| CTRI Number |
CTRI/2021/11/037773 [Registered on: 02/11/2021] Trial Registered Prospectively |
| Last Modified On: |
31/10/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Siddha
Screening |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical trial to study the effect of the drug Kandhaga Rasayanam in patients having Azhal Neerchurukku (Urinary Tract Infection) |
|
Scientific Title of Study
|
Phase II Non-Randomized Open Clinical Evaluation of siddha medicine Kandhaga Rasayanam for the management of Azhal Neer churukku (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 Sangeetha NR |
| Designation |
PG Scholar |
| Affiliation |
Government Siddha Medical College |
| Address |
Post Graduate Department of General Medicine, Govt Siddha Medical college, Arumbakkam, Chennai-106
Chennai
TAMIL NADU
600106
India |
| Phone |
6385485149 |
| Fax |
|
| Email |
sangeetharajendiran13@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Menaka R |
| Designation |
Lecturer |
| Affiliation |
Government Siddha Medical College |
| Address |
Post Graduate Department of General Medicine, Govt Siddha Medical college, Arumbakkam, Chennai-106
Chennai
TAMIL NADU
600106
India |
| Phone |
9444669661 |
| Fax |
|
| Email |
rangasamymenaka75@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Menaka R |
| Designation |
Lecturer |
| Affiliation |
Government Siddha Medical College |
| Address |
Post Graduate Department of General Medicine, Govt Siddha Medical college, Arumbakkam, Chennai-106
Chennai
TAMIL NADU
600106
India |
| Phone |
9444669661 |
| Fax |
|
| Email |
rangasamymenaka75@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Siddha Medical College, Arumbakkam, Chennai 106 |
|
|
Primary Sponsor
|
| Name |
Government Siddha Medical College |
| Address |
Government Siddha Medical College, Arumbakkam, Chennai-106 |
| 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 Sangeetha NR |
Arignar Anna Government hospital of Indian Medicine |
Room no2, Post
Graduate Department
of General Medicine,
Arignar Anna
Government hospital of
Indian Medicine
Arumbakkam
Chennai-106
Chennai
TAMIL NADU |
6385485149
sangeetharajendiran13@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 |
| Intervention |
Kandhaga Rasayanam |
1to2 gm, twice a day for 15 days |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Subjrcts within 20-60 years, having symptoms such as, Frequency of Urination, Burning micturition, Dysuria, Lower abdominal pain, Low bach ache, Hematuria, patients with significant for bacteria in urine culture, patients having moderate to severe symptoms according to UTI symptom assessment scale |
|
| ExclusionCriteria |
| Details |
Pregnant women, History of Diabetes mellitus,
History of sexually transmitted disease, History of Malignancy will be excluded |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| It is mainly assessed by reduction in clinical signs and symptoms by UTI symptom assessment score and also assessed by urine culture when bacterial/fungal infection becomes negative after treatment |
15 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| By comparing the clinical signs and symptoms and the urine culture before and after the treatment |
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)
|
15/11/2021 |
| 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 phase II Non- Randomized open clinical trial to study the safety and efficacy of siddha medicine Kandhaga Rasayanam for Azhal Neerchurukku (Urinary tract Infection). The trial drug is given 1 to 2 gm twice a day for 15 days. Clinical trial is conducted after conducting the preclinical toxicity study. The Trial drug Kandhaga Rasayanam is mentioned in the book Siddha vaidhya thirattu. 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. |