Nidanpanchatamak Study Of Amavata [Rheumatoid Arthritis] With Upasayatmaka Effect Of Pathyadi Churna w.s.r. To Biological Marker
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
- A joint involvement (0–5 points)
研究概览
简要总结
Introduction: The study is an open label, single arm, prospectiveclinical trial in Amavata (Rheumatoid Arthritis) (n=60)selected using the convenience (non-random) sampling technique with pre andpost design conducted in tertiary Ayurveda Hospital attached to VYDS AyurvedaMedical College located in district Bulandshahar India, irrespective of caste, sex, occupation andsocio-economic status etc.
**Diagnostic Criteria :**Angamarda, Aruchi, Trishna, Alasya, Gaurava, Jwara, Apaka, Sandhi Shotha, and 2010 ACR-EULAR 114 classificationcriteria for Rheumatoid Arthritis with grading score.
LABORATORYINVESTIGATION: ESR, (Hb gm %),Urine Analysis, Serum uric acid level was estimated to rule out the possibility of other pathological conditions.
Bio- Markers :Rheumatoid Factor (RF), C- Reactine Protein (CRP).
POSOLOGY: Drug- Pathyadi Churna (Bhavaprakash ) 3g BID with Luke warm water For 30 days.
FINAL ASSESSMENT OF RESULT: Patients will be assessed before & after the treatment (30 days) for improvement in symptoms on the basis of said scoring pattern & percentage improvement would be calculated.
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
- 20.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Angamardha, Aruchi, Trishna, Alasya, Gaurava, Jwara, Apaka, Sandhi Shotha, and 2010 ACR-EULAR classification criteria for Rheumatoid Arthritis.
- •Subjects aged between 20-60 years
- •Subjects of either gender
- •Subjects willing to participate in the study and ready to sign informed consent form.
排除标准
- •Subjects with known case of essential hypertension and uncontrolled diabetes mellitus
- •Subjects with known case of impaired renal, hepatic and cardiac function
- •Subjects with known case of systemic arthritis (gout, tubercular arthritis, systemic lupus erythematosus, psoriatic arthritis)
- •Pregnant and Lactating women.
结局指标
主要结局
A joint involvement (0–5 points)
时间窗: 30 days
1 large joint 0
时间窗: 30 days
2–10 large joints 1
时间窗: 30 days
1–3 small joints 2
时间窗: 30 days
Low positive RF or low positive ACPA 2
时间窗: 30 days
4–10 small joints 3
时间窗: 30 days
10 joints including at least one small joint 5
时间窗: 30 days
B Serology 0–3 points
时间窗: 30 days
Negative RF and negative ACPA 0
时间窗: 30 days
High positive RF or high positive ACPA 3
时间窗: 30 days
C Acute-phase reactants 0–1 point
时间窗: 30 days
Normal CRP and normal ESR 0
时间窗: 30 days
Abnormal CRP or abnormal ESR 1
时间窗: 30 days
D Duration of symptomsed
时间窗: 30 days
6 weeks 0
时间窗: 30 days
≥6 weeks 1
时间窗: 30 days
次要结局
- Ayurvedic Assessment parameter(1 Angamarda)