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CTRI Number  CTRI/2025/12/098848 [Registered on: 10/12/2025] Trial Registered Prospectively
Last Modified On: 09/12/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Clinical study For the Chronic Kidney Disease 
Scientific Title of Study   Randomised Clinical Study To Evaluate The Efficacy Of Punarnavadi Ksheera Basti And Of Punarnava-Gokshuradi Ksheerabasti In Subject Of Chronic Kidney Disease(CKD). 
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 Upanishad 
Designation  2nd Year M.D. Student In Panchakarma 
Affiliation  Ayurveda Mahavidyalaya And Hospital Hubli 
Address  Ayurveda Mahavidyalaya and Hospital, Department of Panchakarma, Room No.2, Heggeri Extension, Old Hubli, Hubli

Dharwad
KARNATAKA
580024
India 
Phone  9886781085  
Fax    
Email  uppupadhye@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Vasant C Patil 
Designation  Professor  
Affiliation  Ayurveda Mahavidyalaya And Hospital Hubli 
Address  Ayurveda Mahavidyalaya and Hospital, Department of Panchakarma, Room No.2, Heggeri Extension, Old Hubli, Hubli

Dharwad
KARNATAKA
580024
India 
Phone  9902749144  
Fax    
Email  ayurvasant@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Upanishad 
Designation  2nd Year M.D. Student In Panchakarma 
Affiliation  Ayurveda Mahavidyalaya And Hospital Hubli 
Address  Ayurveda Mahavidyalaya and Hospital, Department of Panchakarma, Room No.2, Heggeri Extension, Old Hubli, Hubli

Dharwad
KARNATAKA
580024
India 
Phone  9886781085  
Fax    
Email  uppupadhye@gmail.com  
 
Source of Monetary or Material Support  
Ayurveda Mahavidyalaya and Hospital, Hubli, District:- Dharwad, Pin:- 580024, India 
 
Primary Sponsor  
Name  Ayurveda Mahavidyalaya and Hospital Hubli 
Address  Ayurveda Mahavidyalaya And Hospital, Heggeri Extension, Old hubli, Hubli 580024 
Type of Sponsor  Government medical college 
 
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 Upanishad   Ayurveda Mahavidyala And Hospital, Heggeri Extension, Old Hubli, Hubli: 580024.  Panchakarma, OPD NO. 2
Dharwad
KARNATAKA 		 9886781085

uppupadhye@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethical Committe Of Ayurveda Mahavidyalaya  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: MUTRAGHATAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmProcedure-bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म (Procedure Reference: Charakasamhita Siddhisthana 3rd Chapter 65-68th verse, Procedure details: Guda or Saindhava (according to group) is powdered well in a Khalwa. Then Madhu is added while triturating until it’s a homogenous mixture. After that, Sneha is added & triturating is continued till a uniform consistency is achieved. Then Kalka which is prepared with above said ingredients (according to selected group of Subjects) is added to the ongoing Basti preparation. After that the Ksheera Paka which is prepared (according to selected group of Subjects) is poured continuous, slow and in the streamline manner until it becomes a uniform mixture and administrated as Sukhoshna. once daily for 8 days then 15 days of Oushada sevana and then again 8 days of Basti then 15 days of Oushada Sevana. )
(1) Medicine Name: Punarnavadi Kashaya, Reference: Sahasrayogam , Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 20(ml), Frequency: bd, Duration: 30 Days
2Comparator ArmProcedure-bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म (Procedure Reference: Bhaishajya Ratnavali 42nd Chapter 13th verse, Procedure details: Guda or Saindhava (according to group) is powdered well in a Khalwa. Then Madhu is added while triturating until it’s a homogenous mixture. After that, Sneha is added & triturating is continued till a uniform consistency is achieved. Then Kalka which is prepared with above said ingredients (according to selected group of Subjects) is added to the ongoing Basti preparation. After that the Ksheera Paka which is prepared (according to selected group of Subjects) is poured continuous, slow and in the streamline manner until it becomes a uniform mixture and administrated as Sukhoshna. once daily for 8 days then 15 days of Oushada sevana and then again 8 days of Basti then 15 days of Oushada Sevana. )
(1) Medicine Name: Punarnavadi Kashaya , Reference: Sahasrayogam, Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 20(ml), Frequency: bd, Duration: 30 Days
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Subjects who are fulfilling the objective criteria.
2. Subjects age between 18-70yrs, of either sex.
3. Subjects who are fit for Niruha Basti Karma.
4. Subjects with classical symptoms of CKD having clinical features of oedema, pruritis, generalized weakness, nausea, oliguria, loss of appetite, breathlessness, muscle cramps.
5. Diagnosed cases of CKD with GFR lies between 30-90 mL/min/1.73m2 and not on dialysis.
6. Subjects with Albuminuria(30-300mg) for more than 3 months.
7. Subjects with adequate Blood pressure control.
8. Subjects with adequate glycemic control.
 
 
ExclusionCriteria 
Details  1. Subjects who are having Ama Lakshana.
2. Subjects of congenital renal diseases, Polycystic Kidney diseases, congenital nephrotic syndrome or any other congenital disorders.
3. Subjects having severe Agnimandya.
4. Pregnant women, lactating mother or post-partum subjects.
5. Subjects who are on dialysis, operated for renal transplantation.
6. Subjects with serious illness and on treatment, like cardiovascular diseases, acute/chronic mental disorders, serious organic diseases, comorbid Subjects, hepato-pancreatic diseases.
7. 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.
8. History of malabsorption or any intestinal related pathology.
9. Under treatment or operated of Ca of rectum, kidneys, intestines or Subjects with any kind of malignancy.
10. 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.
11. Subjects with history of any kind of pathologic conditions which hampers the study.

 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Improved Kidney Functions.  55 days 
 
Secondary Outcome  
Outcome  TimePoints 
1. Improved GFR
2. Reduction in oedema.
3. Reduction in Pruritis.
4. Oliguria.
5. Pallor.
6. Anorexia.
7. Nausea.
8. Generalised weakness.
9. Haematuria 		 55 Days
 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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 3 
Date of First Enrollment (India)   20/12/2025 
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [uppupadhye@gmail.com].

  6. For how long will this data be available start date provided 26-05-2026 and end date provided 01-01-2050?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

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 retention of Kleda in Shareera resulting in CKD.

By analyzing the above Samprapti, the management of the CKD should be aiming at removing the pacification of Vata and associated Doshas, Srotoprasadana, Mutrala and also should act as Rasayana, helping in regeneration 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.

 

 
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