CTRI/2024/09/073613尚未招募2/3 期
A comparative clinical study between Raktamokshana and Physiotherapy in management of Katigraha- A randomized comparative clinical trial
Shree swaminarayan ayurvedic college1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年10月1日最近更新:
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Katisula(Pain in the Back region)
研究概览
简要总结
This study is an open-label randomized comparative clinical trial to evaluate the efficacy of Raktamokshana. A total 40 number of patients will be selected in the present study. 20-20 patients for each group. In trial group will do raktamokshna with modified shring yantra (cupping set) in the lumber region for twice a month (15 days interval) and its follow-up period is 2 months. In control group will do Physical physiotherapy in lumber region for once a day for 1 month and its follow-up period is 2 months. Clinical data obtained will be summarized at the end of the study. The conclusion will be made after the statistical analysis of the data.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients who are indicated (Yogya) for Raktamokshana.
- •Age between 18 to 40 years.
- •Subjects of either gender.
- •Patients suffering from symptoms of, (Katisula)Pain in the Back region since 6 weeks (Katistambha)Stiffness in the Back region since 6 weeks Associated complaints, (Akunchana prasaran pravrutti savedana)Restricted movement since 6 weeks.
排除标准
- •Patients who are contraindicated ( Ayogya) for Raktamokshana.
- •Uncontrolled other systemic disorders like Diabetes mellitus, Hypotension, etc.
- •Subjects with congenital anomalies of the back region like spina bifida, vertebral stenosis, lumbarization, sacralization, lordosis, etc.
- •Neuromuscular diseases like Myasthenia gravis, Muscular dystrophy, neuromyotonia, etc.
- •Patient of any neurological disorders like sciatica etc.
- •The patient also has osteoarthritis, osteoporosis, fracture, lumbar herniated disc, lumbar spinal stenosis, ankylosing spondylitis, etc.
- •Female with gynecological disorders like uterine dysfunction and endometriosis and female in menstrual period and menopause.
- •Patients suffering from serious blood disorders like Anemia & life-threatening diseases like HIV and HEPATITIS.
- •Tuberculosis Malignancy Pregnancy RED FLAG warning signs require immediate or urgent evaluation, Cauda equina syndrome-Saddle anesthesia, Motor deficit at multiple levels, Urinary retention, Fecal incontinence Significant or progressive neurological deficits- Progressive motor weakness, Severe or incapacitating back or leg pain (e.g., requiring hospitalization, precluding walking, or significantly limiting activities of daily living) Cancer-History of cancer with new onset low back pain, Unexplained weight loss Vertebral infection-Fever, IV drug use, Recent infection Vertebral compression fracture or fracture due to acute injury-History of osteoporosis, Use of corticosteroids, Older age Inflammatory back pain- Morning stiffness lasting longer than 30 minutes (especially upon rising) in patients under age 40.
结局指标
主要结局
Katisula(Pain in the Back region)
时间窗: 1 Month
Katistambha(Stiffness in the Back region)
时间窗: 1 Month
次要结局
- Akunchana prasaran pravrutti savedana(Restricted movement)
研究者
Dr Dhyankumar P Patel
Shree swaminarayan ayurvedic college
研究点 (1)
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