Effectiveness of Galphimia Glauca and Individualized Homoeopathic Medicines in Allergic Rhinitis: A Prospective Open Label Randomized Control Trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- To compare the effects of 12 weeks treatment with Galphimia Glauca and Individualized Homoeopathic Medicine on Total Nasal Symptom Score in patients of the age group of 18-50 years with allergic rhinitis
研究概览
简要总结
Allergic rhinitis (AR) is an IgE mediated immune response towards an inhaled allergen producing symptoms like sneezing, nasal congestion, running nose and nasal pruritis with ocular symptoms like itchy watery eyes and redness of eyes. The most common allergens include hay and dust,mold spores, seasonal pollens and animal hairs.Today, allergic rhinitis poses a major health concern to over 60 million people in Europe and over 400 million people globally.This increased incidence and prevalence of allergic rhinitis will impair the individual’s quality of life, reduce the performance at work and affect the psychological wellbeing and cognitive function.The conventional system of medicines mainly uses antihistamines for allergic rhinitis. But the
pharmacological studies show that the first generation antihistamines are less effective and also they have unwanted side effects on central nervous system causing sedation, performance deficit on memory, intelligence, vigilance and speed. Homoeopathy is found to be very effective in the treatment of allergic rhinitis. Studies show that homoeopathic medicines are superior in their action than placebo. Homoeopathy is based on the principle similia similibus curenter, that is medicines are selected based on individualization and the remedies selected based on this work very well. Dictionary of homoeopathic materia medica- 131 new Homoeotherapeutics by Dr O.A Julian shows that Galphimia glauca has herbal uses for a whole variety of allergic infections, also it shows that galphimia is effective for hay fever, vasomotor allergic rhinopathies and hypersecretion of the nasal mucus and ocular mucus, sneezing and hypersensitiveness to the change of weather in its pathogenesis. Homoeopathic remedy Galphimia glauca is found to be effective in the symptomatic treatment of allergic rhinitis and is superior than placebo without any adverse effects. Also effects of Galphimia glauca are comparable to those of antihistamines or other antiallergic agents as well. A randomised prospective study by Ernest shows that homoeopathic Galphimia glauca has effects of similar magnitude as conventional antihistamines, though no comparative studies have tested this hypothesis. Studies and homoeopathic literature show that Galphimia glauca is found to be effective in the treatment of allergic rhinitis with no adverse effects(10). But no relevant studies are conducted on the effectiveness of Galphimia glauca on allergic rhinitis since 1997. Also no intention to treat analyses (ITT) were reported in any of the randomized control trials. Also no validated outcome measures are used in most of the studies.So my effort is aimed to compare the effectiveness of Galphimia glauca with individualized homoeopathic medicines in allergic rhinitis using a validated outcome measure (TNSS- Total Nasal Symptom Score).
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, fixed
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)(—)
- 性别
- All
入选标准
- •Individuals meeting case definition of allergic rhinitis Patients in the age group of 18-50.
排除标准
- •Patients with symptoms of asthma Individuals with serious life threatening illness like cardiac complaints and renal failure Pregnant and lactating mother Patients taking antihistamines or having received antihistamine therapy or corticosteroids in past two weeks.
结局指标
主要结局
To compare the effects of 12 weeks treatment with Galphimia Glauca and Individualized Homoeopathic Medicine on Total Nasal Symptom Score in patients of the age group of 18-50 years with allergic rhinitis
时间窗: To compare the effects of 12 weeks treatment with Galphimia Glauca and Individualized Homoeopathic Medicine on Total Nasal Symptom Score in patients of the age group of 18-50 years with allergic rhinitis
次要结局
- To compare the effects of 12 weeks treatment with Galphimia Glauca and Individualized Homoeopathic Medicine on serum IgE in patients of the age group of 18-50 years with allergic rhinitis.(To compare the effects of 12 weeks treatment with Galphimia Glauca and Individualized Homoeopathic Medicine on Total Ocular Symptom Score in patients of the age group of 18-50 years with allergic rhinitis.)
