Analysis of the Effect of Ayurvedic Treatment Based on Vatarakta and Asthimajjagatavata Samprapti Pathways on the Clinico-radiological and Biochemical parameters in Patients of Non-traumatic Osteonecrosis of Femoral Head – A Black Box Clinical Trial
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Documentation of the comparative analysis of the effect of Ayurvedic treatment based on vatarakta and asthimajjagata vata samprapti pathways on the clinico-radiological and biochemical parameters in patients of non-traumatic osteonecrosis of femoral head (ONFH)
研究概览
简要总结
RESEARCH QUESTION:
Do Ayurvedic treatment regimens based on Vatarakta and Asthimajjagata vata samprapti pathways have any differential effect on the clinico-radiological and biochemical parameters in patients of non-traumatic osteo- necrosis of femoral head (ONFH)?
HYPOTHESIS:The size, shape and volume of the involved area of femoral head will recede on CT and MRI evaluation and clinical and biochemical parameters will improve more in Vatarakta group as compared to Asthimajjagata vata group in patients of non-traumatic osteo-necrosis of femoral head (ONFH) following the Ayurvedic treatment based on these two samprapti pathways.
NULL HYPOTHESIS:(H0)The size, shape and volume of the involved area of femoral head as measured on CT and MRI and clinical and biochemical parameters will remain unchanged irrespective of the Ayurvedic treatment based on Vatarakta and Asthimajjagata vata samprapti pathways in patients of non-traumatic osteo-necrosis of femoral head (ONFH).
GAP IN THE KNOWLEDGE:To the best of our understanding, the clinico-radiological and biochemical evaluation of the effect of the Ayurvedic treatment based on Vatarakta and Asthimajjagata vata samprapti pathways in patients of non-traumatic osteo-necrosis of femoral head (ONFH) has not been studied in Ayurveda literature so far.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- None
入排标准
- 年龄范围
- 20.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •As per ICD-11 classification, Osteonecrosis of Femoral head belongs to Cluster code No. FB81.0&XA96S5 2)MRI Diagnosed cases of Osteonecrosis of Femoral head up to Steinberg Stage V will be included into the study 3)Patients suffering from Osteonecrosis of Femoral head in the age group of 20-60 years, irrespective of their gender, caste, religion, or socioeconomic status.
排除标准
- •Femoral neck fracture 2)Femoral neck stress fracture 3)Hip dislocation.
- •Surgically intervened cases 5)Hip Tendonitis and Bursitis 6)Uncontrolled diabetes mellitus 7)TB and Malignancy.
- •Cardiac disease 9)Pregnancy.
结局指标
主要结局
Documentation of the comparative analysis of the effect of Ayurvedic treatment based on vatarakta and asthimajjagata vata samprapti pathways on the clinico-radiological and biochemical parameters in patients of non-traumatic osteonecrosis of femoral head (ONFH)
时间窗: 1st day | 50th day | 80th day
次要结局
- 1)Quantification of the pre and post treatment extent of osteonecrosis of the femoral head based on the size, shape and volume of the involved area on CT and MRI scans.(2)Quantification of the pre and post treatment extent of osteonecrosis of the femoral head based on the modified Kerboul combined necrotic angle of the involved area on MRI scans.)
研究者
Dr Birupakshya Sahu
All India Institute of Ayurveda