NEED FOR THE STUDY:

Urinary tract infections (UTI) are the 3rd most common bacterial infection after respiratory and gastrointestinal infections. Lower urinary tract infections represent one of the most prevalent bacterial infections worldwide, with a significant female predominance. Epidemiological data indicates a staggering prevalence rate of 33.54% with females accounting for 66.78% and males 33.22%. The rampant use of antibiotics had led to a concerning rise in multi-drug resistance among the UTI patients, necessitating alternative therapeutic approaches.

The study on the effectiveness of Homoeopathic medicine Ocimum sanctum in treating Urinary Tract Infections (UTIs) arises from the potential benefits it may offer as an alternative or complementary approach to conventional treatments. With the increasing antibiotic resistance and side effects associated with standard medications, exploring alternative therapies like Ocimum sanctum could provide valuable insights into potential safer and more sustainable treatment options for UTIs. Additionally, the study aims to contribute to the existing body of knowledge in homoeopathy and expand the range of treatment choices for individuals suffering from UTIs.

Ocimum sanctum is a traditional Indian homoeopathic medicine, having properties like Anti-microbial, Anti-oxidants, Anti-inflammatory, Anti-allergic, Anti-diabetic, etc. By experimenting Ocimum Sanctum with its these properties, in cases of lower UTI to avoid uses of antibiotics or when there’s drug resistance in patients. The efficacy of Ocimum sanctum in alleviating UTI symptoms, reducing bacterial load, and combating antibiotic resistance.

By investigating the antimicrobial properties of Ocimum sanctum, with visible results in reports of the patients in urine Routine& Microscopic examination, and reducing the symptoms of UTI, this research offers a potential solution to antibiotic therapy, multi-drug resistance and improvement in patient outcomes.

OBJECTIVE OF THE STUDY:

Aim:

To investigate the effectiveness of Ocimum sanctum in managing Urinary Tract Infections (UTIs) through a comprehensive assessment, incorporating the Measure Yourself Medical Outcome Profile (MYMOP) scale.

Objectives:

To assess the objective clinical outcomes, such as reduction in bacterial load and pus count, following treatment with Ocimum sanctum.

To evaluate the safety profile of Ocimum sanctum in UTI treatment, monitoring for adverse effects or complications.

MATERIAL AND METHODS:  

SOURCES OF DATA:

The patients will be selected from OPD’s, and Peripheral OPD’s and organized Campus of “Sainath Homoeopathic Hospital” of Rajkot Homoeopathic Medical College.

Study duration –

Total duration of the study will be 09 months.

The registration for the first-time screening, case taking and processing will be conducted up to 6-7 months after initiating the research process.

Whereas, on an average 3-4 follow ups will be noted with the duration interval of 5 days (based on individual case).

THE MATERIAL UTILIZED FOR THE STUDY:

Informed consent i.e. – to be signed by every patient.

A specialized designed Case-taking Proforma. (Note – All the records, forms and reports of the patient will be kept confidential.)

MYMOP scale sheet

Various Materia medica for selecting the remedy.

The medicines will be obtained from genuine Homoeopathic pharmacy and dispensed by Dispensary of Sainath Homoeopathic Hospital.

METHOD OF COLLECTION OF DATA:

Type of Study – Qualitative, Experimental, Clinical, Prospective.

Sample Size – 40 cases.

Selection of Cases – Random selection of cases based on the criteria’s of “Sainath Homoeopathic Hospital” attached with Rajkot Homoeopathic Medical College.

Statistical Methods – Data analysis, descriptive statistics and the results will be presented by using frequency table, percentage, diagrams, and graphs. The significance of treatment will be tested using paired ‘t’ test.

Inclusion criteria –

Patients within the age limit of 20-70 years will be included.

Both the sexes – Male and Female will be included.

Patients irrespective of their caste, religion and socio-economic condition.

Exclusion criteria –

Patients below 20 years of age and above 70 years are excluded.

Patients with secondary UTI, complicated UTI, asymptomatic UTI, Upper UTI like pyelonephritis, renal stones are excluded.

Patients with other systemic illness or serious pathological condition.

Withdrawal criteria –

If patient is not benefitting from the treatment, then patients can withdraw.

If the disease is worsening or leads advancing conditions like flank pain, pain at renal angle, generalized symptoms like fever, chill, nausea, vomiting then physician can manage it by another respective homoeopathic medicines and withdraw it from research.

Drop out criteria –

Cases with no follow ups.

Cases without proper follow ups (at least 3 irregular follow - ups).

Intervention –

The selected homoeopathic medicine Ocimum Sanctum will be given to the patients.

The potency will be followed as required by the patients.

Case taking –

Case Taking will be done according to guidelines mentioned by Dr. Hahnemann in aphorisms 83-104 and specially designed format for the study.

Case record –

All the data will be recorded in Standardized case record with the following steps –

1. Case taking

2. Recording an interpretation

3. Analysis of the case

4. Synthesis of the case

5. Repertorization

Source books –

Proper Source books, journals, articles will be used for analyze the case.

Selection of the cases-

Those cases only be selected who comes under the selected medicine Ocimum sanctum.

Selection of potency –

In each case Suitable Potency will be selected according to demand of the case based on Homoeopathic principles, changes in structural and functional level and the degree of correspondence to the remedies.

Dose & repetition –

Dose and Repetition of remedy will be done according to Homoeopathic principles laid down in Organon of Medicine

Route of administration of medicine –

All the medicines will be administrated through oral route.

Follow up and monitoring –

The follow-up of cases will be done up to 3 - 4 follow ups every 5 days interval.

Records –

All the records will be maintained as per standard procedure of institution.

Outcome assessment –

Effectiveness of the treatment was assessed on the basis of –

Clinical improvement – Disappearance or relief of symptoms, improvement in general heath and reduction in pus cells in reports.

For the effective assessment and evaluation, disease intensity scores will also be maintained according to MYMOP scale.

Diagnostic criteria-

Diagnosis will be based upon the clinical presentation of patient (symptomatic), history of the present complaint & laboratory investigations like CBC, Urine Routine& Microscopic, Dipstick urinalysis examinations.

Assessment criteria-

By using MYMOP scale

MYMOP- Measure Yourself Medical Outcome Profile scale

MYMOP is a patient-generated instrument. The first MYMOP form completed for a problem, is generally completed within the consultation. It could be completed before or after this also.

Selection of symptom 1- Ask the patient to say the symptom which is the most important to them, and which they have attended with for help or treatment.

Selection of symptom 2 - Symptom 2 is optional, but to be encouraged. It must be part of the same problem, in the patient’s mind, as symptom 1.

Activity - Activity is optional, but to be encouraged. They choose an activity of daily living which symptoms 1 and 2 prevent or interfere with. Again, this must be what is important to the patient.

Scoring – On questioning ‘how do u feel in yourself? Score how bad it has been, over the last week, on a scale of 0 to 6, with 6 being ‘as bad as it can be’. Then circle a number given by a patient.

0 being: as good as it can be

6 being: as bad as it can be

Follow-up - Follow-up forms can be completed at any interval, and can be sent by post or completed at a subsequent visit. They should have the chosen wording for symptom 1, symptom 2, and activity from MYMOP 1 written in, unchanged, before scoring. Symptom 3 is optional, and only to be added if it is something important to the patient. The patient may write it in and score it.