Homoeopathic Drug Proving of Drug Code 161: A Multicentre, double blind, randomized placebo controlled trial.
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 45
- 试验地点
- 9
- 主要终点
- The pathogenesis of this drug substance 161
研究概览
简要总结
The study is a double blindrandomized placebo control clinical trial to see the pathogenetic effect of theinvestigational drug substance on healthy volunteers. The drug has to be provedin ascending potencies. The drug is administered after PME and 1-2 weeksrun-in-period. The provers are advised to take 4 doses in a day (4 hourly)for 3days from the prescribed batch (potency) of the coded drug. After thecompletion of the batch(potency), one month washout period will be maintainedin all provers, before the next batch (potency) is initiated. After finishingall the batches (potencies), the provers will undergo Post Trial MedicalExamination. The codes will be broken after the completion of the study anddata will be compiled to know the pathogenesis of this drug substance and analysedto find characteristic symptom (prescribing indication). The proving symptomswill be identified and segregated from the symptoms produced in placebo group.The proving symptoms will from the drug pathogenesis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Age : 18 – 60 years.
- •Both males and females.
- •Healthy individuals with no apparent disease and normal routine laboratory parameters during screening.
- •Intelligent enough to record carefully the facts, subjective and objective symptoms generated by the drug during proving.
- •Able to be informed of the nature of the study and willing to give written informed consent.
排除标准
- •Any disease or condition which might compromise the hematopoietic, renal, endocrine, pulmonary, central nervous system, cardiovascular, immunological, dermatological, gastro-intestinal or any other body system.
- •Persons with colour blindness.
- •Persons who have undergone surgery in last two months.
- •Planned medical / dental treatment during the proving period including herbal or dietary supplements, procedures, or medications that are likely to interfere with, or substantially alter, responsiveness to the proving substance.
- •Volunteers on regular medication (allopathic, ayurvedic, homoeopathic, naturopathic, unani, etc.) for any acute or chronic disease.
- •Participant must not be on any homoeopathic remedy in the preceding one month and have had no significant change in health status in last one month.
- •Emotionally disturbed, hysterical or anxious persons.
- •Persons having known history of allergies, food hypersensitivity, etc.
- •Women during pregnancy, puerperium and while breast-feeding and women who have undergone hysterectomy.
- •Smokers who smoke more than 10 cigarettes per day.
- •Recent history of alcoholism / drug addictions or unlikely to refrain from excessive alcohol consumption / drug intake during the study period.
- •Participation in another clinical or proving trial during the last 6 months.
结局指标
主要结局
The pathogenesis of this drug substance 161
时间窗: Approximately 1 year
次要结局
未报告次要终点