A COMPARATIVE CLINICAL STUDY TO EVALUATE THE EFFICACY OF SHOOLAPRSHAMANA CAPSULE AND HINGUTRIGUNA TAILA CAPSULE IN THE MANAGEMENT OF AMAVATA WITH SPECIAL REFERENCE TO RHEUMATOID ARTHRITIS
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 165
- 试验地点
- 1
- 主要终点
- Subjective parameters
研究概览
简要总结
Amavata is a Pain predominant joint disorder which if not managed in time may prove crippling to the life of the patient, which has been causing immense suffering to the people throughout the world. Prevalance rate in India 0.75%.The ingredients of Shoolaprashamana capsule are anti-arthritic ,analgesic ,anti-inflammatory and muscle relaxants and specify aggravated vata dosha.The ingredients of Hingutrigunataila cap are Hingu,Saindhava,Eranda taila and Rasona.However using combination of drugs can be a novel approach in the treatment of Rheumatoid Arthritis.Moreover capsule is having easy palatability and is patient friendly .To get better idea about its efficacy and clinical spectrum a Comparative CLINICAL SYUDY is taken to see the efficacy of Shoolaprashamana capsule and Hingutriguna taila capsule.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 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 diagnosed as having Amavata on the basis of signs and symptoms that are typically diagnosed as classical symptoms and Rheumatoid Arthritis on basis of ACR CRITERIA FOR DIAGNOSING RHEUMATOID ARTHRITIS.
排除标准
- •patients suffering from complications of Aamavata Juveline RA Septic arthritis Rheumatic Heart Disease RA with involvement of other organs.
结局指标
主要结局
Subjective parameters
时间窗: OBJECTIVE PARAMETERS | C-RP | ESR | RA factor | Anti-CCP | ASSESSMENT CRITERIA | Assessment will be made for clinical signs and symptoms & investigations Statistical analysis | package of version 20 will be done by using chi-square/Fisher’s test for subjective | parameters & students t test for objective parameters. | SAMPLE SIZE 120PATIENTS | 60 Patients in each group and treatment for 1month with follow up of 15days
Sandhi shoola
时间窗: OBJECTIVE PARAMETERS | C-RP | ESR | RA factor | Anti-CCP | ASSESSMENT CRITERIA | Assessment will be made for clinical signs and symptoms & investigations Statistical analysis | package of version 20 will be done by using chi-square/Fisher’s test for subjective | parameters & students t test for objective parameters. | SAMPLE SIZE 120PATIENTS | 60 Patients in each group and treatment for 1month with follow up of 15days
Sandhi shotha
时间窗: OBJECTIVE PARAMETERS | C-RP | ESR | RA factor | Anti-CCP | ASSESSMENT CRITERIA | Assessment will be made for clinical signs and symptoms & investigations Statistical analysis | package of version 20 will be done by using chi-square/Fisher’s test for subjective | parameters & students t test for objective parameters. | SAMPLE SIZE 120PATIENTS | 60 Patients in each group and treatment for 1month with follow up of 15days
Sparshasahatva
时间窗: OBJECTIVE PARAMETERS | C-RP | ESR | RA factor | Anti-CCP | ASSESSMENT CRITERIA | Assessment will be made for clinical signs and symptoms & investigations Statistical analysis | package of version 20 will be done by using chi-square/Fisher’s test for subjective | parameters & students t test for objective parameters. | SAMPLE SIZE 120PATIENTS | 60 Patients in each group and treatment for 1month with follow up of 15days
Stabdata
时间窗: OBJECTIVE PARAMETERS | C-RP | ESR | RA factor | Anti-CCP | ASSESSMENT CRITERIA | Assessment will be made for clinical signs and symptoms & investigations Statistical analysis | package of version 20 will be done by using chi-square/Fisher’s test for subjective | parameters & students t test for objective parameters. | SAMPLE SIZE 120PATIENTS | 60 Patients in each group and treatment for 1month with follow up of 15days
Angamarda
时间窗: OBJECTIVE PARAMETERS | C-RP | ESR | RA factor | Anti-CCP | ASSESSMENT CRITERIA | Assessment will be made for clinical signs and symptoms & investigations Statistical analysis | package of version 20 will be done by using chi-square/Fisher’s test for subjective | parameters & students t test for objective parameters. | SAMPLE SIZE 120PATIENTS | 60 Patients in each group and treatment for 1month with follow up of 15days
