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CTRI Number  CTRI/2026/03/105436 [Registered on: 05/03/2026] Trial Registered Prospectively
Last Modified On: 04/03/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Siddha 
Study Design  Single Arm Study 
Public Title of Study   Clinical Evaluation of a Siddha Medicine for the Treatment of Uncomplicated Urinary Tract Infection” 
Scientific Title of Study   Open-label, Single-arm Clinical Trial to Evaluate Safety, Feasibility and Preliminary Efficacy of proposed Siddha Proprietary UTIC for Management of Uncomplicated Urinary Tract Infection at National Institute of Siddha, Chennai 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrGJ Christian  
Designation  Professor and Head Department of Noi Naadal  
Affiliation  National Institute of Siddha 
Address  Teaching block-2, Department of Noi naadal,National institute of siddha, Tambaram sanatorium, Chennai-47

Chennai
TAMIL NADU
600047
India 
Phone  9962545930  
Fax    
Email  christianvijila@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DrGJ Christian  
Designation  Professor and Head Department of Noi Naadal  
Affiliation  National Institute of Siddha 
Address  Teaching block-2, Department of Noi Naadal, National Institute of siddha, Tambaram sanatorium, Chennai-47

Chennai
TAMIL NADU
600047
India 
Phone  9962545930  
Fax    
Email  christianvijila@gmail.com  
 
Details of Contact Person
Public Query  
Name  DrGJ Christian  
Designation  Professor and Head Department of Noi Naadal  
Affiliation  National Institute of Siddha 
Address  Teaching block-2, Department of Noi Naadal, National Institute of Siddha, Tambaram sanatorium, Chennai-47.

Chennai
TAMIL NADU
600047
India 
Phone  9962545930  
Fax    
Email  christianvijila@gmail.com  
 
Source of Monetary or Material Support  
National Institute of Siddha, Chennai_47 
 
Primary Sponsor  
Name  Ayothidass Pandithar Hospital ,National Institute of Siddha  
Address  National institute of Siddha, Tambaram Sanatorium, Chennai-47 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr G J Christian  Ayothidoss Pandithar Hospital, National Institute of Siddha   OPD and IPD of Ayothidoss Pandithar, Hospital Room No,20/21, ground floor Department of Noi Naadal Tambaram Sanatorium Chennai-47
Chennai
TAMIL NADU 		 9962545930

christianvijila@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE,NATIONAL INSTITUTE OF SIDDHA   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
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  UTIC  Dose 2-3 gm twice a day with warm water 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.Adults aged 18 to 65 years
2.Positive urine culture at baseline showing significant bacterial growth.
 
 
ExclusionCriteria 
Details  1.Individuals with complicated or infection (fever, flank pain, pyelonephritis, or sepsis)
2.Pregnant or breastfeeding women.
3.Those with significant renal or hepatic impairment, urinary tract abnormalities, indwelling catheters, urinary stones, or recent urologic procedures
4.K/C/O Diabetes mellitus
5.Known allergy to any study formulation ingredient, participation in another interventional trial within 30 days, or any condition deemed by the investigator to compromise safety or study compliance.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
The primary outcomes will assess preliminary efficacy. Symptom resolution will be
evaluated using the UTISA scale, which measures the degree of symptoms and associated bother on a 0–3 scale across three domains—urinary regularity, urination problems, and pain related to urination—with a fourth domain assessing hematuria. This will be recorded weekly from baseline to the endpoint. Bacteriologic eradication (negative urine culture) will be assessed on basiline and end point, while the presence of pyuria (pus cells in urine) will be evaluated weekly on Days 7, 14, 21, 28, 35, 42, and 49. 		 UTISA Scale will be assessed on first, second, third, fourth, fifth, sixth and seventh weeks.
Bacterial culture will be assessed on baseline and endpoint.
Pyuria will be evaluated on first, second, third, fourth, fifth,sixth and seventh weeks. 
 
Secondary Outcome  
Outcome  TimePoints 
The secondary outcomes of the study include feasibility and safety parameters. Feasibility
will be assessed through the recruitment rate (target N = 10) monitored throughout the
recruitment period, retention rate evaluated at the end of the study (Week 7), and protocol
adherence measured through dosing and visit compliance during treatment and follow-up.
Safety will be evaluated by monitoring the incidence and severity of adverse events
(AEs/SAEs) continuously through Week 7 and assessing clinically significant changes in
laboratory parameters (CBC, LFT, RFT) at baseline and designated follow-up time points.
 		 Baseline and endpoint 
 
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 2 
Date of First Enrollment (India)   24/03/2026 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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   Urinary tract infection (UTI, GC08.Z) is one of the most common bacterial infections in humansand it disproportionately affects women Worldwide, 150 million patients are diagnosed with UTIs each year. The overall pooled incidence of urinary tract infections was 1.6% They primarily affectthe lower urinary tract, including the bladder and associated structures. Although some cases may resolve spontaneously, many patients seek therapy to relieve symptoms and prevent potential complications. Symptoms include urinary frequency, urgency, dysuria, and suprapubic discomfort.
Currently there are only a few alternatives to antibiotics for treatment of UTI. While antibiotics are the mainstay of therapy, there are growing concerns about collateral effects impacting healthy microbiomes and anti-bacterial resistance patterns. Recent estimates from the CDC indicate that more than 2.8 million antibiotic-resistant infections occur in the U.S. each year, and more than 35,000 people die as a result.
 The proposed research fills a key knowledge gap that will be critical in determining the role of a non-antibiotic substance with the potential to treat UTIs by modulating the quorum sensing, biofilm formation, bacterial adherence to surfaces, degrading the biofilm, to restore health and minimize the reliance on antibiotic therapy while also preventing antibiotic resistance andrecurrence infection . In addition, this study will provide early evidence of the short-term symptom and urinary microbiome changes following administration of Siddha based proprietarily formulated poly – herbal chooranam. The ingredients were also chosen based on the antibacterial and biofilm destruction potential to successfully manage the UTI.
 
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