Effectiveness of Individualised Homoeopathic medicine vs Angustura Vera in management of Primary Osteoarthritis of Knee Joint A Double Arm Prospective Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- To access the reduction of clinical symptoms of primary osteoarthritis
研究概览
简要总结
Osteoarthritis (OA) is a heterogeneous group of degenerative joint disease of multifactorial origin, characterised by defective integrity and progressive loss of articular cartilage, subchondral bone remodelling, joint space narrowing and bone spur formation, as well as synovial inflammation.
The aim of this study is to evaluate the Effectiveness of Individualized Homoeopathic (IH) medicines versus Angustura vera in the management of Primary Osteoarthritis of knee.
Primary Objective: - To access the reduction of clinical symptoms of primary osteoarthritis of knee joint using KOOS scale.
Secondary Objective: - To assess the improvement in pain using VAS scale.
- To assess the effect of medicine on symptoms of patients using MYMOP2
Research question: Is there any significant difference between individualized homoeopathy (IH) and Angustura Vera in the management of knee osteoarthritis?
Hypothesis:
-
Null hypothesis (H0): There will be no difference between individualized homoeopathy (IH) and Angustura vera in the management of knee osteoarthritis
-
Alternative hypothesis (HA): There will be significant difference between individualized homoeopathy (IH) and Angustura vera in the management of knee Osteoarthritis.
Source of data: Out patient and in- patient department of Nehru Homoeopathic Medical college and hospital
Study duration: 12 months
Study design: A Double Arm, Prospective Clinical Trial
Sample size- Total 80 patients will be included in trial. 40 in HI arm and 40 in Comparator arm.
Inclusion and exclusion criteria
Inclusion criteria-
Patient with clinical symptoms of osteoarthritis of knee joint using standard American College Rheumatology guidelines.
Patients of either sex.
Exclusion criteria-
Patients with any other systemic disorder.
Patients not willing to give written consent for the study.
Undergoing Homeopathic treatment for any other disorder.
Simultaneous participation in any other clinical trial.
Self-reported immune-compromised state (e.g., HIV)
Vulnerable population – unconscious, non-ambulatory, too sick for consultation, differently abled, terminally or critically ill subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 35.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patient with clinical symptoms of osteoarthritis of knee joint usingstandard American College Rheumatology guidelines.
- •2.Patients of either sex.
排除标准
- •1.Patients with any other systemic disorder.
- •Patients not willing to give written consent for the study.
- •3.Undergoing Homeopathic treatment for any other disorder.
- •4.Simultaneous participation in any other clinical trial.
- •Self-reported immune-compromised state (e.g., HIV) 6.Vulnerable population – unconscious, non-ambulatory, too sick for consultation, differently abled, terminally or critically ill subjects.
结局指标
主要结局
To access the reduction of clinical symptoms of primary osteoarthritis
时间窗: Baseline and at every month
of knee joint using KOOS scale
时间窗: Baseline and at every month
次要结局
- To assess the improvement in pain using VAS scale.(- To assess the effect of medicine on symptoms of patients using MYMOP2.)
研究者
Dr. Priya Gautam
Nehru Homoeopathic Medical College And Hospital