Effectiveness of Individualised Homoeopathic Medicines Selected Using Allens Encyclopedia of Pure Materia Medica in the Management of Bronchial Asthma: A Prospective, Open-Label, Single-Arm Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- proportion of patients showing a clinically significant
研究概览
简要总结
This prospective, open-label, single-arm clinical trial will be conducted at Nehru Homoeopathic Medical College and Hospital, New Delhi, to evaluate the effectiveness of individualised homoeopathic medicines in the management of bronchial asthma. A total of 40 patients aged 17–70 years with a confirmed diagnosis of bronchial asthma will be recruited based on predefined inclusion and exclusion criteria. Written informed consent will be obtained before enrolment. Patients will undergo detailed case taking, repertorization using Synthesis repertory (RADAR software), and final remedy confirmation from Allen’s Encyclopedia of Pure Materia Medica. Medicines will be dispensed free of cost from GMP-certified pharmacies in commonly used potencies (30C, 200C, 1M) in medicated globule form. The intervention will be provided alongside patients’ existing conventional treatment, and follow-up will be scheduled fortnightly. Data will be collected at baseline and monthly intervals using validated tools, including the Asthma Control Test (ACT), spirometry, and the standardized Asthma Quality of Life Questionnaire (AQLQ(S)). The primary outcome will be the proportion of patients showing a clinically significant improvement in ACT scores (more than or equal to 3 points). Secondary outcomes include improvement in quality of life and documentation of the spectrum of prescribed medicines. Statistical analysis will include descriptive statistics, paired t-test/Wilcoxon signed-rank test, McNemar’s test, and exact binomial test, with significance set at p<0.05. Both intention-to-treat and per-protocol analyses will be performed, and missing data will be managed using last observation carried forward. Ethical clearance has been obtained, pharmacovigilance will be ensured, and CTR-I registration will be completed prior to study initiation. Participation is voluntary, and confidentiality will be maintained.
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
- 17.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients presenting with clinical signs & symptoms consistent with bronchial asthma, after confirming the diagnosis with Lung Function Tests (spirometry).
- •Patients with a confirmed diagnosis of bronchial asthma by a qualified medical practitioner (based on clinical history and/or diagnostic tests).
- •Patients aged between 17 to 70 years irrespective of their gender.
- •Patients on conventional treatment for bronchial asthma.
- •Patients who are willing to participate and provide written informed consent.
排除标准
- •Participants meeting any of the following criteria will be excluded from the study:
- •Patients diagnosed with severe persistent asthma with significant restriction of daily activities.
- •Patients experiencing status asthmaticus.
- •Patients with serious complications or uncontrolled/life-threatening systemic illnesses (e.g., cardiac failure, uncontrolled diabetes, renal or hepatic failure).
- •Patients diagnosed with any psychiatric illness that may interfere with compliance or assessment.
- •Pregnant women and lactating mothers.
- •Individuals with a history of substance abuse or dependence.
- •Patients unwilling or unable to provide informed consent or participate in the study procedures.
结局指标
主要结局
proportion of patients showing a clinically significant
时间窗: ACT will be estimated at baseline & at every 4 week interval. Final assessment will be done after 6 months of enrolment.
improvement in ACT scores
时间窗: ACT will be estimated at baseline & at every 4 week interval. Final assessment will be done after 6 months of enrolment.
次要结局
- improvement in quality of life using AQLQ(S) & documentation of the spectrum of prescribed medicines(AQLQ(S) scores will be estimated at baseline & at every 4 weeks. Final assessment will be done after 6 months of enrolment.)
研究者
Dr Vivek Kumar
Nehru Homoeopathic Medical College and Hospital