Effect of Individualised Homoeopathic Medicine in 50 Millesimal Potency in the Management of Ankylosing Spondylitis and Its Impact on Quality of Life – A Prospective Open-Label Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
研究概览
简要总结
This is a single arm prospective interventional open label non randomized clinical study conducted over a period of 18 months. Participants will be adults aged 18 to 45 years diagnosed with Ankylosing Spondylitis according to the Assessment of SpondyloArthritis International Society ASAS classification criteria.
Eligible participants will have active disease symptoms including chronic inflammatory back pain and morning stiffness with impaired functional status and reduced quality of life as assessed by validated clinical indices. Participants must be able to provide informed consent understand the study language and comply with study procedures.
Participants will be excluded if they have other inflammatory or autoimmune arthritides severe systemic illness spinal trauma or surgery pregnancy or lactation serious psychiatric disorders or if they are receiving long term immunosuppressive or biological therapy. Patients unwilling or unable to adhere to follow up schedules will also be excluded.
All eligible participants will receive individualized homoeopathic medicines selected based on the totality of symptoms and constitutional characteristics. Medicines will be prescribed in fifty millesimal LM potency sourced from GMP certified manufacturers with dosage and repetition individualized according to patient response. Treatment outcomes will be assessed at baseline to six months using BASDAI and ASQoL scores to evaluate changes in disease activity and quality of life.
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
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •Cases fulfilling the diagnostic criteria for Ankylosing Spondylitis (ICD 10 M45) according to the ASAS classification criteria for axial spondyloarthritis Patients aged 18 to 45 years Patients of all sexes religions and socio-economic backgrounds Patients who have not taken any conventional treatment for AS in the last 4 weeks Patients who are willing to give consent Patients who can read or understand either English Hindi or Bengali.
排除标准
- •Patients diagnosed with life-threatening diseases, uncontrolled systemic illnesses, immunocompromised states psychiatric disorders or malignancy Patients unwilling to undergo required investigations if needed Patients currently on NSAIDs DMARDs or biological therapy for AS Pregnant women and lactating mothers Patients with a history of substance abuse and/or dependence.
研究者
Dr Gone Maniprasad
National Institute of Homoeopathy