A comparative clinical study to evaluate the efficacy of Mustadi Aasthapan Basti and Guduchiyadi Aasthapan Basti in the management of Kati-Prishtha-Trik Grah in Gambhir Vatrakta w.s.r. Ankylosing Spondylitis.
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To compare efficacy of Mustadi Aasthapan Basti and Guduchiyadi Aasthapan Basti in the management of Kati-Prishtha-Trik Grah in Gambhir Vatrakta w.s.r. Ankylosing Spondylitis.
研究概览
简要总结
Ankylosing Spondylitis is characterized by chronic inflammatory arthritis predominantly affecting the sacroiliac joints and spine which can progress to bony fusion of the spine . Chronic back pain and progressive spinal stiffness are the most common features of the disease. Involvement of the spine and sacro-iliac joints, peripheral joints, digits, entheses are characteristics of the disease. Impaired spinal mobility, postural abnormalities, hip pain, peripheral arthritis, enthesitis, and dactylitis are all associated with ankylosing spondylitis. It is present in 1% to 6% of adults inheriting HLA B27, whereas the prevalence is 10% to 30% among HLA B27 positive adults. The onset is typically between the age of 20 to 30 years, with a male preponderance of about 3:1. The global prevalence is less than 0.5% in most populations2.There is no direct correlation of ankylosing spondylitis in ayurveda, However, on the basis of pathogenesis and symptoms ankylosing spondylitis can be correlated to kati-prishtha-trik grah of gambhir vatarakta. Sandhi shoth (jonit inflammation), dhah (joint warmth), stabdhta (joint stiffnes), kathinyata (limited joint movement), abhyantar sandhipeeda (joint tenderness), toda (thrombingpain) in kati (pelvic region), prishtha (posterior region of trunk from neck to pelvis) and trik pradesh (region around shoulder girdle) are the cardinal features of ankylosing spondylitis. In ayurveda, Grah (stiffness) is characteristics feature of vata and kapha dosha. Hence, In the treatment of kati-prishtha-trik grah in gambhir vatarakta (ankylosing spondylitis) primary concern should be effective treatment of kapha and vata dosha, which includes sequential administration of nadi swedan and basti. Basti is the best line of treatment in the management of aggravated vata dosha. Further mustadi aasthapan basti is specially indicated for vatarakta and guduchiyadi aasthapan basti is indicated for vataja vyadhi.
It will be Simple randomized parallel group clinical perspective study with each group 30 patients of Gambhir vatarakta will be selected for study.
The drugs will be prepared in the form of Kwatha for Aasthapana Basti and Murchita Tila Taila for Anuvasana Basti.
Duration of treatment - 16 days
Mode of Administration - Anorectal
Dose - 120 ml
Follow up - Follow up will be done on every 14th, 28th & 42nd day
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients presenting with classical picture of Gambhir vatarakta in katiprishtha-trik grah will be selected irrespective of cast, religion and profession.
- •Patients with in the age group of 18 to 60 years.
- •Patients who are Basti-Yogya.
- •HLA B27 positive.
排除标准
- •Patients having age below 18 years and more than 60 yrs.
- •Low back pain due to fracture of vertebra or traumatic history, Potts spine, tumor of spine, chronic systematic illness, Pregnant and Lactating women.
- •Patient who are Contra indicated for Basti.
结局指标
主要结局
To compare efficacy of Mustadi Aasthapan Basti and Guduchiyadi Aasthapan Basti in the management of Kati-Prishtha-Trik Grah in Gambhir Vatrakta w.s.r. Ankylosing Spondylitis.
时间窗: Duration of treatment - 16 days | Mode of Administration - Anorectal | Dose - 120 ml | Follow up - Follow up will be done on every 14th, 28th & 42nd day | Study will be completed in stipulated time period i.e 1 year
次要结局
- To collect literature of Basti Karma from different text of Ayurveda(To collect literature of Kati-Prishtha-Trik Grah in Gambhir Vatrakta w.s.r. Ankylosing Spondylitis from different text of ayurveda and modern)
