A Single-Arm Clinical Study To Evaluate The Efficacy Of Ayurveda Treatment Module On The Basis Of Prakriti In The Management Of Asthimajjagata Vata (Avascular Necrosis of Femoral Head)
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 入组人数
- 63
- 试验地点
- 1
- 主要终点
- Reduction In Pain (VAS Score)
研究概览
简要总结
In this study, a clinical trial is conducted to evaluate the efficacy of the Ayurveda treatment module on the basis of prakriti in the management of Asthi-majjagata Vata (Avascular Necrosis ), which has been practiced before in a previous study conducted on the Panchakarma department of the All India Institute of Ayurveda. This treatment module will be used to manage Asthi-majjagata Vata patients based on their prakriti (Vata, Pitta, and Kapha ). 63 is the sample size, and the treatment period is 96 days, including 48 days of follow-up.
Participants from AIIA’s Panchakarma OPD and IPD who fulfill the diagnostic criteria will be recruited. Ayurveda treatment module followed by Deepana-pachan with Rasna churna in Vata prakriti, Guduchi Churna in Pitta Prakriti, Shunthi Churna in Kapha Prakriti, Sarvang abhyanga with bala taila in Vata Prakriti, with Ksheera bala taila in Pitta Prakriti, with Brihat Saindhav taila in Kapha Prakriti. Sarvang Bashpa Swedana with Dashmoola Kashaya. Snehpana with Panchatikta guggulu gahrita. Virechana with Trivritta Avaleha and erand tail, with Trivritta Avaleha and Ksheera, with Trivritta Avaleha and Triphla Kwath. Basti in Vata Prakriti manjishthadi nirooha basti and bala tail anuvasana basti, in Pitta Prakriti manjishthadi Ksheera basti and Ksheera bala tail anuvasan basti, and in Kapha Prakriti manjishthadi Kshaar basti and Sahacharadi taila anuvasan basti. Patra Pinda swedana with nirgundi taila in Vata prakriti, with Ksheerabala taila in Pitta Prakriti, with Sahacharadi Taila in Kapha Prakriti, and Shaman chikitsa with trayodashanga guggulu, Panchatikta guggulu gahrita, and dashmoola Kwath in Vata Prakriti, with Kaishore guggulu, Brihat manjishthadi kwath, and Panchatikta guggulu gahrita in Pitta Prakriti, with lakshadi guggulu, Sahacharadi Kwath, and Panchatikta guggulu gahrita in Kapha Prakriti of participants.
And the efficacy of the treatment will be assessed by the parameters VAS Scale, Oxford Hip Score, Harris Hip Score, and SF-12 after Deepana-pachana, after basti, after shaman chikitsa, and last after follow-up. An ELISA Test for assessing RANKL Biomarker will be done before and after treatment. An MRI will be performed after treatment to assess any radiological changes before and after treatment.
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
- 18.00 Year(s) 至 65.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients who are fit to undergo Panchkarma procedures as Snehpana, Virechana & Basti Karma.
- •Age between 18 to 65 years.
- •All cases of AVN of stage I to stage IV according to FICAT and ARLET classification would be considered.
- •Chronicity up to 5 yrs
- •Confirmed diagnosis of Avascular Necrosis of the femoral head with MRI Findings.
- •Both genders, male and female, will be considered for the Study.
排除标准
- •Known cases of uncontrolled diabetes and hypertension, Tuberculosis, or severe illness
- •Pregnant or lactating mother.
- •Patients unfit for Snehpaan, Swedan, Virechana, and Basti Karma.
- •Psychiatric or cognitive impairment.
结局指标
主要结局
Reduction In Pain (VAS Score)
时间窗: at baseline, after 4 week, after 8 week, after 12 week.
Increase in Range of movement
时间窗: at baseline, after 4 week, after 8 week, after 12 week.
次要结局
- Changes in serum level of RANKL BIOMARKER &(Improvement in Degenerative changes in MRI Findings.)
研究者
Dr Vikas Kumar Gothwal
All India Institute of Ayurveda
