| CTRI Number |
CTRI/2017/08/009576 [Registered on: 31/08/2017] Trial Registered Retrospectively |
| Last Modified On: |
02/08/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical research to study the effect of Sirunerunjil kudineer on KALLADAIPPU(urinary stones) |
|
Scientific Title of Study
|
A prospective open labeled randomized clinical trial on "Kalladaippu" (Urolithiasis) with evaluation of trial drug "Siru Nerunjil kudineer" |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
T Seethalakshmi |
| Designation |
PG student |
| Affiliation |
Government Siddha Medical college and hospital |
| Address |
PG II year OPnumber 10 Department of Pothu Maruthuvam Government Siddha Medical college and hospital Palayamkottai
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9688588793 |
| Fax |
|
| Email |
baboo1726@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr G Subash Chandran MD Siddha PhD |
| Designation |
Lecturer |
| Affiliation |
Government Siddha Medical college and hospital |
| Address |
Department of Pothu Maruthuvam Government Siddha Medical college and hospital Palayamkottai
7th Perumal North Mada street Palayamkottai
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9443358271 |
| Fax |
|
| Email |
siddhadrgs21@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
G Subash chandran |
| Designation |
MD Siddha PhD |
| Affiliation |
Government Siddha Medical college and hospital |
| Address |
7th Perumal North Mada street Palayamkottai
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9443358271 |
| Fax |
0462-2582010 |
| Email |
siddhadrgs21@gmail.com |
|
|
Source of Monetary or Material Support
|
| Library Government Siddha Medical college and hospital |
| OPD and IPD ofGovernment Siddha Medical college and hospital |
|
|
Primary Sponsor
|
| Name |
S Neelavathi |
| Address |
Principal Goverment Siddha Medical College and hospital Palayamkottai |
| 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 |
| T Seethalakshmi |
Government Siddha Medical college and hospital |
OP number 10 Department of Pothu Maruthuvam Government Siddha Medical college and hospital Palayamkottai
Tirunelveli
TAMIL NADU |
9688588793
baboo1726@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 |
KALLADAIPPU, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not applicable |
Not applicable |
| Intervention |
Siru nerunjil kudineer |
40ml bid orally for 30 days |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient with appropriate symptoms of renal colic pain nausea or vomiting haematuria oliguria dysuria excessive sweating Patient who are willing to sign consent form and undergo laboratory investigations |
|
| ExclusionCriteria |
| Details |
Pregnant and lactating women Diabetes mellitus Chronic appendicitis Pyelonephritis Cholecystitis Systemic hypertension Recurrent UTI Chronic kidney disease Bilateral obstructive uropathy |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Therapeutic efficacy of Siru nerunjil kudineer on KALLADAIPPU |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Evaluation of Siddha diagnostic parameters |
30 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)
|
02/08/2017 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The study is prospective open Labeled randomized phase II clinical trial to evaluate the therapeutic efficacy of trial drug Siru nerunjil kudineer 40ml Bd for 30 days on the 40 patients with KALLADAIPPU that will be conducted in Government Siddha Medical college and hospital Palayamkottai The primary outcome will be the therapeutic efficacy of trial drug Sirunerunjil kudineer The secondary outcome will be the evaluation of Siddha diagnostic parameters |