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CTRI Number  CTRI/2023/05/053091 [Registered on: 24/05/2023] Trial Registered Prospectively
Last Modified On: 23/05/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   An open labelled randomised comparative clinical and in vitro study to evaluate the effect of Pashanabhedadi kashaya ghana capsule and Pashanabheda kashaya ghana capsule in the management of Mootrashmari vis-à-vis Nephrolithiasis 
Scientific Title of Study   An open labelled randomised comparative clinical and invitro study to evaluate the effect of Pashanabhedadi kashaya ghana capsule and Pashanabheda kashaya ghana capsule in the management of Mootrashmari vis-à-vis Nephrolithiasis 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr SHAILESH Y 
Designation  ASSISTANT PROFESSOR 
Affiliation  SDMCA KUTHPADY UDUPI, KARNATAKA 
Address  PG AND PhD STUDIES IN THE DEPARTMENT OF KAYACHIKITSA SDMCA Kuthpady, Udupi, Karnataka 574118
NEJAR NEAR ASHWATHKATTE POST SANTHEKATTE UDUPI, KARNATAKA 576105
Udupi
KARNATAKA
574118
India 
Phone  9481522560  
Fax    
Email  drshayayu@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr SHRILATHA KAMATH T 
Designation  PROFESSOR AND HEAD 
Affiliation  SDMCA KUTHPADY UDUPI, KARNATAKA 
Address  PG AND PhD STUDIES IN THE DEPARTMENT OF KAYACHIKITSA SDMCA Kuthpady, Udupi, Karnataka

Udupi
KARNATAKA
574118
India 
Phone  9964899638  
Fax    
Email  shri9503@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr SHAILESH Y 
Designation  ASSISTANT PROFESSOR 
Affiliation  SDMCA KUTHPADY UDUPI, KARNATAKA 
Address  PG AND PhD STUDIES IN THE DEPARTMENT OF KAYACHIKITSA SDMCA Kuthpady, Udupi, Karnataka
NEJAR NEAR ASHWATHKATTE POST SANTHEKATTE UDUPI KARNATAKA 574105
Udupi
KARNATAKA
574118
India 
Phone  9481522560  
Fax    
Email  drshayayu@gmail.com  
 
Source of Monetary or Material Support  
SDM AYURVEDA PHARMACY KUTHPADY UDUPI KARNATAKA 
 
Primary Sponsor  
Name  NIL 
Address  NIL 
Type of Sponsor  Other [SELF FUNDED] 
 
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 SHAILESH Y  SRI DHARMASTHALA MANJUNATHESHWARA COLLEGE OF AYURVEDA KUTHPADY UDUPI KARNATAKA   PG AND PhD STUDIES IN THE DEPARTMENT OF KAYACHIKITSA KUTHPADY UDUPI KARNATAKA 574118
Udupi
KARNATAKA 
08202520332

drshayayu@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICAL CLEARANCE COMMITTEE HUMAN  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N200||Calculus of kidney,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: PASHANABHEDA KASHAYA GHANA CAPSULE, Reference: SHARANGHADHARA, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 4(g), Frequency: tds, Bhaishajya Kal: Pragbhakta, Duration: 75 Days, anupAna/sahapAna: Yes(details: LUKE WARM WATER), Additional Information: PASHANABHEDA GHANA KASHAYA FILLED TO VEG CAPSULE EACH CAPSULES CONTAIN 4GRMS OF GHANA KASHAYA
2Comparator ArmDrugClassical(1) Medicine Name: PASHANABHEDADI KASHAYA GHNA CAPSULE, Reference: YOGARATNAKARA, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 4(g), Frequency: tds, Bhaishajya Kal: Pragbhakta, Duration: 75 Days, anupAna/sahapAna: Yes(details: LUKE WARM WATER), Additional Information: PASHANABHEDADI KASHAYA GHANA FILLED IN VEG CAPSULES. EACH CAPSULES CONTAINS 4GMS OF GHANA KASHAYA
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Diagnosed cases of Mootrashmari vis-à-vis Nephrolithiasis as per the diagnostic criteria
Patients with solitary or multiple renal calculi with size less than or equal to 10 mile meter size
Participants are willing to provide informed consent
 
 
ExclusionCriteria 
Details  Patients with associated obstructive pathologies like BPH urethral stricture and congenital anatomical abnormalities
Renal calculi in associated with uretreric bladder or uretral calculi
During the phase of Renal colic and Ureteric colic
Patients with severe Hydronephrosis
Pregnant women and lactating mothers
Systemic diseases which interfere with disease process and present clinical trial
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   On-site computer system 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
EXPULTION OF KIDNEY STONES  AT 45TH DAY 
 
Secondary Outcome  
Outcome  TimePoints 
IMPROVEMENT OF QUALITY OF LIFE
based on a questionnaire 
AT 45TH DAY 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   01/06/2023 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  01/06/2023 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="5"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NONE YET 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   Background of the study:
Nephrolithiasis or calculi formation in kidneys, is a common problem worldwide,  with prevalence of 7% in the adults and > 30% recurrence  rate within 10years. The incidence  of Nephrolithiasis is globally increasing with an estimated prevalence ranging up to 15%. During lifetime, approximately 7% of women and 13% of men will develop a kidney stone. In Indian population, about 12% of them are expected to have urinary stones and  out of which 50% may end up loss of kidney functions. Invasive therapies for removal of calculi such as ESWL ( Extra corporeal shock wave  Lithotripsy). PCNL (Percutaneous nephrolithotripsy), Basketing therapy, Pylolithotomy are commonly for the management of Nephrolithiasis . Features of Nephrolithiasis are closely similar to the disease Mootrashmari in the Ayurveda parlance and majority of the pathology in both the condition are similar.
Purpose of the study:
In spite of technological advances in the field of  medicine and surgery conservative therapy still continues to a solution for all reversible ailments. Even though invasive therapies are one of the  alternatives used commonly for the management of Nephrolithiasis , however these therapies  have their  own disadvantages and complications. Kshara, kashaya  and churna  yogas  are frequently used  forms of medicines, palatability is major challenges. Considering the magnitude of the condition at present, there is a need of widely acceptable, evidence based, cost effective, easily available, simple, safe and single drug for Nephrolithiasis.
 
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