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Clinical Trials/CTRI/2025/01/079252
CTRI/2025/01/079252
Not yet recruiting
Phase 2

An Experimental Randomised Prospective Study To Understand The Role Of Individualized Homoeopathic Medicine In Cases Of Uncomplicated Lower Urinary Tract Infection

Rajkot Homoeopathic Medical College Attached with Sainath hospital Parul university1 site in 1 country40 target enrollmentStarted: July 16, 2025Last updated:

Overview

Phase
Phase 2
Status
Not yet recruiting
Sponsor
Rajkot Homoeopathic Medical College Attached with Sainath hospital Parul university
Enrollment
40
Locations
1
Primary Endpoint
There will be some improvement after prescribing Homoeopathic Medicines

Overview

Brief Summary

Uncomplicated urinary tract infections (UTIs) are among the most common bacterial infections encountered in clinical practice. They primarily affect the lower urinary tract, involving the bladder and associated structures. Unlike complicated UTIs, uncomplicated cases occur in otherwise healthy individuals with no structural abnormalities of the urinary tract or significant comorbidities.

Women are usually more susceptible to this infection and has a higher prevalence compared to the men. Poor personal hygiene, pregnancy, menopause, and the close anatomical relationship of the female urethra and the anus are some of the risk factors responsible for high prevalence of UTI. It has a substantial impact on quality of life of females. The incidence of UTI is 0.5 to 0.7 episodes per person per year in females of whom 25% of them have recurrences.Worldwide estimated prevalence is 0.7%. The regional burden of these conditions is estimated to be highest in Asia. (19.7–24.4%).The prevalence of UTI varies from 21.8 to 31.3 % in various parts of India. Out of this, Female 66.78%, Male – 33.22%.Male: Female ratio-1:2.Female of child bearing age are more prone.

Common allopathic treatment antibiotics are recommended for all cases with 3 days treatment norm. trimethoprim or nitrofurantoin are first choice of drug.

High recurrence and antibiotic resistance of bacteria’s causing UTI is also creating burden on economy worldwide.

Most often this infection is usually neglected but it can involve kidney which can be more dangerous. Despite advancements in conventional medical treatments, some patients may experience limitations, adverse effects, or inadequate responses. The study aims to identify whether homeopathic intervention can offer a viable approach to address the limitations of conventional treatments.

Homeopathy is known for its holistic approach to patient care, considering individual symptoms, lifestyle, and emotional well-being. Examining the holistic aspects of homeopathic treatments may contribute to a more comprehensive understanding of managing uncomplicated lower urinary tract infection.

RESEARCH QUESTION:

Will the patient suffering from uncomplicated lower urinary tract infection get better after taking homoeopathic medicines?

**Null hypothesis (H0):-**patient will not get better after taking homoeopathic medicines.

**Alternate hypothesis (H1):-**patient will get better after taking homoeopathic medicines.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
Participant Blinded

Eligibility Criteria

Ages
18.00 Year(s) to 60.00 Year(s) (—)
Sex
Female

Inclusion Criteria

  • Female patients.
  • Age between 18 and 60 year.
  • Patients having clinical symptoms of uncomplicated UTI or pre diagnosed with uncomplicated UTI.

Exclusion Criteria

  • Exhibiting any signs of complicated UTI, pyelonephritis, and/or concomitant vulvovaginitis.
  • Patient below the age of 18 years and the above 60 years of age.
  • Conditions leading to complicated infections like renal disease, urinary tract abnormalities, past urinary surgery, urine catheterization, etc.
  • Patient on immunosuppressive or immune-stimulant therapy within four weeks prior to study entry.
  • Pregnant and lactating mothers.

Outcomes

Primary Outcomes

There will be some improvement after prescribing Homoeopathic Medicines

Time Frame: Outcome will be assessed at 4 weeks

Secondary Outcomes

  • Significant improvement – patient with sense of well-being without any complaints and disappearance of all the symptoms with no relapse or recurrence of symptoms.(Moderate improvement – patient who will have none of the 8 items assessed as worse than mild with maximum score of 8.)

Investigators

Sponsor
Rajkot Homoeopathic Medical College Attached with Sainath hospital Parul university
Sponsor Class
Private medical college
Responsible Party
Principal Investigator
Principal Investigator

Dr Hirva Vyas

Rajkot Homoeopathic Medical College

Study Sites (1)

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