Clinical study on Ayurin Capsule in urine infection

An evaluation of efficacy and safety of Ayurin Capsule in subjects suffering from uncomplicated urinary tract infection â?? An open labeled, multi-center, non-comparative, interventional, prospective, clinical study. - NIL

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/08/035483

Enrollment

Registered

2021-08-06

Start date

Unknown

Completion date

Unknown

Last updated

2023-07-25

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

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1. Clinical presentation of uncomplicated urinary tract infection, the disease duration should not be more than 3 days. 2. Urine routine and microscopic test suggestive of urinary tract infection 3. Subjects who did not receive antibiotic treatment within last 3 days prior to screening 4. Subjects ready to provide written informed consent before initiation of any study procedures and be available for all study visits

Exclusion criteria

Exclusion criteria: 1. Subjects with history of urinary calculi six months prior to screening 2. Subjects with history of severe urinary obstruction pathology, urinary tuberculosis, renal papillary necrosis, perinephric abscess or neurogenic bladder 3. Subjects presenting vaginitis symptoms, genital ulcers or gonorrhea 4. Subjects with cardiopulmonary disease, liver and kidney disease, advanced tumor, blood, central nervous system or other serious or progressive disease 5. Subjects who need antibiotics for Urinary tract infection 6. Subjects with known allergy to any ingredient of the test drug 7. Those who have participated in other clinical trials within one month before being selected 8. Known case of venereal disease 9. Any other condition due to which patients are deemed to be unsuitable by the investigator for reason not specifically started in the exclusion criteria

Design outcomes

Primary

Measure	Time frame
1. Changes in clinical symptoms of uncomplicated UTI (dysuria, frequency, urgency, suprapubic pain) over a period of 14 days. 2. Changes in urine routine and microscopic test with respect to urinary tract infection Timepoint: Day -1, Day 0, Day 3, Day 7, Day 10 and Day 14	—

Secondary

Measure	Time frame
1. Change in fever (if any) 2. Assessment of number of days required for complete resolution of symptoms 3. Change in Activity Impairment Assessment (AIA) 4. Change in proportion of cases with complete absence of symptoms of UTI 5. Assessment of rescue medications (use of antibiotics and urinary alkalizer) 6. Global assessment for overall improvement by the subject and investigator 7. Tolerability of study drug by assessing ADRs on study completion Timepoint: Day -1, Day 0, Day 3, Day 7, Day 10 and Day 14	—

Measure

Time frame

1. Change in fever (if any) 2. Assessment of number of days required for complete resolution of symptoms 3. Change in Activity Impairment Assessment (AIA) 4. Change in proportion of cases with complete absence of symptoms of UTI 5. Assessment of rescue medications (use of antibiotics and urinary alkalizer) 6. Global assessment for overall improvement by the subject and investigator 7. Tolerability of study drug by assessing ADRs on study completion Timepoint: Day -1, Day 0, Day 3, Day 7, Day 10 and Day 14

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Countries

India

Contacts

Public ContactDr Sanjay Tamoli

Target Institute of Medical Education and Research

targetinstitute@yahoo.com9322522252

Outcome results