Add-on effect of Shatavaryadi Basti in comparison with Punarnavadi Basti in the management of chronic kidney disease: A randomized comparative clinical trial

Chronic kidney disease (CKD) is defined as the presence of kidney damage or an estimated glomerular filtration rate (eGFR) less than 60 ml/min/1.73 mt2, persisting for 3 months or more, irrespective of the cause. Chronic kidney disease (CKD) refers to a group of pathophysiologic conditions characterized by impaired kidney function and a persistent decline in glomerular filtration rate (GFR). The risk of CKD progression is directly related to both GFR and the level of albuminuria, which gives a CKD staging. Diabetes and hypertension account for more than two-thirds of CKD cases in Western countries, owing to the prevalence of lifestyle disease. Diabetes and hypertension now account for 40-60% of CKD cases in India.

Chronic kidney disease (CKD) is not clearly mentioned in Ayurveda classics, but dispersed fragment of disease can be traced in various chapters, under different heading. While mentioning the genesis of Vrukka (kidney) Sushrut in Sharir Sthan told that it is a Matruj Avayava and it is formed of Rakta and Meda Dhatus. Although there is no description of CKD in Ayurveda Classics as per disease of Mutravaha Srotas, but disease described as per the manifestation from Hetu, dosha, Dhatu Dushti, Lakshana, etc. Hence, CKD is the collaborative progression of Rasavaha, Raktavaha, Mamsavaha, Medovaha-SrotasDusti which reflects through Mutravaha Srotas including Ojas Dusti.

So that line of treatment should be focusing on the vitiation of tissue by Amavisha (Sr.Creatinine and Sr.Urea) by correcting Ojas Dusti, Jatharagni correction , Dhatu Samyata (metabolism) , Rejuvenation of deteriorated cells of Vrukka (Kidney) and remove the toxic substances raised in blood by increasing eGFR as well as break off the progression of disease one stage to another.

·       Primary objective

Reduction in values of KFT about 30% from baseline ((Sr Creatinine, Blood urea, Serum Uric acid level)

· Secondary objective

1. To improve the hemoglobin, Glomerular Filtration Rate (e-GFR) and reduction in Albuminuria level.
2. Conceptual understanding of CKD in Ayurveda*.*
3. Assessment of signs and symptoms of CKD.
4. Assessment of quality of life in CKD by-Kidney Disease Quality of Life Short Form (KDQOL-SFâ„¢)

**Total sample size= 84 (approx.)**So, 42 patients in each group

Groups: 2

Group A

Group B

|Ayurvedic Shamana medicines +

Punarnavadi Basti along with CKD specific diet and lifestyle modifications

Ayurvedic Shamana medicines +

Shatavaryadi Basti along with CKD specific diet and lifestyle modifications

ASSESSMENT CRITERIA

Subjective

•       Signs and symptoms of CKD will be Analyzed in BT, 15th, 30th, 45th, AT and FU.

•       Quality of life of patients. (KDQOL 36) will be Analyzed in BT, 30th, AT and FU days

Objective

•       Serum creatinine will be Analyzed in BT, 15th, 30th, 45th, AT and after 2-month FU.

•       Blood urea will be Analyzed in BT, 15th, 30th, 45th, AT and after 2-month FU.

•       Hemoglobin will be Analyzed in BT, 15th, 30th, 45th, AT after 2 month and FU.

•       Albuminuria will be Analyzed in BT, 15th, 30th, 45th, AT after 2 month and FU.

•       e-GFR will be Analyzed in BT, 30th, AT and after 2-month FU.

DURATION OF TRIAL

Total duration (clinical trial duration + Follow up duration) = 60+60=120 days.

Visit of patient during trial period on every BT (0), 15, 30, 45, AT (60th) and after every 15 days for two-month FU period (up to 120th day).

END POINTS

***Primary-***Reduction in biochemical parameters with signs and symptoms.

***Secondary-***Improvement in quality of life.