| 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
|
|
|
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
|
|
|
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
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (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: - | | 2 | Comparator Arm (Non Ayurveda) | | - | tablet sodabicarb | Route 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 |