Assess The Efficacy of Prakriti Related Customized Ayurveda Treatment Module In The Management of Asthimajjagata Vata (Avascular Necrosis of Femoral Head)- An Exploratory Study
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Reduction in pain.
研究概览
简要总结
Avascular necrosis (AVN) is defined as cellular death of bone components due to interruption of the blood supply; the bone structures then collapse, resulting in pain, loss of joint function and long-term joint damage. Avascular necrosis of femoral head in the North Indian people is a disease of young individuals with male predominance. Steroid intake is most commonly observed in these patients followed by idiopathic, chronic alcohol consumption, and trauma Studies have attributed the disease process to the combined effect of genetic predisposition, metabolic factors and local factors affecting blood supply such as vascular damage, increased interosseous pressure and mechanical stress. This results in bone ischaemia.
Treatment modalities such as Deepana-Pachana, Snehpana, Virechana Karma, Patra pinda swedana & Basti karma Are Effective in the management of Asthimajjagata Vata.
Here in this study an attempt is made to find out the efficacy of customized treatment protocol as explain in Samhitas
OBJECTIVES OF THE RESEARCH PROJECT:
PRIMARY: 1) To determine the efficacy of Customized Ayurveda Treatment Module when given for a period of 63 days for reducing pain in Asthi-Majjagata Vata(Avascular necrosis of femoral Head) patients of 16-65yrs of age.
SECONDARY: 1) Subgroup Analysis would be Done Based on Prakriti. 2) To improve the range of motion in patients of Asthi-Majjagata Vata(Avascular necrosis of femoral head). 3) To Determine the change in Quality of Life in patients with Avascular necrosis of femoral head.
Study Type: Interventional Sub Type: Exploratory Timing: Prospective Masking: Open Label Grouping: Triple Arm Interventional Method: Parallel Study Site: Patients attending the Panchakarma OPD & IPD of AIIA fulfilling diagnostic criteria will be recruited
Total duration of Study- 63 days
Total duration of Procedure-33 days
Shamana aushadhi- 15 days
Follow up duration- 15 days
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 16.00 Year(s) 至 65.00 Year(s)（—）
入选标准
- •1.Patients who are fit to undergo Snehpana, Virechana & Basti Karma 2.Chronicity: Upto 5 years.
- •3.Age between 16yrs to 65yrs.
- •4.Gender: Irrespectively both genders will be considered for the study 5.Diagnosed cases of Avascular necrosis of femoral head with MRI findings.
- •6.Socio-economic status: All.
排除标准
- •Known cases of uncontrolled Diabetes, Pulmonary tuberculosis other systemic illnesses and pregnant women.
结局指标
主要结局
Reduction in pain.
时间窗: (Day-0)(Day-33)(Day-48)(Day-63)
次要结局
- Increase in Range of Motion(To determine change in Quality of life)