A Randomised double arm parallel clinical study to compare effectiveness of Individualised homoeopathic medicine versus Histaminum in the management of allergic rhinitis
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Total symptoms score
研究概览
简要总结
The study will be a Prospective, Double arm parallel group, open label, randomized clinical study to assess the effectiveness of individualized homoeopathic medicine in the treatment of allergic rhinitis.
Patients will be randomly allocated in 1:1 ratio by using computerized Block Randomization into 2 groups: individualized homoeopathic medicine treatment group and HISTAMINUM treatment group.
Hypothesis depends upon any significant difference between the two comparable groups i.e. Group A is Individualized homoeopathic Medicine and Group B is Histaminum in treatment of Allergic Rhinitis.
Final evaluation of results will be assessed on the basis of improvement in symptoms as well as by using TSS Score.
Follow up of cases will be depending upon the severity of the symptoms, and as per the need and the necessity of the case preferably fortnightly.
Study duration is one year, 60 patients are included in the study patients are followed every 2 weeks (next 4 weeks) up to 6 months the outcomes are measured every 4 weeks up to 24 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 10.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients having clinical signs and symptoms of Allergic Rhinitis as per ICD 10 classification J30.411 Pre diagnosed cases of Allergic Rhinitis.
- •Patients who have not taken any treatment since last 1 week for Allergic Rhinitis .
排除标准
- •Patients with serious complications and other uncontrolled or life-threatening systemic illness.
- •Case of Nasal Polyp ,Deviated Nasal Septum ,Sinusitis, Allergic Bronchitis , Asthma or other Respiratory illness resembling allergic rhinitis Diagnosed cases of Psychiatric illness.
- •Pregnant women and Lactating mothers.
- •Substance abuse/ Dependence.
- •Patients who are not willing to be a part of this study.
- •Self-reported Immunocompromised state.
结局指标
主要结局
Total symptoms score
时间窗: 2 WEEKS
次要结局
- TOTAL SYMPTOM SCORE(1 month)
研究者
DR Subhi Jain
Nehru Homoeopathic Medical College and Hospital