| CTRI Number |
CTRI/2024/02/062444 [Registered on: 08/02/2024] Trial Registered Prospectively |
| Last Modified On: |
06/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Siddha |
| Study Design |
Other |
|
Public Title of Study
|
Padikara Chunnam for Urolithiasis |
|
Scientific Title of Study
|
Phase II non randomized open clinical evaluation of Siddha medicine Padikara Chunnam for the management of Vatha Kalladaippu (UROLITHIASIS) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
A Kamaraj |
| Designation |
PG Scholar |
| Affiliation |
Government siddha Medical College |
| Address |
Post Graduate Department Of Pothu Maruthuvam Government Siddha Medical College Arumbakkam,Chennai-106
Chennai
TAMIL NADU
600106
India
Chennai
TAMIL NADU
600106
India |
| Phone |
7299201607 |
| Fax |
|
| Email |
akamaraj2711sp@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr ANBU N |
| Designation |
HOD and Professor |
| Affiliation |
Government siddha Medical College |
| Address |
Post Graduate Department Of Pothu Maruthuvam Government Siddha Medical College Arumbakkam,Chennai-106
TAMIL NADU
600106
India
Chennai
TAMIL NADU
600106
India |
| Phone |
9443279412 |
| Fax |
|
| Email |
nanbu.sumi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr ANBU N |
| Designation |
HOD and Professor |
| Affiliation |
Government siddha Medical College |
| Address |
Post Graduate Department of Pothu Maruthuvam Siddha Medical College Arumbakkam Chennai-106
TAMIL NADU
600106
India
Chennai
TAMIL NADU
600106
India |
| Phone |
9443279412 |
| Fax |
|
| Email |
nanbu.sumi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Siddha Medical College Arumbakkam Chennai-106 |
|
|
Primary Sponsor
|
| Name |
DR Kamaraj A |
| Address |
Post Graduate Department Of Pothu Maruthuvam Government Siddha Medical College Arumbakkam,Chennai-106 |
| Type of Sponsor |
Other [Government Siddha Medical College , Chennai, Arumbakkam] |
|
|
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 A Kamaraj |
Government Siddha Medical College |
Room no:S1, Department of PG Pothu Maruthuvam,Arumbakkam, Chennai -106
Chennai
TAMIL NADU |
7299201607
akamaraj2711sp@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instituitional Ethics Committee,Gsmc,chennai |
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, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not applicable |
Not applicable |
| Intervention |
PADIKARA CHUNNAM |
This Siddha herbal drug will begiven as 390mg to 650 mg , BD dose with neeraagaram, for 21 days for the management of
Urolithiasis |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
LOWER ABDOMINAL PAIN FLANK PAIN BURNING MICTURITION STONE SIZE 4 TO 10 MM HAEMATURIA |
|
| ExclusionCriteria |
| Details |
Hydronephrosis, pregnancy,stag horn calculus, Calculi associated with serum creatinine level |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in stone size and evaluation of stone |
21 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduce clinical symptoms like Lower Abdominal pain,flank pain , Haematuria, burning micturition |
21 days |
|
|
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)
|
18/02/2024 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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
|
Urinary calculi are formed by deposits of polycrystalline aggregates composed of varied amounts of crystalloid and organic matrix. They can vary in size and may be found anywhere in the urinary tract from the kidney to the bladder. Stone formation requires saturated urine dependent upon urine pH, ionic strength, solute concentration. The aim of the study is the management of VATHA KALLADAIPPU (UROLITHIASIS) with the Siddha medicine PADIKAARA CHUNNAM To study the therapeutic ef bacy and safety profle of PADIKAARA CHUNNAM in the treatment of VATHA Kalladaippu.Since the study medicine consist of lithotriptic action, the outcome will be assesed by reduction in the clinical symptoms and evaquation of the stone. After completion of detailed pre clinical and clinical trial the action of PADIKARA CHUNNAM on VATHA KALLADAIPPU will be furnished. |