| CTRI Number |
CTRI/2020/06/026117 [Registered on: 24/06/2020] Trial Registered Prospectively |
| Last Modified On: |
23/06/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Homoeopathy in acute uncomplicated Urinary Tract Infection |
|
Scientific Title of Study
|
The usefulness of individualized Homoeopathy versus standard allopathic treatment in acute uncomplicated Urinary Tract Infection (UTI): A randomised comparative trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Deepti Singh |
| Designation |
Research Officer(H)/Scientist-1 |
| Affiliation |
Central Council for Research in Homoeopathy |
| Address |
61-65, Institutional Area, Janak Puri D block
New Delhi
DELHI
110058
India |
| Phone |
09818785593 |
| Fax |
|
| Email |
dr.deepti.2821@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Praveen Oberai |
| Designation |
Scientist-4 |
| Affiliation |
Central Council for Research in Homoeopathy |
| Address |
Room no 408, 61-65, Institutional Area, Janak Puri D block
New Delhi
DELHI
110058
India |
| Phone |
9811952274 |
| Fax |
|
| Email |
oberai.praveen@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anil Khurana |
| Designation |
Director General Incharge |
| Affiliation |
Central Council for Research in Homoeopathy |
| Address |
Room no 408, third floor, 61-65, Institutional Area, Janak Puri D block
New Delhi
DELHI
110058
India |
| Phone |
9911127619 |
| Fax |
|
| Email |
anil23101961@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Central Council for Research in Homoeopathy |
| Address |
61-65, Institutional Area,
Opp D Block Janak Puri
|
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Chittaranjan Kundu |
Dr Anjali Chatterjee Regional Research Institute for Homoeopathy |
50 Rajendra Chatterjee Road
Kolkata 700046
Kolkata
WEST BENGAL |
9474543940
dr.kundu1984@gmail.com |
| Dr Bharti Wadhwa |
Dr DP Rastogi Central Research Institute for Homoeopathy |
A-1/1 Sector-24
Noida
Gautam Buddha Nagar
UTTAR PRADESH |
9818262049
bhartiwadhwa@gmail.com |
| Dr Deepthi Gilla |
National Homoeopathic Research Institute in Mental Health |
Sachivothamapuram
Kottayam 686532
Kottayam
KERALA |
8111990221
drdeepthigilla@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
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 |
| Comparator Agent |
Allopathy |
Standard Allopathic treatment
Allopathic medicine shall be given to the patients in the allopathic group as prescribed by the qualified allopathic doctor engaged in the study, as per individual case dose and frequency shall be advised by the allopathic physician.
|
| Intervention |
Homoeopathy |
Individualized Homoeopathy medicine based on the presentation of each case.
Each dose of indicated Homoeopathic medicine shall consist of four globules (size no. 30)in 30C or 200c or 1M potency as per the indications of patints. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of both sexes aged 18-60 years presenting with clinical signs and symptoms of uncomplicated UTI. Any two or more from the following:
(a) Dysuria &/or urinary frequency, or urinary urgency, &/or abdominal/suprapubic pain.
2. Patients who had not taken antimicrobials within the last 2 weeks.
3. Patients willing to give informed consent |
|
| ExclusionCriteria |
| Details |
1. Pregnant, breastfeeding women.
2. Patients presenting with signs and symptoms of complicated UTI (those arising in a setting of catheterization, instrumentation, urologic anatomic or functional abnormalities, stones, obstruction, immunosuppression, cancer, renal or hepatic disease.
3.Known cases of uncontrolled diabetes, hypertension.
4.Patients unable or unwilling to give informed consent. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess and compare clinical outcome of treatment with homoeopathic medicine and allopathic medicine in uncomplicated UTI [symptom severity and duration using UTI Symptoms Assessment questionnaire (UTISA)] |
Day 0, 3, 7, 10. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To compare the changes in quality of life in response to both treatment groups.
2. To compare the changes in urine culture after homoeopathic Vs. allopathic treatment (micro biological outcome).
3. To assess any recurrence of sign/symptoms of UTI during 6 months follow-up. |
Day 0, 3, 7, 10.
Monthly recall till 06 months. |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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 3 |
|
Date of First Enrollment (India)
|
30/07/2020 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Urinary tract infection (UTI) is among the most prevailing infectious diseases with a substantial financial burden on society. It is estimated that 150 million UTIs occur yearly world-wide, accounting for $6 billion in health care expenditure. In general, the treatment consists of hydration, relief of urinary tract obstruction (if the cause) and judicious use of antibiotics. The present state of microbial resistance development is alarming. Prudent use of available antibiotics is the option to delay the development of resistance and there is necessity of exploring other treatment options. Various studies support that homoeopathic treatment is equivalent in effectiveness to antibiotics for certain human infectious diseases. Homoeopathy can be promoted as the first line of treatment for common day to day infectious diseases. The emerging anti-microbial resistance (AMR) can be tackled with Homoeopathy as adjuvant therapy for infectious diseases. Homeopathy in addition to conventional prophylactic measures seems to be an effective, promising method for the prevention of recurrent UTI in patients with SCI. There is very scarce literature to show usefulness of Homoeopathy in UTI. Clinical study to observe the usefulness of Homoeopathy in symptomatic relief, prevention of secondary complications (e.g. pyelonephritis) and improvement of quality of life is warranted. |