A Single-Arm Clinical Study to Evaluate the Effectiveness of Individualised Homoeopathic Treatment in Cases of Allergic Rhinitis using Boenninghausen’s Characteristics & Repertory by C.M. Boger
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
研究概览
简要总结
Allergic rhinitis (AR) is a chronic IgE-mediated inflammatory condition of the nasal mucosa caused by hypersensitivity to environmental allergens such as pollen, dust mites, molds, and animal dander. It is characterized by symptoms including sneezing, nasal obstruction, rhinorrhea, and nasal itching, which can significantly impair the quality of life of affected individuals. The diagnosis is primarily based on clinical history, characteristic symptoms, and clinical examination while excluding other causes of chronic rhinitis.
Homoeopathy follows an individualized approach to treatment based on the totality of symptoms of the patient. Repertorization plays a crucial role in remedy selection, and Boenninghausen’s Characteristics and Repertory revised by C.M. Boger is one of the classical repertories used for systematic analysis of symptoms in homoeopathic practice. However, scientific evidence evaluating the effectiveness of individualized homoeopathic treatment using this repertory in allergic rhinitis remains limited.
The present study is designed as a prospective, open-label, single-arm clinical study to evaluate the effectiveness of individualized homoeopathic treatment in cases of allergic rhinitis. The study will be conducted at the OPD of the National Institute of Homoeopathy, Narela, Delhi. After explaining the details of the study in the participant’s own language, written informed consent will be obtained from all eligible participants. Detailed case taking will be carried out according to homoeopathic principles, and remedies will be selected through repertorization using Boenninghausen’s Characteristics and Repertory by C.M. Boger.
A total of 40 patients fulfilling the inclusion criteria will be enrolled through consecutive sampling and will receive individualized homoeopathic medicines based on the totality of symptoms. Each participant will be followed up periodically for a duration of three months.
The change in individual nasal symptoms and overall symptom severity will be assessed using the Total Nasal Symptom Score (TNSS) at baseline and after treatment. Reduction in the frequency of use of antihistamines during the study period will also be recorded. Any adverse drug reactions, if observed, will be documented and reported through the AYUSH Suraksha Portal as per pharmacovigilance guidelines. The causal attribution between the intervention and clinical outcome in improved cases will be assessed using the Modified Naranjo Criteria for Homeopathy (MONARCH).
The collected data will be analyzed using appropriate statistical methods to evaluate the effectiveness of individualized homoeopathic treatment in patients with allergic rhinitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients clinically diagnosed with Allergic Rhinitis, presenting with characteristic symptoms such as sneezing, nasal obstruction, rhinorrhoea, and nasal itching.
- •2.Patients of either sex aged between 18–60 years.
- •3.Cases meeting the ARIA classification for Allergic rhinitis.
- •4.Patients having a baseline TNSS between 5 and
- •5.Participants must be able to give informed consent, meaning they understand the nature of the study or treatment and agree to participate voluntarily.
排除标准
- •1.Pregnant or lactating women.
- •2.Patients with severe systemic illnesses such as uncontrolled diabetes, cardiovascular disorders, chronic kidney disease, or hepatic impairment.
- •3.Patients with other chronic respiratory conditions such as asthma, chronic sinusitis, rhinosporidiosis or COPD that may confound the assessment of allergic rhinitis.
- •4.Patients currently receiving systemic treatments such as corticosteroids or immunotherapy, or undergoing treatment for allergic rhinitis under other systems of medicine including Ayurvedic, Unani, Siddha, or other alternative therapies, and unwilling to discontinue them during the study period.
- •Patients already enrolled or registered in another clinical study during the study period.
研究者
Dr Sahiba Sadaf
National Institute of Homoeopathy, Delhi