A RANDOMIZED CONTROLLED TRIAL TO ASSESS THE EFFECTIVENESS OF INDIVIDUALIZED HOMOEOPATHIC MEDICINES IN ACUTE PAIN
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Visual Analogue Scale (VAS) measuring pain intensity
研究概览
简要总结
Pain has been the oldest medical problem but is little understood by the physicians throughout history. Though various analgesic modalities are available, acute pain management plans must be specialized for each patient in view of individual variation. Further, people often look for
other modes of treatment such as homoeopathy that have relatively fewer or no side effects. Considering this common use of homeopathy for managing acute pain there is lack of sufficient evidence about its effectiveness, the present randomized controlled trial aimed to examine the effect of homeopathy on acute pain intensity. For the study 100 patients reporting acute pain will be enrolled. Individualized homoeopathic medicines and placebo will be prescribed. The score of pain pre and post medication will be recorded using VAS (Visual Analog Scale). Treatment outcome will be analysed using appropriate statistics.
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
- 10.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •All the patients presenting with acute pain.
- •Patients of all age group and both sexes.
- •Patients taking a prescription medication (NSAIDs, acetaminophen, and aspirin) episodically (or as needed) for the management of pain, agrees to discontinue its use prior to or at the Screening and Baseline Visit
- •Patients agreeing to not commence any new prescription medication for the management of pain throughout the study
- •Patients agreeing to not commence any injection therapy for pain during the course of the study
- •Patients agreeing to not use acupuncture, biofeedback, or transcutaneous electrical nerve stimulation (TENS) for the management of pain during the course of the study.
排除标准
- •Terminally ill patients.
- •congestive heart failure, renal failure or dialysis etc.]
- •Patients unwilling to give the consent.
- •Patients with pre-existing opiate therapy; and patients with dependencies on tobacco, alcohol, opioids, or other substances.
- •Patients with angina, bronchospasm, bronchial asthma, bronchospasm (chronic obstructive pulmonary disease and emphysema), diabetes mellitus, hyperthyroidism, fibromyalgia, or uncontrolled seizures or known hypersensitivity.
- •Anything that, in the opinion of the investigator, would place the participant at increased risk or preclude the participant’s full compliance with or completion of the study.
结局指标
主要结局
Visual Analogue Scale (VAS) measuring pain intensity
时间窗: Visual Analogue Scale (VAS) at Baseline | And After 1 week of intervention
次要结局
- Health-related quality of life (HRQOL)(Health-related quality of life (HRQOL) at Baseline & after 1 week of intervention)
研究者
ADITI CHADHA
Sri Ganganagar Homoeopathic Medical College Hospital and Research Institute