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CTRI Number  CTRI/2026/03/105644 [Registered on: 09/03/2026] Trial Registered Prospectively
Last Modified On: 06/03/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Study the effect of ayurvedic medicine in old kidney disease 
Scientific Title of Study   A Randomised Prospective clinical study to evaluate the effect of sinhasyadi vati with standard treatment protocol of ckd in management of vatbasti mutraghat with respect to chronic kidney disease stage 2 
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 Santosh Bankati Mundhe 
Designation  PG Scholar Kayachikitsa Dept. 
Affiliation  Ayurved Seva Sangh Ayurved Mahavidyala, Ganeshwadi ,Panchavati ,Nashik- 03 
Address  OPD No 13 Kayachikitsa OPD

Nashik
MAHARASHTRA
422003
India 
Phone  8767271896  
Fax    
Email  santoshmunde651996@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Harish garge 
Designation  Assosciate Professor and Guide 
Affiliation  Ayurved Seva Sangh Ayurved Mahavidyala, Ganeshwadi ,Panchavati ,Nashik- 03 
Address  OPD No 13 Kayachikitsa OPD

Nashik
MAHARASHTRA
422003
India 
Phone  09405366160  
Fax    
Email  drhgarge@rediffmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Harish garge 
Designation  Assosciate Professor and Guide 
Affiliation  Ayurved Seva Sangh Ayurved Mahavidyala, Ganeshwadi ,Panchavati ,Nashik- 03 
Address  OPD No 13 Kayachikitsa OPD

Nashik
MAHARASHTRA
422003
India 
Phone  09405366160  
Fax    
Email  drhgarge@rediffmail.com  
 
Source of Monetary or Material Support  
Ayurved Seva Sangh Ayurved Mahavidyalaya Ganeshwadi Panchavati Nashik 422003 Maharashtra India 
 
Primary Sponsor  
Name  Ayurved Seva Sangh Ayurved Mahavidyalaya Nashik 
Address  Ayurved Seva Sangh Ayurved Mahavidyalaya Ganeshwadi Panchavati Nashik 422003 
Type of Sponsor  Other [Govt aided Institution] 
 
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 Santosh Mundhe  Arogyashala Rugnalaya  OPD No 13 Kayachikitsa OPD
Nashik
MAHARASHTRA 
8767271896

santoshmunde651996@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethical committee, Ayurved Seva Sangh Ayurved mahavidyalaya, Nashik   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: MUTRAGHATAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: sinhasyadi vati, Reference: Bharat Bhaishajya Ratnavali Vatrakta chikitsa 27/590, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1000(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: -warm water), Additional Information: -
2Comparator Arm (Non Ayurveda)-tablet sodabicarbRoute Oral, Dosage Form Tablet Dose 500mg BID Adhobhakt Duration 90 Days
 
Inclusion Criteria  
Age From  35.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  history of reduction of kidney function must be present over three months serum creatinine level above one point four mgperdl and below four point six mgperdl serum urea level above fourty mgperdl and below one hundred one mgperdl patient having hb level greater than eight gmperdl gfr thirty to ninety mlperminper one point seven three meter square bun blood urea nitrogen above eighteen point sixmgperdl and below fourty six point eightmgperdl 
 
ExclusionCriteria 
Details  blood urea more than 100mgperdl and below 41mgperdl serum creatinine level above 4.5 mgperdl and below 1.5mgperdl bun blood urea nitrogen above 46.7mgperdl and below 18.7mgperdl GFR less than 30mlperminper1.73meter square and less than 90mlperminper1.73meter square patients under frequent dialysis uncontrolled diabetes mellitus
malignant hypertension grade III prostate 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Increase in EGFR level  2 Weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Decrease in serum creatinine levels  2 weeks 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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/ Phase 3 
Date of First Enrollment (India)   23/03/2026 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  
chronic kidney disease  is a syndrome characterized by progressive and irreversible deterioration of renal function due to slow destruction of renal parenchymal eventually terminating in death when sufficient numbers of nephrons have been damaged over a period of months or years. It is also called as chronic renal failure  It is an internationally recognized public health problem affecting 5 10percent of world population generally signs and symptoms of renal disease are often non-specific the signs and symptoms may appear at the stage of irreversible damage which include nausea vomiting anorexia sleep problems changes in urine output decreased mental sharpness muscle twitches cramps hiccups anasarca persistent itching shortness of breath fatigue and weakness etc often it is diagnosed as a result of high blood pressure or diabetes and those with a blood relative with renal disorders It is considered as long term form of kidney disease and is differentiated from acute kidney disease in that the reduction in kidney function must be present for over 3 months2
according to ayurveda it can be correlated with Mutraghata belonging to pathology of mutravaha srotasa. mutraghata is one of the most common and distressing disease among the group of urinary disorder.For easy to understand the 12 types of Mutraghata are being classified into three categories The first category is based on the neurogenic disturbances of the bladder and the types that can be included under this are  Vatakundalika Vatabasti and Mutrajathara The second category with the symptomatology of obstructed flow of urine increased frequency of urination sense of incomplete voiding etc includes Bastikundalika Mutragranthi Mutrotsarga and Ashteela types. The third category is termed as Others where the types included are Mutrakshaya Anuria Ushnavata Hematuria Mutroukasada Abnormal colorization of urine Vidvighata faecum passed per uretherum and Mutrashukra Retrograde flow of semen Mutraghata is a condition in consequence with some kind of Obstructive Uropathy either mechanical or functional related either to upper or lower urinary tract resulting in to either partial or complete retention of urine as well as Oliguria or Anuria Normal functions of Mutravaha srotasa urinary system is regulated by Apana vayu one among the five types of Vayu.Any derangement in Apana vayu leads to the pathology of the urinary system. So the treatment principle is to correct the vitiated Apana Vayu thereby attaining the normal physiology of the urinary system. This controls the symptoms of the Mutravaha Srotasa. Acharya Charaka has mentioned eight types in Sutrasthana Further, in Siddhisthana thirteen types of Basti rogas have been described under the heading of Mutradosha. Acharya Sushruta has explained twelve types of Mutraghata in Uttaratantra but in spite of Bastikundalika and Vidvighata varieties as described in Charaka. Sushruta has described the two type of Mutroukasada i.e Pittaja and Kaphaja while Charaka and Vagbhata described only one type i.e. Mutroukasada6. Ashtanga Sangraha and Ashtanga Hridaya, includes Mutrakricchra and Ashmari rogas. Acharya Vagbhata has categorized the diseases of Mutravaha Srotasa into two types i.e. Mutra Atipravrittijanya and Mutra Apravrittijanya Rogas. Mutra vegavarodha is mentioned as one of the most important causative factor in Mutraghata. It is but clear that the Apana vayu is responsible for normal voiding of urine, if deranged by voluntary suppression of urge of micturition which results in Mutraghata
 
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