A Single-Blind Randomized Controlled Trial To Evaluate The Efficacy Of Individualized Homoeopathic Medicines Versus Ambrosia Artemisiifolia In Centesimal Scale For The Management of Allergic Rhinitis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Allergic Rhinitis Symptom Score
研究概览
简要总结
This study is a prospective, single-blind, randomized controlled trial being conducted at Nehru Homoeopathic Medical College & Hospital, New Delhi, to evaluate the efficacy of individualized homoeopathic medicines in comparison with Ambrosia artemisiifolia in centesimal potency for the management of allergic rhinitis. A total of 60 patients, aged between 18 and 65 years, clinically diagnosed with allergic rhinitis (ICD-10 J30.4), will be recruited from the outpatient department and randomly allocated in a 1:1 ratio into two groups. Group A will receive individualized homoeopathic medicines prescribed on the basis of detailed case taking and repertorization, while Group B will be given Ambrosia artemisiifolia in centesimal potency, with dosage and repetition determined by patient susceptibility and symptom severity. The study duration will be one year, including nine months for recruitment and six months for follow-up. The primary outcome measure will be the change in Allergic Rhinitis Symptom Score (ARSS), while the secondary outcome will be the change in Absolute Eosinophil Count (AEC) before and after treatment. Data will be analyzed using appropriate statistical methods with p < 0.05 considered significant, following the intention-to-treat principle. Ethical clearance has been obtained, CTRI registration is in place, and all participants will provide informed consent, with strict adherence to confidentiality and pharmacovigilance measures.
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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
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients having clinical signs and symptoms of Allergic Rhinitis as per ICD 10 classification J30.
- •2.Pre diagnosed cases of Allergic Rhinitis. 3.Patients who have not taken any treatment since last 1 week for Allergic Rhinitis . 4.Patients of
- •65 years(11). 5.Both sexes. 6.Patients willing to take homoeopathic treatment 7.Patients giving informed consent.
排除标准
- •1.Patients with known systemic illnesses.
- •2.Patients with other atopic conditions like allergic asthma, Nasal polyp, Deviated Nasal Septum and urticaria.
- •3.Age group below 18 years and above 65 years.
- •4.Patients with parasitic infections or any malignancies.
- •5.Pregnant women and Lactating mothers.
结局指标
主要结局
Allergic Rhinitis Symptom Score
时间窗: ARSS will be evaluated at baseline and at 12 weeks interval
次要结局
- Absolute Eosinophil Count(At Baseline and after 12 weeks of intervention)
研究者
Dr Parthkumar Patel
Nehru Homeopathic Medical College and Hospital