel spread sheet (master chart) for data extraction and statistical analysis. All cases will be recorded in a standard case taking proforma. Data of the cases will be obtained from the patient attendants, and physician’s own observations. Professional etiquette and ethics will be maintained at utmost level.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 12.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients who are having signs and symptoms of allergic asthma.
- •Patients having increased IgE levels.
- •Patients with reduction in FEV1/ FVC ratio.
- •Patients of age 12 to 40 years of age, irrespective of their gender, race, religion and socio- economic status Willingness and ability to comply with scheduled visits, treatment plans and other study procedures.
- •Patient must be capable of giving informed consent.
- •Patient will have option to decide whether to take homoeopathic medicine along with the conventional treatment or to use homoeopathy as discrete mode of treatment.
- •Both the type of patient will be included in the study as two different arm of study.
排除标准
- •Patients who are diagnosed with an unstable mental or psychiatric illness or other uncontrolled or life-threatening diseases including organ failure that affect the quality of life Patient suffering from status asthmaticus Pregnant or lactating women Patients on substance abuse.
结局指标
主要结局
Primary outcome: Spirometry at base line and 6 months
时间窗: Primary outcome: Spirometry at base line and 6 months
次要结局
- IgE levels and ACT SCORE at baseline and 6months(baseline and 6 months)
研究者
Dr Deepshika Sharma
National Institute of Homoeopathy