Efficacy of Individualised Homoeopathic Medicine versus Lac Defloratum in Centesimal scale for the Management of Migraine - A Single Blind Randomised Controlled Trial.
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
- The Migraine Disability Assessment (MIDAS) questionnaire
研究概览
简要总结
Migraine is a common neurological disorder characterized by recurrent episodes of moderate to severe headache, often accompanied by nausea, vomiting, photophobia, and phonophobia. It significantly impairs quality of life and productivity. Homoeopathy, being a holistic and individualised system of medicine, offers a non-invasive approach aimed at reducing both the intensity and frequency of migraine episodes.
This single-blind randomized controlled trial will be conducted at Nehru Homoeopathic Medical College and Hospital, New Delhi, to evaluate the comparative efficacy of Individualised homoeopathic medicines versus Lac Defloratum in migraine management. Sixty participants between 20–60 years of age, fulfilling the International Headache Society (ICHD-3) diagnostic criteria, will be recruited through purposive sampling. After informed consent, participants will be randomly allocated into two arms (30 each):
Experimental arm: Individualised homoeopathic medicines prescribed on the basis of case taking, repertorisation, and totality of symptoms.
Comparator arm: Lac Defloratum prescribed in suitable potency according to case requirement.
Medicines will be administered orally in centesimal potencies. Potency and repetition will be individualised based on susceptibility, severity, and clinical response. Follow-ups will be conducted every 2 weeks or depending upon the need of the case. The primary outcome is to compare the efficacy of individualized homoeopathic medicine and Lac Defloratum in reducing migraine frequency, intensity, and duration. The secondary outcome is to assess improvement in quality of life using the Migraine Disability Assessment Scale (MIDAS) before and after treatment.
All data will be collected using standardized case proformas, and confidentiality will be maintained. Pharmacovigilance will be ensured, with any adverse events documented and managed appropriately. Statistical analysis will be applied to evaluate outcomes. This study aims to generate reliable comparative data on individualised homoeopathic medicines versus Lac Defloratum, thereby addressing existing research gaps and contributing to evidence-based homoeopathic management of migraine.
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
- 20.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Individuals aged between 20 and 60 years, of various socioeconomic background, shall be considered eligible for inclusion in the study.
- •2.Participants of all genders will be enrolled in the trial.
- •3.Those cases fulfilling the International Headache Society, diagnostic criteria for migraine.
- •4.Patient giving written consent form.
排除标准
- •1.Individuals with a diagnosed psychiatric disorder.
- •2.Pregnant and lactating individuals.
- •3.Patients diagnosed with any form of malignancy.
- •4.Individuals who are immunocompromised.
- •5.Patients requiring emergency medical intervention at the time of recruitment.
- •6.Individuals with uncontrolled systemic hypertension.
结局指标
主要结局
The Migraine Disability Assessment (MIDAS) questionnaire
时间窗: At Baseline and after 4 months of Treatment
次要结局
未报告次要终点
研究者
Dr Mehr Singh
Nehru Homoeopathic Medical College and Hospital