Efficacy of Individualized Homoeopathy in the Treatment of Moderate to Severe Allergic Rhinitis in Comparison with Allopathy: A Multicentric, Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 144
- 试验地点
- 3
- 主要终点
- Changes in TNSS (Total Nasal Symptom Score)
研究概览
简要总结
The study is intended to evaluate the efficacy of individualized homoeopathic treatment compared with Allopathy in treating moderate to severe Allergic rhinitis over one year follow-up period. Further, the study also intends to evaluate the role of homoeopathic organopathic remedies like Allium cepa, Ambrosia artimisiaefolia, Aralia racemosa, Arum triphyllum, Arundo mauritanica, Euphrasia officinalis, Kali iod, Naphthalinum, Pollantinum, Sabadilla, Sanguinaria nigra, Sinapis nigra, Skookum-chuk and Sticta pulmonaria in the management of acute exacerbations of Allergic rhinitis in the homoeopathic arm. For analysis of the data, the intention-to-treat population is considered. The primary outcome parameters, TNSS, and RCAT scores will be analyzed using the Kruskal Wallis H Test. Other appropriate statistical tools will be used to analyze other variables.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with a history of an allergic cause and one or more of the following symptoms: episodic rhinorrhoea, sneezing, obstruction of the nasal passages with lachrymation, post-nasal discharge, and pruritus of the nasal mucosa, conjunctiva and oropharynx together with the anterior rhinoscopic findings of pinkish grey pale, boggy mucosa covered with a thin glistening mucous and hypertrophied turbinates.
- •Presence of moderate to severe symptoms as per ARIA classification and TNSS.
- •Voluntary written informed consent.
排除标准
- •Patients who are not adequately symptomatic (Mild cases as per ARIA classification and TNSS) or have rhinoscopic findings not consistent with the diagnosis of AR Patients with serious illnesses (known cases of severe renal or hepatic diseases, malignancy, etc.) Patients under any medication for the symptoms of Allergic rhinitis in the past 15 days Cases with other causes of chronic rhinitis or complications of AR like nasal polyposis, bacterial sinusitis, etc., Patients with significant psychological diseases Pregnancy and lactation Patients not ready to give informed consent.
结局指标
主要结局
Changes in TNSS (Total Nasal Symptom Score)
时间窗: At Baseline and every 3 months
Changes in RCAT (Rhinitis Control Assessment Test)
时间窗: At Baseline and every 3 months
次要结局
- Improvement in the quality of life of the patient through RQLQ(Changes in rhinoscopy and AEC.)