Aruchi
时间窗: OBJECTIVE PARAMETERS | C-RP | ESR | RA factor | Anti-CCP | ASSESSMENT CRITERIA | Assessment will be made for clinical signs and symptoms & investigations Statistical analysis | package of version 20 will be done by using chi-square/Fisher’s test for subjective | parameters & students t test for objective parameters. | SAMPLE SIZE 120PATIENTS | 60 Patients in each group and treatment for 1month with follow up of 15days
Alasya
时间窗: OBJECTIVE PARAMETERS | C-RP | ESR | RA factor | Anti-CCP | ASSESSMENT CRITERIA | Assessment will be made for clinical signs and symptoms & investigations Statistical analysis | package of version 20 will be done by using chi-square/Fisher’s test for subjective | parameters & students t test for objective parameters. | SAMPLE SIZE 120PATIENTS | 60 Patients in each group and treatment for 1month with follow up of 15days
Objective parameters
时间窗: OBJECTIVE PARAMETERS | C-RP | ESR | RA factor | Anti-CCP | ASSESSMENT CRITERIA | Assessment will be made for clinical signs and symptoms & investigations Statistical analysis | package of version 20 will be done by using chi-square/Fisher’s test for subjective | parameters & students t test for objective parameters. | SAMPLE SIZE 120PATIENTS | 60 Patients in each group and treatment for 1month with follow up of 15days
C-RP
时间窗: OBJECTIVE PARAMETERS | C-RP | ESR | RA factor | Anti-CCP | ASSESSMENT CRITERIA | Assessment will be made for clinical signs and symptoms & investigations Statistical analysis | package of version 20 will be done by using chi-square/Fisher’s test for subjective | parameters & students t test for objective parameters. | SAMPLE SIZE 120PATIENTS | 60 Patients in each group and treatment for 1month with follow up of 15days
ESR
时间窗: OBJECTIVE PARAMETERS | C-RP | ESR | RA factor | Anti-CCP | ASSESSMENT CRITERIA | Assessment will be made for clinical signs and symptoms & investigations Statistical analysis | package of version 20 will be done by using chi-square/Fisher’s test for subjective | parameters & students t test for objective parameters. | SAMPLE SIZE 120PATIENTS | 60 Patients in each group and treatment for 1month with follow up of 15days
Anti-CCP
时间窗: OBJECTIVE PARAMETERS | C-RP | ESR | RA factor | Anti-CCP | ASSESSMENT CRITERIA | Assessment will be made for clinical signs and symptoms & investigations Statistical analysis | package of version 20 will be done by using chi-square/Fisher’s test for subjective | parameters & students t test for objective parameters. | SAMPLE SIZE 120PATIENTS | 60 Patients in each group and treatment for 1month with follow up of 15days
RA factor
时间窗: OBJECTIVE PARAMETERS | C-RP | ESR | RA factor | Anti-CCP | ASSESSMENT CRITERIA | Assessment will be made for clinical signs and symptoms & investigations Statistical analysis | package of version 20 will be done by using chi-square/Fisher’s test for subjective | parameters & students t test for objective parameters. | SAMPLE SIZE 120PATIENTS | 60 Patients in each group and treatment for 1month with follow up of 15days
Assesment will be done on Pain Swelling Morning stiffness Tenderness Fever ESR score C-RP score DAS 28 score Disability Index Quality of Life Index SF36 by adapting standard methods of scoring.
时间窗: OBJECTIVE PARAMETERS | C-RP | ESR | RA factor | Anti-CCP | ASSESSMENT CRITERIA | Assessment will be made for clinical signs and symptoms & investigations Statistical analysis | package of version 20 will be done by using chi-square/Fisher’s test for subjective | parameters & students t test for objective parameters. | SAMPLE SIZE 120PATIENTS | 60 Patients in each group and treatment for 1month with follow up of 15days
次要结局
- Incidence of Amavata as per Age Sex Lifestyle will be made in Parul Institute of Ayurveda,Parul University Vadodara,Gujarat(6months)