跳至主要内容
临床试验/CTRI/2024/12/077618
CTRI/2024/12/077618招募中不适用

Efficacy of individualized homoeopathic medicines in the treatment of fibromyalgia in adults: A double-blind, randomized, placebo-controlled trial

D.N.De Homoeopathic Medical college1 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2024年12月16日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
54
试验地点
1
主要终点
The Revised Fibromyalgia Impact Questionnaire (FIQR)

研究概览

简要总结

Fibromyalgia is a chronic pain syndrome characterized by widespread pain, sometimes with accompanying symptoms such as persistent tiredness and disturbed sleep. Globally, fibromyalgia prevalence varies: it can be found in the general population between 0.2 and 6.6%, in women between 2.4 and 6.8%, in urban areas between 0.7 and 11.4%, and in rural areas between 0.1 and 5.2%. An Indian study found a frequency of 0.05 in this range .Traditional fibromyalgia treatments frequently involve physical therapy and painkillers. However, there’s a chance that these therapies have unintended adverse effects and don’t always offer long-term relief were noteworthy findings supporting homoeopathy, most of which showed promising outcomes, It may have enormous promise for fibromyalgia symptom relief; However, due to methodological issues and a dearth of trials, the symptomatic treatment of IHMs was poorly studied. Under such circumstances, we intend to undertake this research project to evaluate the efficacy of IHMs in the symptom management in adults. A double-blind, randomized (2:1), placebo-controlled trial will be conducted on 54 adults who are suffering from fibromyalgia at the outpatient’s department of D. N. De Homoeopathic Medical College and Hospital. The primary outcome measure is FIQR Score ;the secondary outcomes are PROM-FM and MYMOP 2  questionnaires, all are measured at baseline and every month up to 3 months. Comparative analysis will be carried out to detect group differences. Result 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 65.00 Year(s)(—)
性别
All

入选标准

  • 1.Patients who have received a diagnosis of primary fibromyalgia according to The American College of Rheumatology 2010 criteria for the classification of fibromyalgia â–ª Widespread pain score 7 or more â–ª Based on severity of symptom (SS 5 or more)
  • Age between 18 and 65 years
  • Symptoms are present for at least 3 months.
  • Participants of either sex or transgender.
  • Patients ability to understand English / Hindi / Bengali.

排除标准

  • 1.Not providing with written informed consent of participation.
  • Participants despite meeting the ACR 2010 fibromyalgia criteria , having PDS / FM Scale (WPI+SS), None (0-3) , Mild (4–7) , Moderate (8-11), Very severe (20–31)
  • A current diagnosis of infection or Musculoskeletal inflammatory conditions
  • Non-ambulant patients.
  • Self-reported conditions other than fibromyalgia.
  • Patients who are too sick for consultation.
  • Diagnosed cases of unstable mental or psychiatric illness or other uncontrolled systemic or life-threatening illness affecting quality of life or any organ failure.
  • Pregnancy, puerperal women and lactating mother.
  • Tobacco chewing and/or smoking, alcoholism and/or any form(s) of substance abuse and/or dependence (TAPS tool)
  • Self-reported immune-compromised state, AIDS, hepatitis
  • Undergoing homoeopathic treatment for any chronic disease within last 3 months.

结局指标

主要结局

The Revised Fibromyalgia Impact Questionnaire (FIQR)

时间窗: Baseline, and every month, up to 3 months

次要结局

  • Multi Dimensional questionnaire for patient reported outcome measures - Fibromyalgia (PROM FM)(Baseline, and every month, up to 3 months)
  • Measure yourself Medical Outcome Profile v-2 (MYMOP-2) questionnaire(Baseline, and every month, up to 3 months)

研究者

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

Subhadra Saha

D.N.De Homoeopathic Medical College

研究点 (1)

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