Randomised Placebo Control and Parallel Arm Trial to assess the Effectiveness of Histaminum hydrochloricum in Ascending LM potency on Management of Allergic rhinitis
试验速览
- 阶段
- Phase 3 4
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Study is expected to show reduction in symptoms and recurrence of the allergic rhinitis in patients under Histaminum Hydrochloricum than control group
研究概览
简要总结
Histaminum hydrochloricum is a potent medicine that can offer near antihistaminic effect. The effect of Histaminum on basophils have been explored through various invitro studies and found that Histaminum have significant inhibitory effect on basophil activation. However, there is no adequate clinical research done and published on the clinical effectiveness of Histaminum on the same even though Histaminum is suitable in many of the cases with atopic background. Conditions like allergic rhinitis are having a severe acute phase so immediate and frequent administration of medicines are needed to management of condition effectively. To achieve this without aggravation 50 millesimal potency is used throughout the study. Hence this research aims on the clinical applicability of Histaminum hydrochloricum in LM potency in cases of allergic rhinitis.
Patients are chosen in to the study on the basis of inclusion and exclusion criteria .Patients suiting the totality of Histaminum hydrochloricum is taken in to the study and is randomly divided in to control and interventional group.20 cases are randomly classified as control group and 20 cases as interventional group. Control group is administered with placebo and nasal saline.
Other 20 cases are selected as the interventional group administered with Histaminum hydrochloricum in ascending LM potency as per the requirement of the patient. Histaminum hydrochloricum starting with 0/1 potency followed by successive higher potencies. Medicine is repeated as per the requirement of the case. Pre and post assessment of serum IgE, AEC is done in all the patients. Assessment of the patient is done using total nasal symptom scoring and rhinitis control assessment test. Medicine is repeated on a weekly basis and follow up is done every week.
Post assessment of IgE AEC is done within 6 months and score assessment is done once in a month. Statistical analysis is done using paired t test.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 5.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient clinically diagnosed with allergic rhinitis.
- •Patients having elevated serum IgE levels above 200 Iu/ml Age limit 5 to 50 years Both genders are included.
排除标准
- •Patients with only DNS, nasal polyp associated rhinitis is excluded.
- •Patients with serious extended chest infections are excluded.
- •Patients having other IgE mediated hypersensitivity reactions like urticaria, atopic dermatitis.
结局指标
主要结局
Study is expected to show reduction in symptoms and recurrence of the allergic rhinitis in patients under Histaminum Hydrochloricum than control group
时间窗: 6 months
Lowering of serum IgE and AEC levels in group under homoeopathic medication
时间窗: 6 months
次要结局
- Improvement in quality of life of the patient(6 months)
研究者
Dr AMALA M
Sarada krishna Homoeopathic Medical College