A Triple Arm Open Label Randomized Controlled Comparative Clinical Trial To Evaluate The Efficacy Of Agni Karma, Jalauka Avacharana And Cupping Therapy In The Management Of Avabahuka [Frozen Shoulder
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- The Proportion of patient showing improvement in the level of range of motion after trial.
研究概览
简要总结
In this open-label, controlled comparative clinical trial, 45 patients with Avabahuka (frozen shoulder) will be enrolled after meeting the necessary criteria. In Group A, 15 patients would be treated with Bindu-type Agnikarma, an Ayurvedic procedure that uses a red-hot Panchadhatu Shalaka, in four sessions spaced 7 days apart. Group B would also have 15 patients, who would receive Jalauka Avacharana (Leech therapy) in four sessions, with the same 7-day intervals. In Group C, the last 15 patients will undergo Cupping Therapy , also over four sessions at 7-day intervals. Before starting the treatment, all patients would be tested for essensial investigation to ensure they meet the study’s requirements.
The effectiveness of the treatments will be measured by looking at the range of motion (ROM) in the shoulder using a grading scale i.e. Gradiation of Motion of Shoulder Joint Scale and assessment of pain and disability with The Shoulder Pain and Disability Index (SPADI) scale. The ROM will be measured using a goniometer, while the SPADI will help to evaluate pain and disability by questionnaire. After the treatments, the results will be analyzed statistically.
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
- 30.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients having the typical sign and symptoms of Avabahuka and Frozen shoulder between Age group of 30-50 years, of either gender.Patients willing to undergo trial.Patients suffering from controlled Diabetes Mellitus.Patient suitable for Agnikarma.
- •Jalauka Avacharna and Cupping therapy.Patient had signed the consent form.
排除标准
- •Age below 30 years and above 50 years,Suffering from specific arthritis like OA, RA etc.,Patients of shoulder joint fracture within last six months,Patients having any surgical procedure on shoulder joint in the last six months,Patients suffering from uncontrolled Diabetes Mellitus and hypertension, and localized skin infection.
- •HIV, Hepatitis, etc.
- •Haematological diseases,Auto Immune disorder like SLE, RA etc.,Pregnant women and lactating mothers, Patient not suitable for Agnikarma, Jalauka Avacharna and Cupping therapy,Patient had not signed the consent form.
结局指标
主要结局
The Proportion of patient showing improvement in the level of range of motion after trial.
时间窗: 1st- 0 Day | 2nd- After completion of Trial | 3rd- 2 week after completion of follow up after trial
次要结局
- Reduction in the symptoms of patient sandhi shool (pain).(Reduction in the symptoms of patient stabadhta (stiffness).)
研究者
Dr Naveen Kumar
Institute For Ayurved Studies and Research Shri Krishna AYUSH University