CTRI Number |
CTRI/2024/01/061098 [Registered on: 03/01/2024] Trial Registered Prospectively |
Last Modified On: |
01/01/2024 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Ayurveda Other (Specify) |
Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
|
kidney stone treatment with kokilaksha Panchag kshar |
Scientific Title of Study
|
Randomized open controlled clinical trial to evaluate the efficacy of Kokilaksha panchang kshar in Mootrashmari with special reference to urolithiasis |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr.Vaibhav Sadashiv Magar |
Designation |
Associate Professor |
Affiliation |
Yashwant Ayurvedic college post graduation training and research centre kodoli |
Address |
Yashwant Ayurvedic College PGT And Research centre kodoli
Shalyatantra department OPD NO 4 Yashwant Ayurvedic College Post Graduation Traing And Research centre kodoli
Shalyatantra department Kolhapur MAHARASHTRA 416114 India |
Phone |
8600667796 |
Fax |
-- |
Email |
dr.vaibhav83magar@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr T Srinivas |
Designation |
Professor and HOD |
Affiliation |
Yashwant Ayurvedic college post graduation training and research centre kodoli |
Address |
Yashwant Ayurvedic College Post Graduation Training and Research Centre Kodoli
Shalyatantra Department Yashwant Ayurvedic College Post Graduation Training and Research Centre Kodoli
Shalyatantra Department Kolhapur MAHARASHTRA 416114 India |
Phone |
9503147698 |
Fax |
-- |
Email |
drsrinivast@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Vaibhav Sadashiv Magar |
Designation |
Associate Professor |
Affiliation |
Yashwant Ayurvedic college post graduation training and research centre kodoli |
Address |
Yashwant Ayurvedic College PGT And RC Kodoli
Shalyatantra Department OPD NO 4 Yashwant Ayurvedic College PGT And RC Kodoli
Shalyatantra Department OPD NO 4 Kolhapur MAHARASHTRA 416114 India |
Phone |
8600667796 |
Fax |
-- |
Email |
dr.vaibhav83magar@gmail.com |
|
Source of Monetary or Material Support
|
Natural from Kokilaksha herb. |
|
Primary Sponsor
|
Name |
Dr Vaibhav Sadashiv Magar |
Address |
Yashwant Ayurvedic college PGT and RC Kodoli dist kolhapur |
Type of Sponsor |
Other [self] |
|
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 |
DrVaibhav sadashiv magar |
Yashwant Ayurvedic college post graduation and Research centre |
A/P Kodoli Tahsil Panhala Kolhapur Shalyatantra OPD no 4 Kolhapur MAHARASHTRA |
8600667796
dr.vaibhav83magar@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethical commitee |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition:N22||Calculus of urinary tract in diseases classified elsewhere. Ayurveda Condition: Urinary Calculus,Unspecified, (2) ICD-10 Condition:N22||Calculus of urinary tract in diseases classified elsewhere. Ayurveda Condition: MUTRAVAHASROTOVIKARAH, |
|
Intervention / Comparator Agent
|
sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
1)Calculus present in kidney,Bladder,Ureter single,bilateral
2)USG showing calculus of size equal to or less than 8mm in size
3)Subject showing sign and symptoms of mootrashmari.
4)Recurrent and non recurrent history of stone. |
|
ExclusionCriteria |
Details |
1)Calculus size more than 8mm
2)Subject require immediate surgical management.
3)Patient having renal failure/impairement
4)Gross Haematuria./Impacted stone
5)Shukrashmari
6)Patient having any systemic diseases. |
|
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 |
Decrease in stone size in mm according to USG. |
After 28 days. Decrease in stone size in mm will be recorded according to USG. |
|
Secondary Outcome
|
Outcome |
TimePoints |
Decrease in symptoms like pain,burnig micturation,dysuria,haematuria |
28 days |
|
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 2/ Phase 3 |
Date of First Enrollment (India)
|
11/01/2024 |
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
|
N/A |
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 (Others) -
- What additional supporting information will be shared?
Response - None of the above
- 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 - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) -
- For how long will this data be available start date provided 15-10-2023 and end date provided 15-05-2025?
Response (Others) -
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - no
|
Brief Summary
|
This study is Randomized open controlled clinical study to evaluate the efficacy of Kokilaksha panchang kshar in Mootrashmari w.s.r to Urolithiasis.Study will be carried out in shalyatantra department of Yashwant ayurvedic college and Hospital kodoli,kolhapur.The observation would be drawn on the basis of symptoms after treatment given. |