| CTRI Number |
CTRI/2017/04/008435 [Registered on: 27/04/2017] Trial Registered Retrospectively |
| Last Modified On: |
26/04/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Clinical Trial to study the effect of the Drug Karpoora silasathu parpam in patients with kidney stones |
|
Scientific Title of Study
|
A clinical study on kalladaippu (Urolithiasis) with the evaluation of siddha drug " Karpoora silasathu parpam " |
| 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 Sarathkumar |
| Designation |
Pg scholar |
| Affiliation |
Govt.siddha medical college,chennai 106 |
| Address |
Dept.of Pothu Maruthuvam,Govt.siddha medical college,chennai,tamilnadu-600106,india
Chennai
TAMIL NADU
600106
India |
| Phone |
|
| Fax |
|
| Email |
sarathkumar197@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Drkkanakavalli |
| Designation |
Professor |
| Affiliation |
Govt.siddha medical college |
| Address |
Room No : 2 Division : Siddha Department :General Medicine
Arignar Anna Government Hospital of Indian Medicine & Homeopathy, Arumbakkam, Chennai
Chennai
TAMIL NADU
600106
India |
| Phone |
|
| Fax |
|
| Email |
dr.kkanakavalli@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr S Sarathkumar |
| Designation |
PG scholar |
| Affiliation |
Govt.siddha medical college |
| Address |
Room No : 2 Division : Siddha Department :General Medicine Arignar Anna Government Hospital of Indian Medicine & Homeopathy, Arumbakkam, Chennai
Chennai
TAMIL NADU
600106
India |
| Phone |
|
| Fax |
|
| Email |
sarathkumar197@gmail.com |
|
|
Source of Monetary or Material Support
|
| Govt.Siddha Medical college, Arumbakkam, Chennai |
|
|
Primary Sponsor
|
| Name |
Dr S Sarathkumar |
| Address |
Room No : 2 Division : Siddha Department :General Medicine
Arignar Anna Government Hospital of Indian Medicine & Homeopathy, Arumbakkam, Chennai |
| 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 Sarathkumar |
Arignar Anna Hospital.,Govt.Siddha Medical College |
Room No : 2 Division : Siddha Department :General Medicine
Arignar Anna Government Hospital of Indian Medicine & Homeopathy, Arumbakkam, Chennai
Chennai
TAMIL NADU |
8939885695
sarathkumar197@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 (Urolithiasis), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Karpoora Silasthu Parpam |
130 mg with Ilaneer,48 days |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.History of Urolithiasis (with USG-Whole Abdomen reports)
2.Pain the Flank
3.Burning Micturition
4.Nausea
5.Vomiting
6.Oliguria
7.Dysuria
8.Haematuria
9.Fever
10.Stone size-4 to 10mm |
|
| ExclusionCriteria |
| Details |
1.Hydro nephrosis
2.Stag horn calculus
3.Calculi associated with elevated serum creatinine level
4.Calculi in pregnancy |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mainly assessed by reduction of clinical symptoms and comparing before and after treatment |
48 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Any toxicity of the drug |
14 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)
|
03/11/2016 |
| 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
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is a single arm open clinical trial to study the safety and efficacy of Siddha trial drug Karpoora Kilasathu parpam. The trial drug is given 100 milli grams twice a day for 48 days. Clinical trial is conducted after conducting Preclinical toxicity study. The trial drug Karpoora silasathu parpam is mentioned in Agasthiyar chendhooram 300. During the trial all the study related data will be recorded and documented. After the completion of trial all the data will be analysed statistically. |