Efficacy of individualized homeopathic medicines in LM potencies in addition to standard anticancer care in cancer pain management in adults A series of n of 1 trials using Synthesis Repertory
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- SF-MPQ score (Short form McGill Pain Questionnaire)
研究概览
简要总结
The International Association for the Study of Pain (IASP) defines pain as an unpleasant emotional situation which is originating from a certain area, which is dependent or non-dependent on tissue damage and which is related to the past experience of the person in question. Chronic pain is common among cancer patients, with about 40% experiencing inadequate pain management. Advances in oncology have improved pain control and increased survival rates, leading to a rise in cancer survivors. However, 27.6% of these survivors suffer from moderate to severe chronic pain, which can last over 3 to 6 months and result from various causes. Chronic pain significantly impacts quality of life, causing physical, emotional, and social challenges. Our aim to study about efficacy of individualized Homoeopathic medicines in the management of cancer pain by using a series of n-of-1 randomized, placebo-control design. Duration of study will be 2 months. Primary outcome SF-MPQ, secondary outcome EORTC- QLQ -C15- PAL, PHQ-9, measured at baseline, every 10 days up to 2 months. Results will be published in scientific journals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients suffering from pain in cancer-related pain (ICD-10 codeG89.3) for at least 3 months.
- •Aged between 18 to 75 yrs
- •Either sex or transgenders.
- •Patients ability to understand Bengali or English or Hindi.
排除标准
- •Patient has NPRS score greater than equal to 7 (severe pain)
- •Patients not willing to cooperate and not giving informed consent to participate in the trial.
- •Cases too sick for consultation.
- •Cases willing for or requiring immediate surgical intervention or undergoing major surgery in last 6 months
- •Diagnosed cases of uncontrolled systemic diseases, unstable mental or psychiatric illness or other uncontrolled or life-threatening illness affecting quality of life or any organ failure
- •Patient with psychiatric disorders
- •Undergoing homoeopathic treatment for chronic disease within last 6 months Substance abuse and/or dependence.
- •Pregnant, in puerperium and lactating women
- •Simultaneous participation in any other clinical trial.
结局指标
主要结局
SF-MPQ score (Short form McGill Pain Questionnaire)
时间窗: Baseline, every 10 days, up to 2 months
次要结局
- PHQ-9 (Patient Health Questionnaire)(Baseline, every 10 days, up to 2 months)
- EORTC QLQ-C15-PAL (European organization for research(and treatment of cancer quality of life questionnaire core 15 palliative care))
研究者
Arunabha Aditya
D N De Homoeopathic Medical College and Hospital