| CTRI Number |
CTRI/2022/07/043722 [Registered on: 05/07/2022] Trial Registered Prospectively |
| Last Modified On: |
23/06/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effectiveness of Homoeopathic treatment of urinary tract infection in female |
|
Scientific Title of Study
|
Effectiveness of complete symptoms using Boenninghausens therapeutic pocket book in the Homoeopathic treatment of urinary tract infection in female- An open observational, prospective clinical study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shweta Gupta |
| Designation |
Post Graduate Trainee |
| Affiliation |
National Institute of Homoeopathy |
| Address |
Department of case taking and repertory, OPD No. 10,
National Institute of Homoeopathy,
Block GE, Sector III, Salt Lake, Kolkata, West Bengal- 700106
North Twentyfour Parganas
WEST BENGAL
700106
India |
| Phone |
8765340909 |
| Fax |
|
| Email |
drshwetagupta2009@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Lokanath Behera |
| Designation |
HOD & Associate Professor |
| Affiliation |
National Institute of Homoeopathy |
| Address |
Department of case taking and repertory, OPD No. 10,
National Institute of Homoeopathy,
Block GE, Sector III, Salt Lake, Kolkata, West Bengal- 700106
North Twentyfour Parganas
WEST BENGAL
700106
India |
| Phone |
9477747610 |
| Fax |
|
| Email |
lokanath.behera@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
Lokanath Behera |
| Designation |
HOD & Associate Professor |
| Affiliation |
National Institute of Homoeopathy |
| Address |
Department of case taking and repertory, OPD No. 10,
National Institute of Homoeopathy,
Block GE, Sector III, Salt Lake, Kolkata, West Bengal- 700106
North Twentyfour Parganas
WEST BENGAL
700106
India |
| Phone |
9477747610 |
| Fax |
|
| Email |
lokanath.behera@yahoo.in |
|
|
Source of Monetary or Material Support
|
| National Institute of Homoeoapthy, Block GE, Sector III, Salt Lake, Kolkata, West Bengal- 700106 |
|
|
Primary Sponsor
|
| Name |
National Institute of Homoeopathy |
| Address |
Block GE, Sector III, Salt Lake, Kolkata, West Bengal- 700106 |
| Type of Sponsor |
Government 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 Shweta Gupta |
National Institute of Homoeopathy |
Department of Case taking and Repertory,OPD No.10, Block GE, Sector III,Salt Lake, Kolkata, West Bengal- 700106
North Twentyfour Parganas
WEST BENGAL |
8765340909
drshwetagupta2009@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL 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 |
| Intervention |
INDIVIDUALISED HOMOEOPATHIC MEDICINE SELECTED ON THE BASIS ON COMPLETE SYMPTOMS BY USING BTPB. |
Intervention will be planned as administering indicated homoeopathic medicine selected on the basis of complete symptoms using BTPB in centesimal or fifty millesimaal potencies. Dose and frequency depends on the condition of the patient. All patients shall be prescribed homoeopathic medicine after detailed case taking in accordance with the direction laid down by Dr. C. S. F. Hahnemann in Organon of medicine. Medicine selection, potency selection, repetition and follow up shall be done on the basis of fundamental guidelines. the follow-up will be done monthly till 3 months from the baseline. |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
1. Patients with clinical findings of urinary tract infection and or pathological reports of urine routine/microscopic.
2. Female patients of age group 18-50 years.
3. Cases supported with urine routine/microscopic, culture report.
4. Patients willing to give written consent to participate in the study.
5. All the patients should know either of Hindi, English, or Bengali. |
|
| ExclusionCriteria |
| Details |
1. Complicated cases of urinary tract infection.
2. Cases suffering from uncontrolled systemic illness or life-threatening illness.
3. Substance abuse and/or dependence.
4. Pregnant women, lactating mothers.
5. Unwilling to take part and not giving consent to join the study.
6. Psychiatric patient.
7. Self-reported immune compromised state. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Visual analogue scale for pain assessment |
Baseline and after 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
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)
|
11/07/2022 |
| 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="6"
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)?
Response - NO
|
|
Brief Summary
|
Urinary tract infection is a common and painful clinical condition. The term UTI encompasses varities of clinical entities, including asymptomatic bacteriurea cystitis, prostatitis and pyelonephritis. UTI can be in any age group but most commonly occur in women in child bearing age group. Homoeopathy plays an important role in treating patient suffering from UTI. So an open observational, prospective clinical study to know the effectiveness of homoeopathic medicine in treatment of UTI will be taken in National Institute of Homoeopathy, Kolkata. Study has a target to achieve a sample of 40 patients. Outcome assesment will be done by using VAS scale for pain at base line and after 3 months. The score obtained by the patients will be compared and result will be analysed as per appropriate statistical methods and interference will be done thereafter. |