| CTRI Number |
CTRI/2023/07/054789 [Registered on: 05/07/2023] Trial Registered Prospectively |
| Last Modified On: |
16/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Clinical trial on Arugampul veer kudeneer in the management of Kalladaippu (Urolithiasis) |
|
Scientific Title of Study
|
A PROSPECTIVE OPEN LABELLED, SINGLE ARM, NON RANDOMISED SINGLE CENTRIC, PHASE II CLINICAL TRIAL
ON ARUGAMPUL VER KUDENEER IN THE MANAGEMENT OF KALLADAIPPU NOI(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 S Prema |
| Designation |
PG Scholar |
| Affiliation |
Government Siddha Medical College and Hospita |
| Address |
Department of Pothu Maruthuvam Government Siddha Medical College and Hospital Palayamkottai
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9790269215 |
| Fax |
|
| Email |
drprema1982@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Justus Antony MDS PhD |
| Designation |
Reder |
| Affiliation |
Government Siddha Medical College and Hospital |
| Address |
Department of Pothu Maruthuvam OPno10 Government Siddha Medical College Hospital Palayamkottai
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9443090849 |
| Fax |
|
| Email |
justusantony71@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr Manoharan MDS PhD |
| Designation |
professor and HOD |
| Affiliation |
Government Siddha Medical College ana Hospital |
| Address |
Department of Pothu Maruthuvam OPno10 Government Siddha Medical College and Hospital Palayamkottai
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9443886700 |
| Fax |
|
| Email |
drmanoharan25@gmail.com |
|
|
Source of Monetary or Material Support
|
| OPD and IPD facilities and Central Library of Government Siddha Medical College and Hospital |
|
|
Primary Sponsor
|
| Name |
Government Siddha Medical College and Hospital |
| Address |
Government Siddha Medical College and Hospital Palayamkottai Tamil nadu |
| Type of Sponsor |
Government 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 S Prema |
Government Siddha Medical College and Hospital |
PG Department of pothu Maruthuvam OPno10 Government Siddha Medical College and Hospital Palayamkottai
Tirunelveli
TAMIL NADU |
9790269215
drprema1982@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N209||Urinary calculus, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
ARUGAMPUL VEER KUDENEER |
Dosage: 30-60 ml
Frequency: twice a day
Duration: 45 days |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient with the symptoms of Renal colicky pain
Loin to groin
pain
Nausea
Vomiting and sweating
Hematuria
Oliguria
Dysuria
|
|
| ExclusionCriteria |
| Details |
Chronic Appendicitis
Cholecystitis
Pelvic inflammatory disease
Chronic Renal Failure
Bilateral obstructive uropathy |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Reduction in severity of Renal colicky pain,
Reduction of Nausea/vomiting
Reduction of Hematuria, Polyuria, Dysuria and
Oliguria.
The kidney stone is expelled to come out as
such or be disintegrated and mixed with urine
will be ensured. |
45 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The secondary outcome is reduction in size of
the kidney stone in USG abdomen and pelvis. |
45days |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
21/07/2023 |
| Date of Study Completion (India) |
05/07/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
This study is a Prospective Open Labelled, Single arm, Non-Randomized, Single centric, Phase II clinical trial onARUGAMPUL VEER KUDENEER in the management of KALLADAIPPU NOI(UROLITHIASIS) The trial drug will be administered orally at the dose of 30_60ml twice a day 45days along with as butteradjuvant in 40 patients. The trial period of 12 months will becarried out in Government Siddha Medical College and Hospital, Palayamkottai, Tirunelveli 627002 , Tamil nadu. The primary outcome will be the evaluation of therapeutic efficacy of the trial drug ARUGAMPUL VEER KUDENEER. The secondary outcome will be the evaluation of Siddha diagnostic parameters,assessment of safety profile of trial drug, assessment of pharmacological and biochemical parameters of the trial drug. In case of any adverse events(AE) is noticed and it will be referred to pharmacovigilance department of SCRI. Further management of patients Will be given in OPD facility. |