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CTRI Number  CTRI/2022/05/042799 [Registered on: 25/05/2022] Trial Registered Prospectively
Last Modified On: 24/05/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Study conducted to see the effect of Kataka Beeja Churna and Gokshura Churna in Kidney stones 
Scientific Title of Study   A Randomized Comparative Clinical Study to evaluate the effect of Kataka Beeja Churna and Gokshura Churna in the management of Mutrashmari with special reference to Renal Calculi 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Chaitra B Naduvinamani 
Designation  MS PG Scholar Shalyatantra  
Affiliation  BVVS Ayurveda Medical College and Hospital Bagalkot 
Address  Department of PG Studies in Shalyatantra BVVS Ayurveda Medical College and Hospital Bagalkot BVVS Campus Bagalkot

Bagalkot
KARNATAKA
587101
India 
Phone  9481727634  
Fax    
Email  naduvinamanichaitra@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr M M Salimath 
Designation  Prinicipal and Professor 
Affiliation  BVVS Ayurveda Medical College and Hospital Bagalkot 
Address  Department of PG Studies in Shalyatantra BVVS Ayurveda Medical College and Hospital Bagalkot BVVS Campus Bagalkot

Bagalkot
KARNATAKA
587101
India 
Phone  9845010950  
Fax    
Email  dr_mahantesh@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr M M Salimath 
Designation  Prinicipal and Professor 
Affiliation  BVVS Ayurveda Medical College and Hospital Bagalkot 
Address  Department of PG Studies in Shalyatantra BVVS Ayurveda Medical College and Hospital Bagalkot BVVS Campus Bagalkot

Bagalkot
KARNATAKA
587101
India 
Phone  9845010950  
Fax    
Email  dr_mahantesh@yahoo.com  
 
Source of Monetary or Material Support  
BVVS Ayurveda Medical College and Hospital Bagalkot, Karnataka - 587101 
 
Primary Sponsor  
Name  BVVS Ayurveda Medical College and Hospital Bagalkot 
Address  BVVS Ayurveda Medical College and Hospital Bagalkot, BVVS Campus Bagalkot - 587101 Karnataka  
Type of Sponsor  Private 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 Chaitra B Naduvinamani  BVVS Ayurved Medical College and Hospital  Shalyatantra OPD Room no 03 BVVS Ayurveda Medical College and Hospital Bagalkot.BVVS Campus
Bagalkot
KARNATAKA 
9481727634

naduvinamanichaitra@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC BVVS Ayurved Medical College and Hospital, Bagalkot, Karnataka  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. Ayurveda Condition: MUTRAVAHASROTODUSHTIH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Kataka Beeja Churna, Reference: Dhanvantari nighantu Chandanadi Varga, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -Sukhoshna jala), Additional Information: -
2Comparator ArmDrugClassical(1) Medicine Name: Gokshura Churna, Reference: Sushruta Samhita Chikitsa Stana 7th chapter 29th shloka , Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -Sukhoshna jala), Additional Information: -
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1)Patients between age group of 20-60 years of either sex.
2)Diagnosed patients of Mutrashmari presenting with signs and symptoms of Mutrashmari(renal calculi).
3)Symptomatic and asymptomatic Patients with renal calculi of size 3mm to 10mm in kidney as reported by USG Abdomen and Pelvis
 
 
ExclusionCriteria 
Details  1)Patient suffering with systemic disorders like Ischemic Heart Disease, tuberculosis, diabetes mellitus, hypertension etc
2)Impacted stone.
3)Pregnant and lactating women
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1)Pain
2)Tenderness over renal angle
3)Dysuria
4)Size of Renal calculi 
4 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
1)Hematuria
2)Pyuria
 
4 weeks 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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 
Date of First Enrollment (India)   28/05/2022 
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 Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
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

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - Any purpose.

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

  6. For how long will this data be available start date provided 28-05-2022 and end date provided 28-05-2030?
    Response - Immediately following publication. No end date.

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

Ashmari is one of the disorders of Mutravaha Srotas and it is included in Astamahagada.

The word ‘Ashma’ means ‘stone’ and ‘Ari’ means ‘enemy’. The formation of stone which cause great pain and suffering to the body like an enemy is called Ashmari.

Renal Calculi are one of the most painful and common disorders of urinary tract, which are solid crystals that form from dissolved minerals in urine, caused by both environmental and metabolic problems.

Acharya Sushruta explains Lakshanas of Ashmari as pain in Nabhi (umbilical), Basti (bladder), Sevani (perinealraphe), and Mehana (penis), Mutradharana (obstruction in flow of urine), Sarudhiramutra (haematuria), Mutravikirana (scattering of urine), Gomedakaprakasha (passing of urine like Gomeda), Sasikata (with gravels) and Visrujati (turbid).

The lifetime risk of kidney stone is estimated to be between 5% and 10% with reoccurrence rate as high as 50%. Renal calculi occurs in people of all parts of the world with lower time risk of 3-15% in the west 25% in Asia and 20% in India. Renal calculi are quite common and usually affects people who are between 20-60 years of age, they affect male more than female. It is estimated that renal colic affects about 10-20% of male and 3-5% female.

In India, Kidney stone Disease is prevalent, with an expectancy of 12% in total population reported to be prone to urinary stone. Of this 12%, 50% of the population is affected by renal damage, which even leads to a loss of kidneys.

 Acharya Sushruta has described various medicines and surgery. Medical treatment has been advised to be undertaken in the early stage of the disease. Indication for the surgical management has mentioned along with the note of caution regarding complication.

In the context of Ashmari Chikitsa, Acharya Sushruta has advised that surgery to be undertaken only on failure of conservative treatment and when death becomes inevitable if not treated surgically.

Acharya Sushruta explained the use of Gokshura with Madhu and Aviksheera as Anupana in Ashmari Chikitsa.Gokshura has properties like Ashmarihara and Basti Shodana.

  Kataka explained in Dhanvantari Nighantu Chandanadi Varga is taken for the study. Acharya while explaining the properties of Kataka states, it is Vaariprasadana, Chedaniya Vishagna and Muootrashmarihara. By going through the individual Guna Karma of Kataka it is said to be Tridoshahara.

The study will be carried out to evaluate the effect of Kataka Beeja Churna and Gokshura Churna in Mutrashmari.

 
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