跳至主要内容
临床试验/CTRI/2024/03/064438
CTRI/2024/03/064438招募中3 期

Efficacy of individualized homoeopathic medicines in LM potencies in reducing cancer-related fatigue: A series of n-of-1 trials

D. N. De Homoeopathic Medical College and Hospital1 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2024年4月1日最近更新:

试验速览

阶段
3 期
状态
招募中
发起方
入组人数
21
试验地点
1
主要终点
The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)

研究概览

简要总结

Cancer-related fatigue (CRF) is defined as a “distressing, persistent, subjective sense of physical, emotional, and/or cognitive tiredness or exhaustion, related to cancer or cancer treatment, that is not proportional to recent activity and interferes with usual functioning.” This fatigue is considered to be multidimensional in nature, and a hallmark feature is that CRF is not generally relieved by rest.  CRF may result from the disease itself or from treatments, and it often worsens during the acute treatment timeframe. Estimates of the prevalence of CRF range from 25% to 99%, depending on the type and stage of cancer, type of treatment received. CRF is associated with significant physical and psychological impairments and a decrease in overall quality of life during and after cancer treatment. Homoeopathy may have immense potential to offer in the successful treatment of CRF, but it has remained seriously under-researched till date. Under such circumstances, we intend to undertake this research project to evaluate the efficacy and safety of individualized homoeopathic medicines (IHMs) in the treatment of CRF in adults. A series of double-blind, randomized, placebo-controlled n-of-1 trials will be conducted on 21 adults who are suffering from CRF at the outpatient’s department of D. N. De. Homoeopathic Medical College and Hospital. Assessment will be done by the Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) score (primary outcome), the Short Form 36 (SF-36) Health Survey Questionnaire, and the Wu Cancer Fatigue Scale (WCFS) score (secondary outcome) every 20 days up to 2 months. Comparative analysis will be carried out to detect group differences. The 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 cancer-related fatigue (ICD-10 code R53.0) for at least 3 months
  • Patients who screen positively for fatigue (values of 4 out of 10 or higher indicating moderate to severe fatigue)
  • Age between 18 and 75 years
  • Either sex or transgender.

排除标准

  • Patients who are not willing to cooperate and are 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 illnesses, or other uncontrolled or life-threatening illness affecting quality of life or any organ failure
  • Patients with psychiatric disorders
  • Undergoing homoeopathic treatment for chronic disease within last 6 months
  • Substance abuse and/or dependence
  • Pregnant, puerperal and lactating women
  • Simultaneous participation in any other clinical trial.

结局指标

主要结局

The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)

时间窗: Every 20 days, up to 2 months

次要结局

  • The Short Form 36 (SF-36) Health Survey Questionnaire(Every 20 days, up to 2 months)
  • The Wu Cancer Fatigue Scale (WCFS)(Every 20 days, up to 2 months)

研究者

发起方
D. N. De Homoeopathic Medical College and Hospital
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Mahejabeen Siddique

D. N. De Homoeopathic Medical College and Hospital

研究点 (1)

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