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CTRI Number  CTRI/2023/03/050945 [Registered on: 21/03/2023] Trial Registered Prospectively
Last Modified On: 01/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Management of kidney disease with ayurvedic treatment. 
Scientific Title of Study   A clinical study to evaluate the efficacy of Virechana karma and Punarnavadi Niruha Basti along with Shamana chikitsa in stage i and stage ii Chronic kidney disease - A continuous study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Kaushal D Patel 
Designation  Pg scholar 
Affiliation  J S Ayurved mahavidyalaya 
Address  Department of Panchkarma j s ayurved mahavidyalaya college road Nadiad Kheda GUJARAT 387001 India

Kheda
GUJARAT
387001
India 
Phone  7016292581  
Fax    
Email  patelkaushal6372@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prof Dr Kalapi B Patel 
Designation  Professor 
Affiliation  J S Ayurved mahavidyalaya 
Address  Department of Panchkarma j s ayurved mahavidyalaya college road Nadiad Kheda GUJARAT 387001 India

Kheda
GUJARAT
387001
India 
Phone  9428661664  
Fax    
Email  drkalapi@rediffmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Kaushal D Patel 
Designation  Pg scholar 
Affiliation  J S Ayurved mahavidyalaya 
Address  Department of Panchkarma j s ayurved mahavidyalaya college road Nadiad Kheda GUJARAT 387001 India

Kheda
GUJARAT
387001
India 
Phone  7016292581  
Fax    
Email  patelkaushal6372@gmail.com  
 
Source of Monetary or Material Support  
SUNDAR AYURVEDA TEACHING PHARMACY OF J S AYURVEDA MAHAVIDYALAYA NADIAD 
 
Primary Sponsor  
Name  J S AYURVED MAHAVIDYALAYA 
Address  J S AYURVED MAHAVIDYALAYA COLLEGE ROAD NADIAD 
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 Kaushal D Patel  P D PATEL AYURVEDA HOSPITAL  DEPARTMENT OF PANCHKARMA J S AYURVED MAHAVIDYALAYA COLLEGE ROAD NADIAD Kheda GUJARAT
Kheda
GUJARAT 		 7016292581

patelkaushal6372@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee for human research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:N182||Chronic kidney disease, stage 2 (mild). Ayurveda Condition: MUTRAVAHASROTOVIKARAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-virecana-karma, विरेचन-कर्म (Procedure Reference: charaka samhita kalpasthana adhyay 1, Procedure details: Snehapaan (oral intake of the gokshuradi ghrita) will be given for 3- 7days, followed by full body oil massage and steam for 2 day. On the day of virechana karma, virechana karma will be given after the full body oil massage with bala taila and steam. After the procedure, patient will have to follow the sansarjana krama (specially designed diet) for 2 days.))
(1) Medicine Name: Dindayala churna, Reference: anubhuta, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: od, Duration: 1 Days
(2) Medicine Name: Eranda taila, Reference: charaka samhita chikitsasthana adhyaya 28, Route: Oral, Dosage Form: Taila, Dose: 50(ml), Frequency: od, Duration: 1 Days
2Intervention ArmProcedure-bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म (Procedure Reference: charaka samhita siddhisthana 1, Procedure details: the procedure in which the medicines are introduced inside the body through the rectum.))
(1) Medicine Name: punarnavadi kwatha, Reference: B.R.Udararogadhikar adhyaya, 40/31-32, Route: Rectal, Dosage Form: Kwatha/Kashaya, Dose: 320(ml), Frequency: od, Duration: 4 Weeks
3Intervention ArmDrugClassical(1) Medicine Name: varunadi kvatha, Reference: astanga hridaya sutrasthana adhyaya 15, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 4 Weeks, anupAna/sahapAna: No, Additional Information: -
(2) Medicine Name: gokshuradi guggulu, Reference: sharangadhara samhita madhyamakhanda 7, Route: Oral, Dosage Form: Guggulu , Dose: 3(NA), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 4 Weeks, anupAna/sahapAna: Yes(details: ushnodaka), Additional Information: -
(3) Medicine Name: rasayana churna, Reference: astanga hridaya uttarsthana adhyaya 39, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 4 Weeks, anupAna/sahapAna: Yes(details: ushanodaka), Additional Information: -
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.PATIENTS HAVING SERUM CREATININE LEVEL BETWEEN 1.4 MG/DL TO 3.0 MG/DL
2.PATIENTS INDICATED FOR VIRECHANA KARMA AND BASTI KARMA 
 
ExclusionCriteria 
Details  1.FEMALE PATIENTS HAVING PREGNANCY, BREAST FEEDING OR POST-DELIVERY PERIOD 2.PATIENTS OF END STAGE KIDNEY DISEASE
3.PATIENTS WHO ARE ON DIALYSIS TREATMENT
4.PATIENTS WHO HAVING PREVIOUS HISTORY OF RENAL TRANSPLANTATION 5.PATIENTS OF HEPATO-RENAL INSUFFICIENCY OR RENAL INSUFFICIENCY DUE TO HAEMODYNEMIC CIRCULATORY DISORDERS AND CCF
6.PATIENTS WITH SOME SERIOUS ILLNESS LIKE CARDIO-VASCULAR DISEASES, PSYCHOLOGICAL DISORDERS, SERIOUS ACUTE ORGANIC DISEASES, SERIOUS CHRONIC CO-MORBIDITIES, LIVER DISORDERS OR METABOLIC DISORDERS ETC
7.PATIENTS WITH ANY BLEEDING DISORDERS
8.PATIENTS CONTRAINDICATED FOR VIRECHANA KARMA AND BASTI KARMA 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
PRIMARY OUTCOME WILL BE RELIEF IN SIGNS, SYMPTOMS AND ASSESSMENT WILL BE DONE WITH THE HELP OF CHANGES IN HB EGFR SERUM CREATININE BLOOD UREA SERUM ELECTROLYTES (SODIUM, POTASSIUM, CHLORIDE) SERUM CALCIUM SERUM PHOSPHATE URINE ROUTINE AND MICROSCOPIC.  38-42 DAYS 
 
Secondary Outcome  
Outcome  TimePoints 
SECONDARY OUTCOME WILL BE IMPROVEMENT IN THE KIDNEY FUNCTION OF THE PATIENTS  every 15 days up to 2 months 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
Final Enrollment numbers achieved (Total)= "20"
Final Enrollment numbers achieved (India)="20" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/05/2023 
Date of Study Completion (India) 30/06/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 THIS WILL BE SUBMITTED IN A FORM OF DISSERTATION AND MAY BE PUBLISHED IN ANY PEER REVIEW JOURNAL WITH PRIOR PERMISSION OF GUJARAT AYURVEDA UNIVERSITY.  
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  

The present study is a open labelled clinical study assessing the effectiveness of Ayurveda treatment for patients with chronic kidney disease (CKD) with serum creatinine levels between 1.4 mg/dL and 3.0 mg/dL. Conducted with 20 patients from the IPD of P. D. Patel Ayurveda Hospital, Nadiad, the study employed Shodhana Treatment (Virechana Karma and Niruha Basti) and specific oral formulations including Varunadi kwatha, Gokshuradiguggulu and Rasayana churna aimed at restoring Mutravaha Srotas functions and rejuvenating renal tissues. Findings showed significant improvements, with a marked reduction in symptoms such as edema and general weakness and an increase in kidney function markers, including eGFR and reduction in Serum creatinine, Blood urea and urine albumin . The study suggests that Ayurvedic treatments may decelerate CKD progression, potentially delaying the need for renal replacement therapy.

 
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