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临床试验/CTRI/2025/09/094672
CTRI/2025/09/094672尚未招募不适用

Efficacy of individualized homoeopathic intervention versus specific homoeopathic intervention using Guaiacum officinale in centesimal scale in reducing rheumatoid factor levels in patients of rheumatoid arthritis: A single-blind randomized controlled trial.

Nehru Homoeopathic Medical College And Hospital , Defence Colony B block ,New Delhi1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年10月13日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
Rheumatoid Factor levels

研究概览

简要总结

This study is a single-blind randomized controlled trial comparing the efficacy of individualized homoeopathic treatment versus specific homoeopathic intervention with Guaiacum officinale (centesimal scale) in patients with Rheumatoid Arthritis (RA). RA is a chronic autoimmune disease affecting 0.5–1% of the population, more common in women, and often associated with elevated Rheumatoid Factor (RF) levels, which predict severe disease. A total of 60 patients (30 in each group) will be enrolled and treated for 12 weeks. The primary outcome is reduction in RF levels, while secondary outcomes include improvement in disease activity using DAS28 score and clinical symptom relief. Patients in the experimental arm will receive individualized remedies based on totality of symptoms, while the comparator arm will receive Guaiacum officinale. Statistical analysis will assess within- and between-group differences. The trial seeks to establish whether individualized homeopathy offers superior benefits over a fixed specific remedy in RA management

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant 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.Age between 18–65 years.
  • 2.Cases of Both sexes.
  • 3.Diagnosed with RA as per 2010 ACR or EULAR criteria.
  • 4.Positive Rheumatoid Factor at baseline.
  • 5.Disease duration more than 6 weeks.
  • 6.Patient willing to participate voluntarily and provide written informed consent.

排除标准

  • 1.Patients with other severe systemic illnesses, malignant disorders, autoimmune diseases or any organic disease.
  • 2.Patients on long-term corticosteroids or immunosuppressants.
  • Any major surgery in the last 6 months.
  • 3.Patients under other medication from past 2-3 months for the same complaint.
  • 4.Unexplained weight loss.
  • 5.RA with severe joint deformities or contractures.
  • 6.Patients with cognitive impairment.
  • 7.Pregnant women and lactating mothers.

结局指标

主要结局

Rheumatoid Factor levels

时间窗: Rheumatoid Factor levels will be evaluated at baseline and at 12 weeks interval

次要结局

  • Disease Activity Score 28 (DAS 28)(DAS 28 Score will be evaluated at baseline and at 12 weeks interval)

研究者

发起方
Nehru Homoeopathic Medical College And Hospital , Defence Colony B block ,New Delhi
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Abhishek Kumar singh

Institute

研究点 (1)

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