| CTRI Number |
CTRI/2026/02/104197 [Registered on: 18/02/2026] Trial Registered Prospectively |
| Last Modified On: |
17/02/2026 |
| 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 on Aali Vidhai Manapagu in the management of Azhal Neer Churukku (Urinary Tract Infection) |
|
Scientific Title of Study
|
A prospective open labelled, single arm, non- randomized, single centric, phase II clinical trial to determine the effectiveness of Aali Vidhai Manapagu in the management of Azhal Neer Churukku (Urinary Tract Infection) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr T Sathishkumar |
| Designation |
Pg scholar |
| Affiliation |
Government Siddha Medical College and Hospital |
| Address |
OP Number 10 PG Department of Pothu Maruthuvam
Government Siddha Medical College and Hospital
Palayamkottai.
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
7502728862 |
| Fax |
|
| Email |
sathishbsms097@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr G Subash Chandran MD S PhD |
| Designation |
Professor |
| Affiliation |
Government Siddha Medical College and Hospital |
| Address |
PG 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 S Justus Antony |
| Designation |
Head of the Department |
| Affiliation |
Government Siddha Medical College and Hospital |
| Address |
PG Department of Pothu Maruthuvam
Government Siddha Medical College and Hospital
Palayamkottai.
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9443090849 |
| Fax |
|
| Email |
justusantony71@gmail.com |
|
|
Source of Monetary or Material Support
|
| OPD and IPD Facilities and Central Library of Government Siddha Medical College and Hospital, Palayamkottai |
|
|
Primary Sponsor
|
| Name |
Government Siddha Medical College and Hospital |
| Address |
Government siddha medical college and Hospital
Thiruvanandhapuram Main road
Palayamkottai
tirunelveli 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 |
| Dr T Sathishkumar |
Government Siddha Medical College and Hospital |
OP no:10 PG Department of Pothu Maruthuvam
Government siddha medical College and Hospital
Palayamkottai
Tirunelveli 627002
Tirunelveli
TAMIL NADU |
7502728862
sathishbsms097@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE(2024-2027) GOVERNMENT SIDDHA MEDICAL COLLEGE AND HOSPITAL, PALAYAMKOTTAI,TIRUNELVELI 627002 |
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 |
AALI VIDHAI MANAPAGU |
Dosage-20 ml with Lukewarm Water-After food Twice a Day
Duration -10 days |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients having symptoms with burning micturition/ dysuria
2.Fever with chills (less than 104 degree F),
3.Frequency of micturition, hematuria, pain over the suprapubic region, and low back pain (Assessed by UTISA questionnaire)
4.Renal calculus( less then 10 mm )
5.Patients who are willing to go for urine culture & undergo routine blood investigation
6.Patient willing to sign the informed consent indicating that they understand the purpose and procedures required for the study and are willing to participate in the study. |
|
| ExclusionCriteria |
| Details |
1.Pregnant
2.Lactating mother
3.Recent malignancy or radiation therapy
4.Patients considered unreliable by the investigator (e.g., drug addiction, alcohol abuse)
5.H/O Sexually transmitted disease
6.Hydronephrosis
7.Medical renal disease
8.Hyper pyrexia
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The outcome aims to reduce the symptoms of Azhal Neer Churukku (Urinary Tract Infection) and to determine the effectiveness of Aali Vidhai Manapagu. |
10 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To collect various Siddha literatures and modern journals for literature review on AZHAL NEER CHURUKKU ( URINARY TRACT INFECTION )
2.To study other cofactors related to disease like age, sex, dietary habits, family history, and socioeconomic status.
3.To perform physicochemical, phytochemical, bio chemical analysis of AALI VIDHAI MANAPAGU
4.To evaluate pharmacological activities of AALI VIDHAI MANAPAGU
5.To study about the prevalence of AZHAL NEER CHURUKU in relation with diet and lifestyle.
6.To evaluate Siddha parameters (including Envagai thervu) in AZHAL NEER CHURUKKU during trial period.
7.To evaluate modern parametric changes in AZHAL NEER CHURUKKU.
|
6 Months |
|
|
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)
|
25/03/2026 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a PROSPECTIVE OPEN LABELLED, SINGLE ARM, NON- RANDOMIZED, SINGLE CENTRIC, PHASE II CLINICAL TRIAL TO DETERMINE THE EFFECTIVENESS OF AALI VIDHAI MANAPAGU THE MANAGEMENT OF AZHAL NEER CHURUKKU ( URINARY TRACT INFECTION) . The trial drug AALI VIDHAI MANAPAGU is freshly prepared and will be administrated at a dosage of 20 ml (twice a day orally ) with lukewarm water as adjuvant for 10 days for 40 known AZHAL NEER CHURUKKU ( URINARY TRACT INFECTION) patients (20 OP and 20 IP ) . The primary outcome will be determine the clinical effectiveness of AALI VIDHAI MANAPAGU (INTERNAL) in the management of AZHAL NEER CHURUKKU ( URINARY TRACT INFECTION ). The secondary outcome will be To collect various Siddha literatures and modern journals for literature review on AZHAL NEER CHURUKKU ( URINARY TRACT INFECTION ) ,To study other cofactors related to disease like age, sex, dietary habits, family history, and socioeconomic status, To perform physicochemical, phytochemical, bio chemical analysis of AALI VIDHAI MANAPAGU To evaluate pharmacological activities of AALI VIDHAI MANAPAGU, To study about the prevalence of AZHAL NEER CHURUKU in relation with diet and lifestyle ,To evaluate Siddha parameters (including Envagai thervu) in AZHAL NEER CHURUKKU during trial period, To evaluate modern parametric changes in AZHAL NEER CHURUKKU.
|