| CTRI Number |
CTRI/2023/03/050696 [Registered on: 14/03/2023] Trial Registered Prospectively |
| Last Modified On: |
11/03/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Evaluating therapeutic efficacy of VASANTHAKUSUMAKARAM MATHIRAI for PITHA NEER CHURUKU(Urinary Tract Infection) |
|
Scientific Title of Study
|
Evaluating therapeutic efficacy of Siddha formulation VASANTHA KUSUMAKARAM MATHIRAI in the management of PITHA NEER CHURUKU (Urinary tract infection) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr A Surya Dr D Anandhalakshmi Dr A Pavithra |
| Designation |
PG Scholar |
| Affiliation |
National Institute of Siddha |
| Address |
Room no 7/8 Department of Maruthuvam National Institute of Siddha Tambaram Sanatorium Chennai 47
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
8072897366 |
| Fax |
22381314 |
| Email |
pavithrapaviam8@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr H Nalini sofia |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Siddha |
| Address |
Room no 7/8 Department of Maruthuvam National Institute of Siddha Tambaram Sanatorium Chennai 47
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
8939899363 |
| Fax |
22381314 |
| Email |
dr.h.nalinisofia@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr A Surya Dr D Anandhalakshmi Dr A Pavithra |
| Designation |
PG Scholar |
| Affiliation |
National Institute of Sidhha |
| Address |
Room no 7/8 Department of Maruthuvam National Institute of Siddha Tambaram Sanatorium Chennai 47
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
8072897366 |
| Fax |
22381314 |
| Email |
pavithrapaviam8@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Siddha
Tambaram Sanatorium Chennai 47 |
|
|
Primary Sponsor
|
| Name |
National Institute Of Siddha |
| Address |
Room no 7/8 Department of Maruthuvam National Institute of Siddha Tambaram Sanatorium Chennai 47 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 A Surya Dr D Anandhalakshmi Dr A Pavithra |
National Institute of Siddha |
Room no 7/8 Department of Maruthuvam National Institute of Siddha Tambaram Sanatorium Chennai 47
Kancheepuram
TAMIL NADU |
8072897366
22381314
pavithrapaviam8@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: N390||Urinary tract infection, site notspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Vasanthakusumakaram Mathirai |
1 tablet oral route
twice a day for 15 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients with or without the symptoms such as burning micturition, dysuria, supra
pubic pain and scanty urination.
Patients with Uncomplicated UTI .
Patients who are willing to go for urine culture, urine routine and blood investigations
Patients with urine culture significant for bacteria (e.g., Escherichia coli, Klebsiella,
Enterococci, Staphylococcus etc...) |
|
| ExclusionCriteria |
| Details |
Vulnerable groups (Pregnancy and lactation)
K/C/O Genitourinary tuberculosis
K/C/O Diabetes Mellitus
Malignancy
K/C/O Sexually transmitted diseases like HIV, Syphilis
Patient not willing to undergo urine routine and urine culture |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| It is assessed by negative urine culture for bacterial growth |
12 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
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 3 |
|
Date of First Enrollment (India)
|
22/03/2023 |
| 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 PUBLISHED |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
It is an interventional study in which 10 patients with age of 18 to 60 years with or without the symptoms such as burning micturition, dysuria, supra
pubic pain and scanty urination Patients with Uncomplicated UTI Patients who are willing to go for urine culture, urine routine and blood investigations Patients with urine culture significant for bacteria (e.g., Escherichia coli, Klebsiella,
Enterococci, Staphylococcus etc...) will be selected based on inclusion and exclusion criteria. After enrolling the patients in the study 1 tab of VASANTHAKUSUMAKARAM MATHIRAI will be given for 15 days twice a day. Patients will be asked to do urine routine and urine culture before the trial and urine routine urine culture and USG abdomen after the trial. |