Clinical evaluation of Vyoshadi guggulu with Vaitarana Basti in the management of Amavata (Rheumatoid Arthritis): A Controlled Clinical study.
试验速览
- 阶段
- 1/2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- 1.Simple Disease Activity Index (SDAI) of Rheumatoid Arthritis.
研究概览
简要总结
This study is a Open label Controlled Clinical trial to evaluate the Combined Clinical effect of Vyoshadi Guggulu along with Vaitarana Basti protocol in the Disease Activity of Rheumatoid arthritis. Subjects are allocated in to study and control groups respectively.
Study group includes 15 subjects Qualifying the Inclusion Criteria of the current study with Oral administration of Tab. Vyoshadi guggulu 500mg TID with lukewarm water After food for 31 days starting from Day-1 of the trial along with Vaitarana basti Protocol in the Yoga Basti pattern which includes alternate 5 Anuvasana basthi with Bruhat Saindhavadi taila and 3 Niruha basti, starting from Anuvasana basti which is given on consecutive days respectively ending with two Anuvasana basti for about 8 days (From Day 8- Day 15 of the trial period).
Control group includes 15 subjects Qualifying the Inclusion Criteria of the current study with Oral administration of Tab. Simhanada guggulu 500mg TID with lukewarm water After food for 31 days starting from Day-1 of the trial along with Vaitarana basti Protocol in the Yoga Basti pattern which includes alternate 5 Anuvasana basthi with Bruhat Saindhavadi taila and 3 Niruha basti, starting from Anuvasana basti which is given on consecutive days respectively ending with two Anuvasana basti for about 8 days (From Day 8- Day 15 of the trial period).
The Primary Outcome measure will be Simple Disease Activity Index (SDAI) of Rheumatoid Arthritis after 31 days.
The Secondary Outcome measure will be QoL- RA (Quality of Life- Rhematoid Arthritis) Questionnaire after 31 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 20.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •American College of Rheumatology/ European League against Rheumatism classification criteria for Rheumatoid Arthritis 2010, Subjects who fulfills a score of greater than or equal to 6/10 with Duration of symptoms greater than or equal to 6 weeks and Lesser than or equal to 10 years.
排除标准
- •Subjects, 1.On drug therapy such as DMRAD’s.
- •2.With Severe joint deformity.
- •3.Diagnosed with Spine, Gout, Ankylosing spondylosis, Osteoarthritis, Traumatic arthritis, Psoriatic arthritis, Infective Arthritis, Septic arthritis and Pyogenic Osteomyelitis.
- •4.With associated co-morbidities such as Cardiac disease, Pulmonary Tuberculosis, Uncontrolled Diabetes Mellitus, Malignant Hypertension, Renal Function Impairment.
- •5.Pregnant and Lactating Women.
- •6.Contraindicated for Basthi procedure.
结局指标
主要结局
1.Simple Disease Activity Index (SDAI) of Rheumatoid Arthritis.
时间窗: Day-0 & Day-32
2.Pratyatma Lakshanas Of Amavata.
时间窗: Day-0 & Day-32
次要结局
- QoL- RA (Quality of Life- Rhematoid Arthritis) Questionnaire(Day-0 & Day-32)