FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/05/087193 [Registered on: 20/05/2025] Trial Registered Prospectively
Last Modified On: 18/05/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Preventive 
Study Design  Single Arm Study 
Public Title of Study   Kalabasti and Candraprabha Vati in Chronic Kidney Disease A Traditional Approach 
Scientific Title of Study   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 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Maitri Dineshbhai Pandya 
Designation  Md scholar  
Affiliation  National institute of ayurveda 
Address  Room no.103,Ayurveda samhita evam siddhnata vibhag , National institute of ayurveda, Zorawar singh gate Amer road Jaipur

Jaipur
RAJASTHAN
302002
India 
Phone  09104972114  
Fax    
Email  maitripandya1441@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Abhijeet Kumbhar 
Designation  Assitant professor 
Affiliation  National institute of ayurveda 
Address  Ayurveda samhita evam siddhnata vibhag , National institute of ayurveda, Zorawar singh gate Amer road Jaipur

Jaipur
RAJASTHAN
302002
India 
Phone  9689237789  
Fax    
Email  jeetayu87@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Abhijeet Kumbhar 
Designation  Assitant professor 
Affiliation  National institute of ayurveda 
Address  Ayurveda samhita evam siddhnata vibhag , National institute of ayurveda, Zorawar singh gate Amer road Jaipur

Jaipur
RAJASTHAN
302002
India 
Phone  9689237789  
Fax    
Email  jeetayu87@gmail.com  
 
Source of Monetary or Material Support  
National Institute of Ayurveda, Jaipur 
 
Primary Sponsor  
Name  National Institute of Ayurveda, Jaipur 
Address  National Institute of Ayurveda Deemed to be University De novo Jorawar Singh Gate,Amer Road, Jaipur Rajasthan 302002 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Maitri Dineshbhai Pandya  National institute of ayurveda  Room no.103,Ayurveda samhita evam siddhnata vibhag , National institute of ayurveda, Zorawar singh gate Amer road Jaipur
Jaipur
RAJASTHAN 		 09104972114

maitripandya1441@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee National institute of ayurveda  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:N183||Chronic kidney disease, stage 3 (moderate). Ayurveda Condition: MUTRAVAHASROTODUSHTIH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म (Procedure Reference: charak samhita siddhi sthana , Procedure details: Niruha basti of 1020 ml in left lateral posiion)
(1) Medicine Name: chandraprabha vati, Reference: sharangadhar samhita , Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 500(mg), Frequency: bd, Duration: 60 Days
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Participants of either gender of aged 18-60 years
2.Patients having one or more markers of kidney damage i.e.
a.Patients of Serum creatinine level 1.2 to 6.5mg
b.Patients of Blood urea level 48 to 180 mg/dl
c.Patients with eGFR level more than 45 ml/min/1.73m² and persistent (present for more than then 3 months)
d.Patients of Albuminuria with ACR level moe than than 30 mg/g.
3.Patients having any clinical signs and symptoms of chronic kidney disease.
4.Patients who are fit for basti treatment
 
 
ExclusionCriteria 
Details  1.Patients who are on dialysis treatment for more than one month period
2.Patients who are already undergone for renal transplantation.
3.Patients who have stage 4 & 5 chronic kidney disease.
4.Patients with Haemoglobin (Hb) less than 7gm/dl
5.Female patients having pregnancy, breast feeding or post-delivery period.
6.Patients having some illness like cardio-vascular disease, mental disorders or any other serious illness.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Changes in Serum creatinine level, eGFR, Blood urea level, ACR level from baseline to at end of the trail.  60 days 
 
Secondary Outcome  
Outcome  TimePoints 
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
 		 60 days 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   01/07/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

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:1020 ml

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.


 
Close