A clinical study to evaluate the comparative effect of customised Basti and classical Basti in the management of chronic kidney disease (CKD): An exploratory 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 the values of KFT (Sr Creatinine, Blood urea, Serum Uric acid level) and to improve estimated Glomerular Filtration Rate (e-GFR)

Secondary objective

1. To improve Hb%.

2. To reduce Albuminuria.

3. To improvement in signs and symptoms of CKD

4. Assessment of quality of life by-Kidney Disease Quality of Life Short Form

(KDQOL-SF)

5. To analyze electrolyte imbalance.

Group A

Customized Basti

Group B

Classical Basti

|·       Ayurvedic Shamana chikitsa

Customised daily Shatavaryadi for 15 days

CKD specific diet and lifestyle modifications

Ayurvedic Shamana chikitsa

Basti treatment in Kaala Basti*

Krama of Shatavaryadi Basti

CKD specific diet and lifestyle modifications

ASSESSMENT CRITERIA

Subjective

Signs and symptoms of CKD at BT, AT, after 2-monthsFU.

Quality of life of patients at BT, AT, after 2-monthsFU.

Objective

•       KFT assessed at BT, 15th, AT, after 2-month FU.

•       e-GFR assessed at BT, AT, after 2-month FU.

•       Sr Electrolyte assessed at BT, 15th, AT, after 2-month FU.

•       Hemoglobin assessed at BT, 15th, AT, after 2-month FU.

•       Albuminuria assessed at BT, 15th, after AT, 2-month FU.

DURATION OF TRIAL

·       Total duration of trial

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

·       Visit of patient during trial period on every 0, 15, 30, 45, 60th and after every 15 days up to for follow-up 120th days.

END POINTS

•       Primary

•       Reduction in biochemical parameters with signs and symptoms.

•       Secondary

•       Improvement in quality of life.

SAMPLE SIZE: Total 50 Patients, 25 in each group (exploratory trial)