| CTRI Number |
CTRI/2025/01/079316 [Registered on: 23/01/2025] Trial Registered Prospectively |
| Last Modified On: |
23/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Homoeopathic Medicine to treat Urinary Infection in female |
|
Scientific Title of Study
|
Scope of Homoeopathic medicine in Urinary Infection in female |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Toral Harshadbhai Patel |
| Designation |
M D Scholar Part 2 |
| Affiliation |
C D Pachchigar college of Homoeopathic Medicine and Hospital |
| Address |
C D Pachchigar college of Homoeopathic Medicine and Hospital
Near anand Mangal Society Udhana Magdalla Road Surat
Department of Homoeopathic Materia Medica Division of 2nd floor C D Pachcigar colege of Homoeopathic medicine and Hospital Surat Gujarat
Surat
GUJARAT
395001
India |
| Phone |
9712683093 |
| Fax |
|
| Email |
toralpatel3399@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR KHATRI MUKESH PARMANAND |
| Designation |
Associate Professor of Department of Homoeopathic Materia Medica |
| Affiliation |
C D Pachchigar college of Homoeopathic Medicine and Hospital |
| Address |
C D Pachchigar college of Homoeopathic Medicine and Hospital
Near anand Mangal Society Udhana Magdalla Road Surat
Department of Homoeopathic Materia Medica Division of 2nd floor C D Pachcigar colege of Homoeopathic medicine and Hospital Surat Gujarat
Surat
GUJARAT
395001
India |
| Phone |
9429012500 |
| Fax |
|
| Email |
mukeshkhatri5@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR KHATRI MUKESH PARMANAND |
| Designation |
Associate Professor of Department of Homoeopathic Materia Medica |
| Affiliation |
C D Pachchigar college of Homoeopathic Medicine and Hospital |
| Address |
C D Pachchigar college of Homoeopathic Medicine and Hospital
Near anand Mangal Society Udhana Magdalla Road Surat
Department of Homoeopathic Materia Medica Division of 2nd floor C D Pachcigar colege of Homoeopathic medicine and Hospital Surat Gujarat
Surat
GUJARAT
395001
India |
| Phone |
9429012500 |
| Fax |
|
| Email |
mukeshkhatri5@gmail.com |
|
|
Source of Monetary or Material Support
|
| 1.C D Pachchigar college of Homoeopathic Medicine and Hospital
Near anand Mangal Society Udhana Magdalla Road Surat 2. Peripheral centre and regular camp visit of C D Pachchigar college of Homoeopathic Medicine and Hospital |
|
|
Primary Sponsor
|
| Name |
C D Pachchigar college of Homoeopathic Medicine and Hospital |
| Address |
C D Pachchigar college of Homoeopathic Medicine and Hospital, near aanand mangal society, Udhana magdalla road, Bhatar, Surat-395001
Near anand Mangal Society Udhana Magdalla Road Surat |
| 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 Toral Harshadbhai Patel |
C D Pachchigar College Of Homoeopathic Medicine And Hospital |
Department Of Homoeopathic Materia Medica, Division Of 2nd FloorCD Pachchigar college of Homoeopathic Medicine and Hospital,near aanad mangal Society, Udhana magdalla road, Bhatar, Surat-395001
Surat
GUJARAT |
9712683093
toralpatel3399@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institution Ethical Committee of C.D.Pachchigar college of Homoeopathic medicine and Hospital of C D Pachchigar college of Homoeopathic Medicine and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N30||Cystitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Homoeopathic Medicine |
Homoeopathic Medicine Dose as per requiredment of case through sublingual mode of administration |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
1. Patient of age group 10 years to 60 years female
2. Cases having co-morbid condition Diabetes, Hypertension, Urolithiasis, Fibroid of Uterus, Polycystic ovarian disease, Hypothyroidism, Hyerthyroidism
3. Cases who are carrying Uterine Pregnancy
4. Cases who had already inserted Intra Uterine Contraceptive Debice |
|
| ExclusionCriteria |
| Details |
1. Patient of age less than 10 years and above 60 years
2. Cases with Co-morbid condition like Cervical cancer, Chronic kidney failure, Bladder cancer, Tubercular Cystitis
3. Cases who are simultaneously taking modern medicine for Cystitis and Urethritis |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| TO assess indiacated Homoeopathic medicine, incidence and prevelence rate, diet and regimen and comorbid condidtion in cases of cystitis and urethritis in females |
As per condition of patient |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the incidence & prevalemce rate, to study homoeopathic therapeautics, to asses & study diet & regimen of Cystitis & Urethritis, to asses the comorbid condition with Cystitis & Urethritis |
As per condition of patient |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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
|
N/A |
|
Date of First Enrollment (India)
|
03/02/2025 |
| 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 Applicable |
| 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
|
Urinary Tract Infection is defined as a condition in which bacteria enter, persist and multiply within the Urinary tract. Lower Urinary Tract Infection includes Urinary Bladder infection (Cystitis) and Urethra infection (Urethritis) Which is Clinically menifested as Frequent Urination, Offensive urine, Incontinence, Dysuria, Suprapubic pain, Urgency, Haematuria, Urethral discharge. Objective of study : To assess the incidence and prevalence rate , To study Homoeopathic therapeautics, To assess and study diet and regimen of Cystitis and Urethritis, To survey the rate of different co-morbid condition with Cystitis and Urethritis in females. Methodology of Prospective study with Purposive sampling method. |