Study to Understand the Effect of Ayurvedic Management of Urinary Tract Infection

Phase 3

Completed

• Conditions: Urinary tract infection, site notspecified. Ayurveda Condition: MUTRAKRUCCRAM,

• Registration Number: CTRI/2018/02/012156
• Lead Sponsor: FRLHT Trust

Brief Summary

**Introduction:**

Urinary tract infections (UTIs) are one of the most common bacterial infections and a severe public health problem affecting 150 million people each year worldwide. Antibiotics are drug of choice to treat bacterial UTIs. Due to increasing incidence of antibiotic resistance,  preventative approaches such as immune-modulation along with antimicrobial activity need to be encouraged more vigorously. Ayurvedic medicines/ herbs indicated in the texts have shown their efficacy in preventive care/ immune-modulation/ antimicrobial activity through the clinical studies, hence promising alternative of treating or reducing such infections. This exploration encourages us to evident Ayurvedic management for UTI through a defined clinical study. Ayurvedic drugs that would be used in the current study are being used in routine clinical practice and no known adverse reaction has been reported.

**Aim:** **To determine the efficacy of Classical Ayurvedic Management of uncomplicated UTI in adult females**

**Single arm, Open labeled, non – randomized, pre-post clinical study**

Total duration of clinical study is 18 months

Time point of data collection

1.      Visit 1 - Baseline visit

2.      Visit 2(15th day),3(at 30th day) and4(60th day) – Treatment and follow-up

3.      Visit 5(120th day- it could be a telephonic interview-site visit is not mandatory) – Follow-up

**Primary end point of Study**

1.      Reduction in number and severity of symptoms.

2.      Reduction in number of pus cells- Pyuria- in urine

3.      Reduction of Bacterial colony count.

Inclusion criteria

a.    Female patients with clinical symptoms of UTI (frequency, urgency, burning micturition/dysuria, foul smelling urine, lower abdomen pain) aged between 18-59 years old

b.    Positive for pus cells(>6) along with Culture yielding >1000 CFU

c.    Patients who had not taken antimicrobials within the last 4 weeks

Exclusion criteria

a.         Upper UTI

b.        Complicated cases of UTI such as Anatomical and physiological anomalies in urinary tract, any underline disease such as Calculi, impaired kidney function, Pyelonephritis, Diabetes mellitus etc.

c.         Pregnant or nursing mother

 Efficacy/ effect Parameters

Clinical symptoms and laboratory findings will be indicator of efficacy. Assessment will be made on following criteria during follow-up:

1.         Changes in clinical symptoms

2.         Bacterial colony count on urine culture

3.         Changes in number of pus cells, ESR and CRP

 **Benefit of study:**

This study will provide documentary proof of the efficacy of Ayurvedic management of UTI. Positive study results could make a big contribution for the society by reducing-

1.         Unnecessary use of antibiotic that would lead to antibiotic resistance

2.         Adverse effects due to repeated antibiotic usage

3.         Burden of infection

4.         Healthcare expenses

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-03
• Study Completion: 2019-01-11
• Last Update Posted: 2021-12-07

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

• a.Female patients with clinical symptoms of UTI (frequency, urgency, burning micturition/dysuria, foul smelling urine, lower abdomen pain) aged between 18-59 years old.
• b.Positive for pus cells(>6) along with Culture yielding >1000 CFU.
• c.Patients who had not taken antimicrobials within the last 4 weeks.

Exclusion Criteria

• a.Upper UTI b.Complicated cases of UTI such as Anatomical and physiological anomalies in urinary tract, any underline disease such as Calculi, impaired kidney function, Pyelonephritis, Diabetes mellitus etc.
• c.Pregnant or nursing mother.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary	60 days
1.Reduction in number and severity of symptoms.	60 days
2.Reduction in number of pus cells- Pyuria- in urine	60 days
3.Reduction of Bacterial colony count.	60 days

Secondary Outcome Measures

Name	Time	Method
Reduction in inflammatory markers - CRP and ESR	60 days

Trial Locations

Locations (1)

Institute of Ayurveda and Integrative Medicine; 🇮🇳 Bangalore, KARNATAKA, India

Institute of Ayurveda and Integrative Medicine

🇮🇳Bangalore, KARNATAKA, India

Dr Neelambika GB

Principal investigator

8095459122

neelambika@iaimhealthcare.org