| CTRI Number |
CTRI/2020/02/023632 [Registered on: 27/02/2020] Trial Registered Prospectively |
| Last Modified On: |
22/06/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Clinical study of Karasoodasathu Parpam in the management of Kalladaippu Noi (Urolithiasis) |
|
Scientific Title of Study
|
A Prospective Open labelled non randomized phase II Clinical trial on Karasoodasathu Parpam in 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 |
K Soundarya |
| Designation |
PG Scholar |
| Affiliation |
Government Siddha Medical College and Hospital |
| Address |
IIyear PG Scholar Department of Pothu Maruthuvam Government Siddha Medical College and Hospital Palayamkottai
Tirunelveli
TAMIL NADU
627 002
India |
| Phone |
9442534699 |
| Fax |
|
| Email |
soundaryabalabsms@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr G Subashchandran MDs |
| Designation |
Lecturer II |
| Affiliation |
Government Siddha Medical College and Hospital |
| Address |
Department of Pothu Maruthuvam Government Siddha Medical College and Hospital Palayamkottai
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9443358271 |
| Fax |
|
| Email |
siddhadrgs21@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr G Subashchandran MDs |
| Designation |
Lecturer II |
| Affiliation |
Government Siddha Medical College and Hospital |
| Address |
Department of Pothu Maruthuvam Government Siddha Medical College and Hospital Palayamkottai
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9443358271 |
| Fax |
|
| Email |
siddhadrgs21@gmail.com |
|
|
Source of Monetary or Material Support
|
| IPD and OPD facilities and central library of Government Siddha Medical College and Hospital |
|
|
Primary Sponsor
|
| Name |
Government Siddha Medical College and Hospital |
| Address |
Palayamkottai Tirunelveli Tamilnadu 627002 |
| 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 |
| K Soundarya |
Government Siddha Medical College and Hospital |
Department of Pothu Maruthuvam Government Siddha Medical College and Hospital Palayamkottai Tirunelveli 627002
Tirunelveli
TAMIL NADU |
9442534699
soundaryabalabsms@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 |
Karasoodasathu Parpam |
2.5-5 mgKgBWTwice a dayAf for 45 days with Honey |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Renal colicky pain from loin to groin
2.Nausea and Vomiting
3.Haemeturia
4.Oliguria
5.Dysuria
6.Patients who are willing to undergo radiological Investigations and give blood for laboratory investigations. |
|
| ExclusionCriteria |
| Details |
1.Chronic Appendicitis
2.Cholecystitis
3.Pyelonephritis
4.Recurrent UTI
5.Diabetes mellitus
6.Metabolic disorders like Hyperthyroidism,Hyperparathyroidism
7.Pelvic inflammatory disease
8.Chronic Renal Failure |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Reduction in Severity of renal colicky pain,Nausea,Vomiting,Haematuria,Dysuria,Oliguria
2.Reduction in size of the kidney stone in USG Abdomen and pelvis(In selective patients) |
45 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Evaluation of pharmacological ,Biochemical and Phytochemical analysis of trial drug.
2.Determination of safety profile of trial drug
3.Evaluation of additional effects and Siddha parameters changes in Kalladaippu noi. |
45 days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
02/03/2020 |
| Date of Study Completion (India) |
12/04/2021 |
| 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)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The study is a Prospective Open Labelled Phase II non-randomized clinical study to evaluate the therapeutic efficacy of Karasoodasathu Parpam in the management of Kalladaippu Noi(Urolithiasis).The trial drug will be administered at the dose of 2.5 - 5mgKgBWTwice a day|AF for 45 days in 60 patients. The trial period of 12 months will be carrying out in Government Siddha Medical College and Hospital ,Palayamkottai,Tirunelveli,Tamilnadu.The primary outcome will be the evaluation of therapeutic efficacy of trial drug Karasoodasathu parpam. 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 trial drug. |