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
|
|
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
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition:N200||Calculus of kidney. Ayurveda Condition: MUTRAVAHASROTODUSHTIH, |
|
Intervention / Comparator Agent
|
sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | 1 | Intervention Arm | Drug | Classical | | (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: - | 2 | Comparator Arm | Drug | Classical | | (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
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [naduvinamanichaitra@gmailcom].
- 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.
- 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. |