A Study for the management of infection in urine caused by bacteria E. coli with the help of herbal drugs.

Not yet recruiting

• Conditions: Cystitis, unspecified. Ayurveda Condition: TADIYA-E-MAJRA-E-BAUL,

• Registration Number: CTRI/2021/06/034066
• Lead Sponsor: RAIS UR RAHMAN

Brief Summary

It is a clinical study on the management of Urinary Tract Infection caused by E. coli with a Unani Polyherbal Formulation containing seven drugs namely, Tribulus terrestris, Phyllanthus niruri, Piper cubeba, Cichorium intybus, Apium Graveolens, Glycyrrhiza glabra and Tinospora cordifolia. It would be an Open Single Arm study. Duration of the study will be 1.5 years and duration of the protocol therapy will be 6 weeks. 40 patients will be included in the study. Patient will be given the test drug, prepared in capsule form of Unani Polyherbal Formulation (extract 500mg) thrice a day orally. The safety and efficacy of the test drug will be ensured by monitoring the hemogram with E.S.R. and serological indicators  for kidney and liver functions.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2021-05-06
• Study Start: 2021-06-22

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• DIAGNOSED PATIENTS OF E.
• COLI INDUCED URINARY TRACT INFECTION (BY URINE CULTURE) WILLING TO PARTICIPATE AND SIGN THE INFORMED UNDERSTOOD CONSENT FORM.

Exclusion Criteria

PATIENTS WITH ANY ANATOMICAL ABNORMALITY OF URINARY TRACT, DIABETES MELLITUS, HEPATIC AND RENAL INSUFFICIENCY, PREGNANT AND LACTATING WOMEN, STDs AND HIV.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the safety and efficacy of the proposed Unani Polyherbal Formulation for the management of Urinary Tract Infection caused by E. coli.	Clinical examination and subjective evaluation would be done at baseline, 7 day, 15 day, 30 day and 42 day. Safety evaluation will be performed and recorded at baseline, 7 day and 42 day. | CBC, LFT & KFT would be done.

Secondary Outcome Measures

Name	Time	Method
To develop a safe, efficacious and cost-effective drug from a herbal source for the management of Urinary Tract Infection caused by E. coli	For safety evaluation CBC, LFT & KFT would be done.

Trial Locations

Locations (1)

AYURVEDIC and UNANI TIBBIA COLLEGE and HOSPITAL; 🇮🇳 Central, DELHI, India

AYURVEDIC and UNANI TIBBIA COLLEGE and HOSPITAL

🇮🇳Central, DELHI, India

ALMAS QURESHI

Principal investigator

9953030173

almasqureshi8406@gmail.com