Efficacy of Individualized Homoeopathic medicines in Persistent and Perennial Allergic Rhinitis: Double Blind, Randomized, Placebo-Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- To evaluate the efficacy of individualized homoeopathic medicine in comparison with placebo in treatment of persistent and perennial allergic rhinitis.
研究概览
简要总结
The study titled “Efficacy of Individualized Homoeopathic Medicines in Persistent and Perennial Allergic Rhinitis” is a double-blind, randomized, placebo-controlled clinical trial conducted at NHMC, Lucknow. It aims to evaluate the effectiveness of individualized homoeopathic medicines compared to placebo in improving symptoms and quality of life among patients with persistent and perennial allergic rhinitis. A total of 140 participants, aged between 18 and 65 years, were enrolled according to specific inclusion and exclusion criteria and randomly assigned to two parallel groups — experimental (individualized homoeopathic medicines in centesimal potencies) and control (indistinguishable placebo) groups.
Randomization was carried out using a computer-generated random number chart, ensuring equal allocation and minimizing selection bias. Both the participants and investigators were blinded to the treatment assignment to maintain the integrity of the trial. Participants were followed for three months, during which both subjective and objective outcomes were recorded and were regularly followed up to monitor symptom changes and treatment responses. The primary outcome was assessed using the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ), while secondary outcomes included Visual Analogue Scale (VAS) scores for nasal and non-nasal symptoms, along with overall quality-of-life assessment. Ethical approval, informed consent, and prospective trial registration were obtained. The study design ensures methodological rigor and aims to determine whether individualized homoeopathic treatment offers a statistically significant advantage over placebo in managing allergic rhinitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator 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
- •Cases suffering from Allergic Rhinitis persistent and perennial variety and of moderate intensity for more than 1 year.
- •Atopic: reactive to inhaled allergens
- •Literate patients: can read hindi or/and english
- •Providing written informed consent to participate in the trial.
排除标准
- •1.Nasal abnormalities causing obstruction, e.g. nasal polyp and deviated nasal septum.
- •2.Allergen avoidance in the past 6 weeks.
- •3.Away from usual environment for more than 1 week during the trial.
- •4.Respiratory infections.
- •5.Patients at risk of developing bronchial asthma.
- •6.Other uncontrolled or unstable systemic or psychiatric diseases and/or infections affecting quality of life.
- •7.Patients who are too sick for consultation.
- •8.Unwilling to take part and not giving consent to join the study.
- •9.Unable to read the patient information sheet.
- •11.Substance abuse and/or dependence.
- •12.Self-reported immunocompromised state.
- •13.Use of oral or parenteral steroids in the past 6 months.
- •14.Conventional desensitization in the past 6 months.
- •15.Previous homeopathic immunotherapy for perennial allergic rhinitis.
- •16.Undergoing homeopathic treatment for any chronic disease within the last 6 months.
结局指标
主要结局
To evaluate the efficacy of individualized homoeopathic medicine in comparison with placebo in treatment of persistent and perennial allergic rhinitis.
时间窗: 3 months
次要结局
- 1. to detect the group differences in RQLQ and VAS measures of nasal, non-nasal and and global severity and QOL over 3 months.(2. To shortlist the most frequently indicated homoeopathic medicines in the treatment of allergic rhinitis.)
研究者
Dr Reshma Chandrabhanji Hiwrale
State National Homoeopathic medical College and hospital, Gomtinagar lucknow