跳至主要内容
临床试验/CTRI/2025/03/082051
CTRI/2025/03/082051尚未招募不适用

Role of individualized homoeopathic medicine in 50 millesimal scale in management of ganglion cyst of hand and open single arm pre and post clinical trial

National Institute Of Homoeopathy1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年3月20日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
50
试验地点
1
主要终点
Score, Visual analogue scale (VAS) and Modified Naranjo Criteria.

研究概览

简要总结

This prospective, open-label, single-arm pre-post clinical trial will be conducted over 18 months at the National Institute of Homoeopathy, Kolkata, with each patient followed for six months. The study aims to evaluate the effectiveness of individualized homoeopathic medicine in management of ganglion cyst of hand. This study aims to assess changes in Ganglion cysts of the hand using the Patient-Rated Wrist/Hand Evaluation Score and pain levels via the Visual Analogue Scale (VAS). It also evaluates overall well-being through the Modified Naranjo Criteria, determines the prevalence of Ganglion cysts based on age, sex, socio-economic status, and occupation among NIH OPD/IPD patients, and identifies the most frequently indicated homoeopathic medicines along with their miasmatic background for effective management. Adults aged 05-65 years suffering from ganglion cysts of hand, fluent in English, Hindi, or Bengali, and willing to provide consent will be included. Exclusion criteria include cases requiring immediate surgery or life support, those with uncontrolled systemic illness, life-threatening infections, or organ failure, unstable psychiatric conditions, pregnant or lactating women, substance abuse or dependence, self-reported immunocompromised state, and patients under homeopathic treatment for chronic disease within the last three months or unwilling to give consent. Individualized homeopathic remedies will be selected based on repertorization (RADAR OPUS) and Materia Medica, following Hahnemannian principles, with monthly follow-ups for six months to assess symptom changes. The outcome assessment of the patients shall be calculated as per changes in and applying the core interpretation of Patient Rated Hand/ Wrist Evaluation (PRHWE) Score, Visual analogue scale (VAS) and Modified Naranjo Criteria at baseline and after 6 months.

研究设计

研究类型
Interventional
分配方式
Not Applicable
盲法
Not Applicable

入排标准

年龄范围
5.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Diagnosed and stable patient suffering from Ganglion cyst of hand.
  • Age 5-65 years.
  • Ability to read Bengali or Hindi or English or understand any.
  • Providing written informed consents/assent form.

排除标准

  • Cases require any immediate surgical intervention or life support measures for any other pathology.
  • Cases suffering from uncontrolled systemic illness or life-threatening infections.
  • Unwilling to take part and not giving consent to join the study.
  • Diagnosed cases of unstable mental or psychiatric illness or other uncontrolled or life threatening illness affecting quality of life or any organ failure.
  • Pregnant women and lactating mothers
  • Substance abuse and/or dependence.
  • Self-reported immune-compromised state, and
  • Undergoing homoeopathic treatment for any chronic disease within last 3 months.

结局指标

主要结局

Score, Visual analogue scale (VAS) and Modified Naranjo Criteria.

时间窗: At baseline and 6 months

The outcome assessment of the patients shall be calculated as per changes in and

时间窗: At baseline and 6 months

applying the core interpretation of Patient Rated Hand/ Wrist Evaluation (PRHWE)

时间窗: At baseline and 6 months

次要结局

未报告次要终点

研究者

申办方类型
Government medical college

研究点 (1)

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