Clinical Evaluation of a Siddha Medicine for the Treatment of Uncomplicated Urinary Tract Infection

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 - nil

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/03/105436

Enrollment

Registered

2026-03-05

Start date

Unknown

Completion date

Unknown

Last updated

2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: N390- Urinary tract infection, site notspecified

Interventions

Intervention1: UTIC: Dose 2-3 gm twice a day with warm water Control Intervention1: NIL: NIL

Eligibility

Inclusion criteria

Inclusion criteria: 1.Adults aged 18 to 65 years 2.Positive urine culture at baseline showing significant bacterial growth.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
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.Timepoint: 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.	—

Measure

Time frame

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.Timepoint: 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.

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Secondary

Measure	Time frame
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. Timepoint: Baseline and endpoint	—

Measure

Time frame

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. Timepoint: Baseline and endpoint

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Countries

India

Contacts

Public ContactDrGJ Christian

National Institute of Siddha

christianvijila@gmail.com9962545930

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Apr 4, 2026