A Comparative Clinical Study to evaluate the efficacy of Ajamodadya Vataka and Rasnadashamoola Kwatha in the management of Amavata W.S.R to Rheumatoid Arthritis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Changes in the score of ACR,EULAR criteria
研究概览
简要总结
Thedisease ‘Amavata’ is very similar to Rheumatoid Arthritis. It is chronicin nature and effect mostly the middle age group. It is one of the commondebilitating diseases by virtue of it’s chronicity and implication. Itis mostly the disease of Madhyam Rog Marg and having ChirkariSwabhava. Sometimes it can also be manifested as the acute case due totheir similar mode of presentation. The disease Rheumatoid Arthritis can bebroadly grouped under the heading ‘Amavata’. Here ‘Ajamodadya Vataka’, ‘RasnasadashmoolakamKwatha’ along with ‘RukshaSweda’ are selected for this study**.Above mentioned drugs are easilyavailable, cost effective and easy to administer in the patients. That is thebasic reason to select these drugs for present clinical trial.**40 Clinicallydiagnosed and registered patients of **‘Amavata’will be divided randomly into two groups. Each group will have 20patients.
- Group A-20 clinically diagnosed and registered patients of ‘Amavata’ will be treated by ‘Ajamodadya Vataka’ 2 Tab (each Tab 1gm) three times in a day with lukewarm water after meals, for 30 days as Oral medication with ‘Ruksha sweda’ two times a day for 30 days
- Group B- 20 clinically diagnosed and registered patients of ‘Amavata’ will be treated by ‘Rasnadashmoolakam Kwatha’ 40 ml added with ‘Eranda Tail’ 10ml(based on the koshta of the patient i.e, krura,mridu and madhyama) two times in a day (morning & evening) for 30 days before meals orally and ‘Ruksha sweda’ two times a days for 30 days
1.Open label. 4.Interventional.
2.Randomized. 5.Prospective type.
3.Single Centre.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 20.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients willing to sign consent form for the clinical trial.
- •Patients between the age group of 20 to 60 years, irrespective of sex and socio- economic status.
- •Patients having signs and symptoms of ‘Amavata roga’ according to classical text of Ayurveda as a subjective criteria & according to modern text books w.s.r. Rheumatoid Arthritis as a objective criteria including Seropositive (RA Factor- Positive) as well as Seronegative (RA Factor-Negative) both.
- •Patients with chronicity of less than 5 years.
排除标准
- •1.Patients having severe joint deformities.
- •2.Patients suffering from paralysis.
- •3.Patients having any type of arthropathy such as Neoplasm of spine, Gout, Ankylosing spondylosis, Traumatic arthritis and Pyogenic osteomyelitis etc .
- •4.Patients having associated Cardiac disease, Tuberculosis, Diabetes mellitus, Malignant Hypertension, Renal Function Impairment, Hypothyroidism, RHD etc.
- •5.Patients with extremely reduced joint space.
- •6.Pregnant women and lactating mother.
结局指标
主要结局
Changes in the score of ACR,EULAR criteria
时间窗: 30 days
次要结局
- Changes in the laboratory parameters and the Lakshanas of Amavata like Jwara,Angamarda,Sandhishoola etc(30 days)