Randomised Clinical Study To Evaluate The Efficacy Of Punarnavadi Ksheera Basti And Of Punarnava-Gokshuradi Ksheerabasti In Subject Of Chronic Kidney Disease(CKD).
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Improved Kidney Functions.
研究概览
简要总结
Ayurveda being science of life*,* with holistic approach to health, known to be a complete medical system that comprised of physical, psychological, philosophical, ethical and spiritual health. In Ayurveda, Panchakarma remains the most important aspect for treating the diseases, among them Basti is the Pradhana, almost all the Acharyas consider Basti as Ardhachikitsa advocated as best and quickest way to provide strength and immunity even to children and old people.
Basti being Ardhachikitsa it becomes important to study the effect of Basti in the management of diseases which are causing human life a misery, among them chronic kidney disease (CKD) plays an important role.
CKD is a condition characterized by a gradual loss of kidney function over time. According to The National Kidney Foundation- Kidney Disease Outcomes Quality Initiative (NKF-KDOQI) CKD is defined by structural or functional abnormalities of the kidney with decreased GFR, manifested by either pathological abnormalities or other markers of kidney damage, including abnormalities in the composition of blood or urine, abnormalities in the imaging test; or the presence of GFR less than 60ml/min/1.73m2 for more than three months with or without other signs of kidney damage.1
The prevalence of CKD in Subjects with HTN, DM & vascular disease is substantially higher. More than 25% of the population aged over 75 years have an eGFR of <60ml/min/1.73m2, mostly stage 3A CKD, which in this context typically reflects an increased cardiovascular risk burden. Many primary renal diseases, however, are more common in the elderly, so investigation is warranted for those with declining renal function, hematuria or proteinuria on dip stick. 2
If the pathology for CKD is not controlled then it may lead to End Stage Renal Disease in which the treatments include Dialysis and Renal Transplantation etc. which are complicated, tedious, costly, and of high risk. Therefore, there is an urgent need of therapy which can prevent from going to dialysis and renal transplantation.
In Ayurveda we don’t find the direct reference for CKD but we get the scattered references in Mutraghata. Acharya Charaka considered Mutravaha srotomula as Basti and Vankshana,3 whereas Acharya Sushruta considered Mutravaha srotomula as Basti and Medhra,4 Basti has been considered as common entity by both the Acharyas. It is said to be derived from Prasada Bhaga of Rakta & Medas5, which is predominant in Pritvi & Aap Mahabhootas. So, In Ayurveda, kidney can be correlated with Vrikka.
While discussing about Mutra Karma in Ayurveda, it has been told that Mutra is one among the Trimala, which helps to evacuate the Kleda (waste products) from the body.6 And this evacuation is done by *Apana Vata.*7
Due to Nidana Sevana8 and in the presence of etiological factors, Avarodhana to Apana Vata takes place in Mutravaha Srotas and Basti9*,* this leads to Apana Vata Prakopa, this Prakupita Vata does the Karshana10 of Mutra and Vrikka, this leads for the failure of Vrikka to evacuate the Mutra through Mutravaha Srotas. This causes retentionof Kleda in Shareera resulting in CKD.
By analyzing the above Samprapti, the management of the CKD should be aiming at removing thepacification of Vata and associated Doshas, Srotoprasadana, Mutrala and also shouldact as Rasayana, helping inregeneration of renal parenchyma.
To treat the Vata Dosha associated with Kapha and Pitta; Basti is the Pradhana Chikitsa11 as explained in the classics. The primary site of action of Basti is Pakwashaya which is the Pradhana Sthana for Vata Dosha where urine formation takes place12.
So, the Basti Karma is selected for the procedure, which is used in treatment for Vata, Pitta, Kapha, Samsarga and Sannipataja Rogas as per Maharshi Sushruta13.
Punarnava can act as Rasayana14 for the dying cells and help to revive these cells of the body. Gokshura has the diuretic property which is helpful in CKD by improving the urine output which results in improving kidney function15. Hence Punarnava and Gokshura are selected as a main drug for the Ksheera Basti.
So, the current work undertaken to study the efficacy of Punarnavadi Ksheera Basti of Charaka Siddhisthana16 and modified Punarnava-Gokshuradi Ksheera Basti17 of Bhaishajya Ratnavali in the management of chronic kidney disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects who are fulfilling the objective criteria.
- •Subjects age between 18-70yrs, of either sex.
- •Subjects who are fit for Niruha Basti Karma.
- •Subjects with classical symptoms of CKD having clinical features of oedema, pruritis, generalized weakness, nausea, oliguria, loss of appetite, breathlessness, muscle cramps.
- •Diagnosed cases of CKD with GFR lies between 30-90 mL/min/1.73m2 and not on dialysis.
- •Subjects with Albuminuria(30-300mg) for more than 3 months.
- •Subjects with adequate Blood pressure control.
- •Subjects with adequate glycemic control.
排除标准
- •Subjects who are having Ama Lakshana.
- •Subjects of congenital renal diseases, Polycystic Kidney diseases, congenital nephrotic syndrome or any other congenital disorders.
- •Subjects having severe Agnimandya.
- •Pregnant women, lactating mother or post-partum subjects.
- •Subjects who are on dialysis, operated for renal transplantation.
- •Subjects with serious illness and on treatment, like cardiovascular diseases, acute/chronic mental disorders, serious organic diseases, comorbid Subjects, hepato-pancreatic diseases.
- •Evidence of active infection on the day of pretrial investigation with temperature more than 38 C or WBC more than or equal to 13,000 cells/µL.
- •History of malabsorption or any intestinal related pathology.
- •Under treatment or operated of Ca of rectum, kidneys, intestines or Subjects with any kind of malignancy.
- •Subjects who are on treatment for epileptic or any neurological pathologies, Subjects who are on anti-TB medications, or steroids for more than 6 months.
- •Subjects with history of any kind of pathologic conditions which hampers the study.
结局指标
主要结局
Improved Kidney Functions.
时间窗: 55 days
次要结局
- 1. Improved GFR(2. Reduction in oedema.)
研究者
Dr Upanishad
Ayurveda Mahavidyalaya And Hospital Hubli