| CTRI Number |
CTRI/2025/01/079252 [Registered on: 22/01/2025] Trial Registered Prospectively |
| Last Modified On: |
17/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Utility of homoeopathic medicines in cases of uncomplicated lower urinary tract infection |
|
Scientific Title of Study
|
An Experimental Randomised Prospective Study To Understand The Role Of Individualized Homoeopathic Medicine In Cases Of Uncomplicated Lower Urinary Tract Infection |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Hirva Vyas |
| Designation |
PG Scholar |
| Affiliation |
Rajkot Homoeopathic Medical College |
| Address |
Department of Organon of Medicine and Homoeopathic Philosophy, Rajkot Homoeopathic Medical
College, behind jainath complex, makkam chowk, Gondal road,
Rajkot
Rajkot
GUJARAT
360002
India |
| Phone |
8140359291 |
| Fax |
|
| Email |
hirvyas9314@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Priyanka Shroff |
| Designation |
Head of department and Professor |
| Affiliation |
Rajkot Homoeopathic Medical College |
| Address |
Department of Organon of Medicine and Homoeopathic Philosophy, Rajkot Homoeopathic Medical
College, behind jainath complex, makkam chowk, Gondal road,
Rajkot
Rajkot
GUJARAT
3600002
India |
| Phone |
9898930311 |
| Fax |
|
| Email |
drshroff3@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Hirva Vyas |
| Designation |
PG Scholar |
| Affiliation |
Rajkot Homoeopathic Medical College |
| Address |
Department of Organon of Medicine and Homoeopathic Philosophy, Rajkot Homoeopathic Medical
College, behind jainath complex, makkam chowk, Gondal road,
Rajkot
Rajkot
GUJARAT
360002
India |
| Phone |
8140359291 |
| Fax |
|
| Email |
hirvyas9314@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rajkot Homoeopathic Medical College attached with Sainath Hospital , Parul University,behind jainath complex, makkam chowk,gondal road,rajkot.Gujarat,India, 360002. |
|
|
Primary Sponsor
|
| Name |
Rajkot Homoeopathic Medical College Attached with Sainath hospital Parul university |
| Address |
Rajkot Homoeopathic Medical College, behind Jaynath complex, Makkam chowk, Gondal road, Rajkot Gujarat,India, 360002. |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Hirva Vyas |
Rajkot Homoeopathic Medical College attached with Sainath Hospital, Parul university |
Behind Jaynath complex, Makkam chowk, Gondal road, Rajkot, Gujarat, India 360002
Rajkot
GUJARAT |
8140359291
hirvyas9314@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee for Human Research - Rajkot Homoeopathic medical College(RHMC), Parul university |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N390||Urinary tract infection, site notspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualised Homoeopathic Medicine |
Individualized homoeopathic
medicine. Mode of Administration: Oral (sublingual) Selection of potency, dose and repetition : individualised medicine will be prescribed in 30, 200, 1 M potency. Selection of dosage, potency and repetition will be according to susceptibility of patient and principles of organon of medicine. Total Duration of study 9 months. |
| Comparator Agent |
not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
Female patients.
Age between 18 and 60 year.
Patients having clinical symptoms of uncomplicated UTI or pre diagnosed with uncomplicated UTI.
|
|
| ExclusionCriteria |
| Details |
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.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| There will be some improvement after prescribing Homoeopathic Medicines |
Outcome will be assessed at 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
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.
Mild improvement – sum score is less than 12 and does not fulfil the criteria for moderate improvement.
No improvement / status quo – there is no considerable change in any symptoms. |
There will be some improvement after prescribing homoeopathic medicines after 9 months |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
16/07/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="9"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
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. |
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