A Clinical Study of Candraprabha Vati with Kalabasti in Mutravaha Sroto Dushti w.s.r. to Chronic Kidney Disease (CKD) in the purview of Na Bastisamam Kincit Karma Marmaparipalanamasti

NEED OF STUDY

Chronic Kidney Disease is a medical condition in which the kidney fails adequately filter waste-products from the blood. New drug and therapeutics are emerging for the management of CKD but its prevalence is increasing at an alarming rate. Retarding the progression of renal failure is one of the most important tasks of the medical science as it not only involves the quality of life of patient but also delays the development of end stage renal disease. As per treatment aspect use of dialysis, transplantation cause financial burden to patient. As soon as screening and early detection of Chronic Kidney Disease are believed to produce better health outcomes as both patients and caregivers can actively use tools and knowledge to decelerate progression to end-stages and improve outcomes.

RESEARCH QUESTION

Is there any effect of Candraprabha vati with kala-basti in mutravaha sroto-dusti w.s.r to Chronic Kidney Disease (CKD) in the purview of “Na bastisamam kinchit karma marmaparipalanamasti”.

HYPOTHESIS Null Hypothesis (H0): There is no effect of Candraprabha vati with kala-basti in mutravaha sroto-dusti w.s.r to Chronic Kidney Disease (CKD) in the purview of – “Na bastisamam kinchit karma marmaparipalanamasti”.

Alternative Hypothesis (H1): There is effect of Candraprabha vati with kala-basti in mutravaha sroto-dusti w.s.r to Chronic Kidney Disease (CKD) in the purview of – “Na bastisamam kinchit karma marmaparipalanamasti”.

AIM To study the effect of Candraprabha vati with kala-basti in mutravaha-sroto-dusti w.s.r. to Chronic Kidney Disease (CKD) in the purview of – “Na bastisamam kinchit karma marmaparipalanamasti”.

OBJECTIVES Primary Objectives: To evaluate the principle “Na bastisamam kinchit karma marma paripalanamasti” in mutravaha-sroto-dusti w.s.r. to Chronic Kidney Disease (CKD). To find out the effect of Candraprabha vati with kala-basti of “sharakashadi niruha and Pitadarusiddha taila anuvasana" on the markers of kidney damage i.e. eGFR, Sr. Creatinine etc. in Chronic Kidney Disease (CKD).

Secondary Objectives: To find out the effect of Candraprabha vati with kala-basti of “sharakashadi niruha and Pitadarusiddha taila anuvasana" on clinical signs and symptoms of Chronic Kidney Disease (CKD) patients.

MATERIALS AND METHODS

Following materials and methods will be employed for conducting the present research work:

Study Design : Clinical trial

Study type**:** Interventional

Allocation: Single arm

Site of study**:Department of Samhita evam Maulik Siddhant, National Institute of Ayurveda, Jaipur.

Purpose**:** Treatment

Masking**:** Open label

Timing**:** Prospective

Number of groups**:** Single

Duration of study: 60 days

Sample size**:** 20

By using previous study results ( M.D -1.254 and S.D.- 1.73) at 95% confidence level and 80% power the estimated S.S is 20.

Diagnostic criteria

Albumin creatinine ratio > 30 mg/g

 Electrolyte abnormalities due to tubular disorders.

 Serum creatinine > 1.2 mg/dl

 Blood urea > 40 mg/dl

 Abnormalities detected by USG KUB (if necessary for confirmation or differential diagnosis)

 History of failure of kidney transplantation.

 Decrease eGFR (GFR < 60ml/min/1.73 m2)

Inclusion criteria:

Participants of either gender of aged 18-60 years

Patients having one or more markers of kidney damage i.e.

Patients of Serum creatinine level 1.2 to 6.5mg

Patients of Blood urea level 48 to 180 mg/dl

Patients with eGFR level > 45 ml/min/1.73m² and persistent (present for > 3 months)

Patients of Albuminuria with ACR level > 30 mg/g.

Patients having any clinical signs and symptoms of Chronic Kidney Disease.

Patients who are fit for basti treatment

Exclusion criteria:

Patients who are on dialysis treatment for more than one month period

Patients who are already under gone for renal transplantation.

Patients who have stage 4 & 5 Chronic Kidney Disease.

Patients with Haemoglobin (Hb) < 7gm/dl .

Female patients having pregnancy, breast feeding or post-delivery period.

Patients having some illness like cardio-vascular disease, mental disorders or any other serious illness.

TRIAL DRUG

Kala basti

sharakashadi niruha basti Pitadarusiddha anuvasana basti

Posology :

Dose**:**1020ml

**Dose form:**Basti dravya

Route of administration: Basti

Time of administration: Empty stomach

Duration: 06 days

Candraprabha vati

Posology:

Dose: 500 mg BD

Dose form: vati

Route of administration: Oral

Time of administration: Before meal

Duration of Therapy: 60 days

ASSESSMENT CRITERIA

Subjective Parameters

Breathlessness (swasa krcchata) Anorexia (Aruci) Oedema (sotha) Generalised Weakness (Daurbalya) Nausea/Vomiting (chardi) Urine analysis (atisrista / atibaddha mutra, abhiksna / alpalpa mutra, sashula mutra, bahala mutra)

Objectives parameters

Lab investigations

The following investigation will be done on 0th day,4th week and end of the trial. Following laboratory investigations will be performed for proper diagnosis and to rule out major pathological conditions:

RFT , e GFR , CBC , Urine analysis , Serum electrolyte . Blood sugar level

 Routine examination and assessment**:** The full details of history & physical examination of patient will be recorded. Clinical & physiological assessment will be done before treatment, during treatment & at the end of the treatment and results will be analysed with appropriate statistical tests.

STUDY OUTCOME

Primary Outcome:

Changes in Serum creatinine level, eGFR, Blood urea level, ACR level from baseline to at end of the trail.

Secondary Outcome:

Patient get relief from clinical sign and symptoms of CKD at end of treatment.

Changes in urine analysis at end of 8th week.

Changes in the other laboratory like Serum electrolytes, Hb, Blood sugar level etc at the end of treatment.