| CTRI Number |
CTRI/2020/11/028822 [Registered on: 03/11/2020] Trial Registered Prospectively |
| Last Modified On: |
31/10/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical effect to study the effect of the drug Pavazha Silasathu parpam in patients having uncomplicated cystitis ( Azhal Neerchurukku) |
|
Scientific Title of Study
|
Phase II non randomized open clinical study of Siddha medicine Pavazha Silasathu parpam for Azhal Neerchurukku Churruku ( uncomplicated cystitis) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nill |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Maha Sundari Sudha M |
| Designation |
PG Scholar |
| Affiliation |
Government Siddha Medical college |
| Address |
Post Graduate Department of General medicine Government Siddha Medical college 600106 Arumbakkam Chennai Tamilnadu
Post Graduate Department of General medicine Government Siddha Medical college 600106 Arumbakkam Chennai
Chennai
TAMIL NADU
600106
India |
| Phone |
9150723084 |
| Fax |
|
| Email |
sundarim075@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Chitra U |
| Designation |
Lecturer |
| Affiliation |
Government Siddha Medical college |
| Address |
Post Graduate Department of General medicine Government Siddha Medical college 600106 Arumbakkam Chennai Tamilnadu
Post Graduate Department of General medicine Government Siddha Medical college 600106 Arumbakkam Chennai
Chennai
TAMIL NADU
600106
India |
| Phone |
9445716802 |
| Fax |
|
| Email |
mmsankar2000@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Maha Sundari Sudha M |
| Designation |
PG scholor |
| Affiliation |
Government Siddha Medical college |
| Address |
Post Graduate Department of General medicine Government Siddha Medical college 600106 Arumbakkam Chennai Tamilnadu
Post Graduate Department of General medicine Government Siddha Medical college 600106 Arumbakkam Chennai Tamilnadu
Chennai
TAMIL NADU
600106
India |
| Phone |
9150723084 |
| Fax |
|
| Email |
sundarim075@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Siddha Medical college Arumbakkam Chennai 600106 |
|
|
Primary Sponsor
|
| Name |
Government Siddha Medical college |
| Address |
Government Siddha Medical college Arumbakkam Chennai Tamilnadu 600106 |
| 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 Maha Sundari Sudha |
Arignar Anna Government hospital of Indian |
Room no 1 Ground floor Department Arignar Anna Government hospital of Indian medicine Arumbakkam Chennai Tamilnadu 600106
Chennai
TAMIL NADU |
9150723084
sundarim075@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: A488||Other specified bacterial diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
| Intervention |
Pavazha Silasathu parpam |
130mg of Pavazha Silasathu parpam is administered orally twice a day with butter for 15 days |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
Hematuria
Dysuria
Frequency of micturition
Oliguria
Patients having supra pubic pain
Foul / cloudy smelling urine |
|
| ExclusionCriteria |
| Details |
Pregnant/ Lactating women
Pyelonephritis
Catheterized patients
Vaginitis
STD
Prostitis
Kidney stones |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary outcome is assessed by reduction of
dysuria
Frequency of micturition
suprapubic pain
Disappearance of bacteria in culture
|
Primary outcome is assessed by after four weeks of administration of the medicine
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Disappearance of bacteria in culture |
15 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)
|
10/11/2020 |
| 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) |
Not Yet Recruiting |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a single Non randomized open clinical trial to study the safety and efficacy of Siddha drug Pavazha Silasathu parpam .The trial is given 130mg twice a day with butter for 15 days. Clinical trial is conducted after conducting pre clinical toxicity study . The trial drug Pavazha Silasathu parpam is mentioned in Kannusamy parambarai vaithiyam. During the trial all the trial related data are recorded and documented . After the completion of the trial all the data will be analyzed statistically |