跳至主要内容
临床试验/CTRI/2024/12/077756
CTRI/2024/12/077756招募中不适用

Role of individualized homoeopathic medicines in the treatment of Parkinsons disease in elderly: A single-arm, quasi-experimental study

D N De Homoeopathic Medical College and Hospital1 个研究点 分布在 1 个国家目标入组 34 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
34
试验地点
1
主要终点
Scales for Outcomes in parkinsons Disease Motor Function (SCOPA-Motor)

研究概览

简要总结

Parkinson’s disease (PD) is a complex, progressive, chronic neurodegenerative disorder of elderly people described by English physician James Parkinson in 1817. Reflecting the unique symptoms of his patients, the name Parkinson’s disease “ was adopted and used by the public ever since approximately 10 million people. The primary basis for the clinical diagnosis of PD is motor characteristics like cogwheel rigidity a slowly progressing asymmetric resting tremor inflexibility, and bradykinesia, even though nonmotor highlights which incorporate anosmia, depression, insomnia, cognitive impairment, dementia, sensory disturbances, and rapid eye movement sleep behaviour disorder are all possible conditions. Numerous medicines and surgical resources are not available, accessible, or reasonable all over especially in low and middle-income countries. However, the effectiveness of the treatment is still controversial. Evidence of homoeopathic experience in the treatment of the symptoms of PD, i.e. Bradykinesia, rigidity, and tremors are already clearly documented in homoeopathic literature in the form of Repertoires and Materia Medica. A single-arm quasi-experimental study will be conducted at D N De Homoeopathic Medical College and Hospotal on 34 patients with parkinson’s disease and all will be treated with individualized homeopathic medicines for 3 months. The primary outcome is SCOPA-motor; the secondary outcomes comprise of PDQ-8 and MYMOP-2; all measured at baseline and every month, up to 3 months. Changes will be determined using inferential statistics. Results will be published in scientific journals.

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
60.00 Year(s) 至 75.00 Year(s)(—)
性别
All

入选标准

  • Patients suffering from PD with symptoms the presence of Bradykinesia and at least one other feature of parkinsonism viz.
  • rigidity, tremors, or impaired balance.
  • (ICD 10 code G20)
  • Elderly people of 60 to 75 years.
  • Patients of both sex.

排除标准

  • Denying written informed consent voluntarily.
  • Vulnerable population: Unconscious, non-ambulatory, too sick for consultation, differently abled, terminally ill or critically ill patients, and mentally incompetent people.
  • Diagnosed cases of unstable mental or psychiatric illness or other uncontrolled diabetes or life-threatening illness affecting the quality of life or any organ failure.
  • Patient under tobacco chewing and/or smoking, alcoholism, and/or any other form(s) of substance abuse and/or dependence (TAPS tool).
  • Self-reported immune-compromised state.
  • Already undergoing homeopathic treatment for chronic disease or any other mode of treatment for PD within the last 6 months.
  • simultaneous participation in any other clinical trials.

结局指标

主要结局

Scales for Outcomes in parkinsons Disease Motor Function (SCOPA-Motor)

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

次要结局

  • Parkinsons Disease Quality of Life Questionnaire (PDQ-8)(Baseline, every month, up to 3 months)
  • Measure Yourself Medical Outcome Profile, version 2 (MYMOP-2) questionnaire(Baseline, every month, up to 3 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

Md Yasin Biswas

D. N. DE HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL

研究点 (1)

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