In Vitro Study of anti-inflammatory activity of Homoeopathic medicine TINOSPORA CORDIFOLIA and clinical verification in Rheumatoid Arthritis patients-A Randomized controlled clinical trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- 1)Study Title:To assess anti-inflammatory activity.
研究概览
简要总结
This consist of two parts.
First part contain in vitro study of anti-inflammatory effect of Tinospora Cordifolia in Rheumatoid Arthritis blood sample collected from Inbiotics (ISO13485:2016) research laboratory, Nagercoil.
And the second part consist of an in vivo Clinical evaluation anti-inflammatory effect of Tinospora Cordifolia in Rheumatoid Arthritis patients - A randomized controlled clinical trial. One group will be given by Homoeopathic medicine Tinospora Cordifolia and the other group will receive Homoeopathic constitutional medicine by randomization .Diagnosis of the case will based on ACR/EULAR criteria for Rheumatoid Arthritis and the evaluation of the study will be based on the estimation of Disease Activity Score 28 before and after the study . Each case will be evaluated for 3 months .Obtained values will be taken for analysis. Outcome will be measured by the reduction in Disease Activity Score 28 in all cases .
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
- 20.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Those patients satisfying 2010 ACR/EULAR criteria for Rheumatoid Arthritis 2.Subjects belonging to both sexes 3.Patients belonging to the age group 20-70 years.
排除标准
- •1.Cases associated with malignancies, renal failure, hepatic failure.
- •2.Pregnant females 3.Cases with disease activity score 28 more than 7.5(high disease activity).
结局指标
主要结局
1)Study Title:To assess anti-inflammatory activity.
时间窗: 1)Study Title:To assess anti-inflammatory activity. | Description:By assessing Percentage of inhibition | Interval:48 hours | 2)Clinical study | Title:To assess the reduction in Disease Activity Score 28 | Description:Disease Activity Score 28 final value - Disease Activity Score 28 initial value | Interval:3months
Description:By assessing Percentage of inhibition
时间窗: 1)Study Title:To assess anti-inflammatory activity. | Description:By assessing Percentage of inhibition | Interval:48 hours | 2)Clinical study | Title:To assess the reduction in Disease Activity Score 28 | Description:Disease Activity Score 28 final value - Disease Activity Score 28 initial value | Interval:3months
Interval:48 hours
时间窗: 1)Study Title:To assess anti-inflammatory activity. | Description:By assessing Percentage of inhibition | Interval:48 hours | 2)Clinical study | Title:To assess the reduction in Disease Activity Score 28 | Description:Disease Activity Score 28 final value - Disease Activity Score 28 initial value | Interval:3months
2)Clinical study
时间窗: 1)Study Title:To assess anti-inflammatory activity. | Description:By assessing Percentage of inhibition | Interval:48 hours | 2)Clinical study | Title:To assess the reduction in Disease Activity Score 28 | Description:Disease Activity Score 28 final value - Disease Activity Score 28 initial value | Interval:3months
Title:To assess the reduction in Disease Activity Score 28
时间窗: 1)Study Title:To assess anti-inflammatory activity. | Description:By assessing Percentage of inhibition | Interval:48 hours | 2)Clinical study | Title:To assess the reduction in Disease Activity Score 28 | Description:Disease Activity Score 28 final value - Disease Activity Score 28 initial value | Interval:3months
Description:Disease Activity Score 28 final value - Disease Activity Score 28 initial value
时间窗: 1)Study Title:To assess anti-inflammatory activity. | Description:By assessing Percentage of inhibition | Interval:48 hours | 2)Clinical study | Title:To assess the reduction in Disease Activity Score 28 | Description:Disease Activity Score 28 final value - Disease Activity Score 28 initial value | Interval:3months
Interval:3months
时间窗: 1)Study Title:To assess anti-inflammatory activity. | Description:By assessing Percentage of inhibition | Interval:48 hours | 2)Clinical study | Title:To assess the reduction in Disease Activity Score 28 | Description:Disease Activity Score 28 final value - Disease Activity Score 28 initial value | Interval:3months
次要结局
- Comparison of Therapeutic effectiveness of Homoeopathic medicine Tinospora cordifolia & Homoeopathic constitutional medicines among the group(After 1 year(after completion of the study))
研究者
Dr Adhith T G
PG Graduate Scholar