To compare the effects of Polyherbal Unani Formulation with a standard drug in the Management of Uncomplicated Urinary tract infection.

Phase 2

Not yet recruiting

• Conditions: Acute cystitis,

• Registration Number: CTRI/2025/04/085795
• Lead Sponsor: Ayurvedic and Unani Tibbia college and hospital

Brief Summary

This study is a randomised, parallel group,active control clinical trial to evaluate the Efficacy and safety of the unani drug in the dose of two capsule (each capsule containing 500mg) with Sharbat e Sandal in the management of Uncomplicated Urinary tract infection and to compare it’s efficacy with a standard drug.The microbes responsible for UTI are similar across the world in both advanced and developing nations.These bacteria have developed unique methods of survival and resistance to persist in the urinary system.Unfortunately,UPEC continue to show increased resistance to some of the antibiotics as prescribed in Allopathic system of medicine.

In addition, antibiotic use may harm patients suffering from asymptomatic bacteriuria.It was concluded to be beneficial not to treat younger women suffering from asymptomatic bacteriuria with antibiotics due to a possible protective effect of colonizing bacteria.Solely symptomatic treatment of acute uUTI also seems to be an option.

Therefore,in place of antibiotics prescribed in Allopathic system of medicine and it’s arising resistance towards asymptomatic UTIs,The safety and efficacy of suitable herbal drug Kabab chini(Cubeba officinalis) have not been evaluated on scientific parameters.

Hence,there is a need to develop a safe, efficacious and economical drug on modern scientific parameters from the herbal treasury of Unani medicine for the treatment of uUTI.

The purpose of this study is to provide a safe and effective drug for managing uUTI and to compare it’s efficacy with a standard drug.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2025-04-22
• Study Start: 2025-07-05

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Female
• Target Recruitment: 50

Inclusion Criteria

• 1.Patient willing to participate in the study and sign the informed consent form.
• 2.Female patients of the reproductive age group between 20-45 years.
• 3.Presenting with acute following symptoms(Burning micturition,dysuria, frequency and urgency) 4.Diagnose cases of urinalysis showing pus cells (7-10 white blood cells per high-powered field).

Exclusion Criteria

• 1.Below 20 and 45 years 2.Any signs evoking complicated UTI, pyelonephritis (fever more or equal 38 degree Celsius, back pain,chills and shivers.
• 3.Concomitant vulvovaginitis.
• 4.Conditions leading to complicated infections (Renal diseases, urinary tract abnormalities,past urinary surgery, urine catheterization etc) 5.Pregnancy and lactating mother 6.Cardiovascular diseases and any systematic illness.
• 7.H/o Sexually transmitted diseases 8.Immune compromised pateints.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.To assess the safety and efficacy of the proposed Unani Formulation on scientific parameters.	Improvement in signs and symptoms of uUTI patient at 15 days from base line
2.To compare the results of Unani Formulation with the standard control in the treatment of uUTI in respect of safety and efficacy.	Improvement in signs and symptoms of uUTI patient at 15 days from base line

Secondary Outcome Measures

Name	Time	Method
To evaluate the effect of Unani polyherbal formulation on quality of the patient	Change in urinalysis showing pus cells at 15 days from base line

Trial Locations

Locations (1)

Ayurvedic and Unani Tibbia college and hospital; 🇮🇳 Central, DELHI, India

Ayurvedic and Unani Tibbia college and hospital

🇮🇳Central, DELHI, India

Dr HUZAIFA FATHIMA P

Principal investigator

8682989724

huzaifafathima021@gmail.com