A comparative controlled clinical study to evaluate the effect of Raktamokshana by Shringa and cupping method in the management of Katishoola with special reference to low back pain.
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- To evaluate the comparative clinical efficacy of Raktamokshana by Shriga and Cupping method in the management of Katishoola with special reference to Low back pain.
研究概览
简要总结
This study is Randomized controlled clinical study, trial conduction the comparative efficacy of Raktamokshana panchakarma therapy using two methodologies one is by cupping method and another is Shringa method. In which patient suffering from Low back pain who is the inclusion criteria will be involved in the study. 90 patients will be randomly divided in two groups in which each group will having 45 no of patients. Both group will received Rasnadi Guggulu in the form of tablet and dose will be 500mg twice a day for 14 days with Anupana Koshna Jala (Luke warm water) through Oral route (Mouth).And In Group A and B Raktmaokshana will be done On 0th day(Basline) On 7th day On 14th Day that is completion of trail for patients and then on 21st day after stating of trail again follow up study will be done. Assessment of Pain by VAS Scale will be done before procedure and after procedure on 0th ,7th day,14th day & on 21st day (1st follow up study), Assessment of Criteria Subjective & Objective Before treatment (B.T.) i.e. 0th day 7th day, 14th day (After treatment-A.T.) & on 21st day(1st follow up study) will be done. Primary and Secondary outcome will be observed and studied as soon as complete trail will be done.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 16.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients fulfilling the diagnostic criteria.
- •â€¢ Duration not more than 6 weeks, • Patients of both gender aged between 16-70 years.
- •â€¢ Irrespective of sex age education for all category and socieo-economical status.
- •â€¢ Patient willing for trial and giving written consent.
- •â€¢ Patient who will be comfortably able to complete the Raktamokshana in Sitting with elevated back and forward bending head or prone position.
排除标准
- •Known Case of Any systemic disorder or any serious illness, maligancny, infectious disease , congenital problem, hypertension , HIV positive , HbsAg positive or Covid 19 positive patients, Any known case of Neuroloigcal disorders.
- •â€¢ Patients who is pregnant will be excluded for Raktamokshana.
- •â€¢ Patients is having any history of cardiac disorder or on any blood thinner medicine or known case of any heamtological disorders.
- •â€¢ Patient having Hemoglobin percentage less than 12 for women and less than 13 for men.
- •â€¢ Age less than 16 and beyond 70 will not be included in studies.
- •â€¢ Earlier went to the Cupping therapy or Shringa therapy or Cupping therapy.
- •â€¢ Patients having associated diseases like Tuberculosis, Fractures, and other complications.
- •â€¢ Patients having marked deformities of spinal column.
- •Such as Sacralisation Spinal stenosis, Disturbed bowel-bladder control.
结局指标
主要结局
To evaluate the comparative clinical efficacy of Raktamokshana by Shriga and Cupping method in the management of Katishoola with special reference to Low back pain.
时间窗: 10 months
次要结局
- 1) To evaluate the clinical efficacy of Raktamokshana by Shringa method in the management of Katishoola with special reference to low back pain.
- 2) To evaluate the clinical efficacy of Raktamokshana by Cupping method in the management of Katishoola with special reference to low back pain.(1 months)
- 3) To Compare clinical efficacy of Raktmokshana by Shringa and Cupping method in the management of Katishoola with special reference to low back pain.(1 months)
- 4) Study on Cupping method for Raktamokshana and possible establishment as comparing to Shringa method.(1 months)
研究者
Dr Vipul Ajitkumar Gangwal
Shiva Trusts Yashwantrao Chavan Ayurvedic Medical College