| CTRI Number |
CTRI/2025/08/093330 [Registered on: 20/08/2025] Trial Registered Prospectively |
| Last Modified On: |
20/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to find out how much useful Homoeopathic Medicines are in treating Cystitis |
|
Scientific Title of Study
|
Exploring the Role of Homoeopathic Medicine in Management of Urinary Tract Infection-Cystitis: A Clinical Study |
| 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. Shivani Kishnakant Rathod |
| Designation |
PG Scholar MD Part 2 |
| Affiliation |
S. S. Agrawal Homoeopathic Medical College and General Hospital, Navsari |
| Address |
PG division, 5th floor,Department of Practice of Medicine, Near Devina Park Society Gandevi Road ,Navsari Gujarat India
Navsari
GUJARAT
396445
India |
| Phone |
09913787052 |
| Fax |
|
| Email |
shiva15rathod@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Nirali Tandel |
| Designation |
Assistant professor |
| Affiliation |
S. S. Agrawal Homoeopathic Medical College and General Hospital, Navsari |
| Address |
PG division, 5th floor, Department of Practice of Medicine, Near Devina Park Society Gandevi Road ,Navsari Gujarat India
Navsari
GUJARAT
396445
India |
| Phone |
9309193892 |
| Fax |
|
| Email |
niralitandel30@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Nirali Tandel |
| Designation |
Assistant Professor |
| Affiliation |
S. S. Agrawal Homoeopathic Medical College and General Hospital, Navsari |
| Address |
PG division, 5th floor, Department of Practice of Medicine, Near Devina Park Society Gandevi Road ,Navsari Gujarat India
Navsari
GUJARAT
396445
India |
| Phone |
9309193892 |
| Fax |
|
| Email |
niralitandel30@gmail.com |
|
|
Source of Monetary or Material Support
|
| S. S. Agrawal Homoeopathic Medical College and General Hospital, Navsari
Near Devina Park Society Gandevi Road, Navsari Gujarat 396445 |
|
|
Primary Sponsor
|
| Name |
S. S. Agrawal Homoeopathic Medical College and General Hospital, Navsari |
| Address |
Near Devina Park Society Gandevi Road,Navsari Gujarat India 396445 |
| 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 |
| Shivani Kishnakant Rathod |
S. S. Agrawal Homoeopathic Medical College and Hospital, Navsari |
Medicine OPD and Gynaecology OPD, Ground floor ,
Near Devina Park Society Gandevi Road, Navsari Gujarat India 396445
Navsari
GUJARAT |
09913787052
shiva15rathod@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SSAHMC Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N309||Cystitis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Homoeopathic therapeutics and constitutional medicines applicable for cystitis. |
Homoeopathic medicines related to cystitis will be prescribed on the basis of individual totality of symptoms. The dose and potency will be selected on the basis of patient susceptibility and necessity of case. Administration will be through oral route and routine follow up will be taken. |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
All Diagnosed cases of age group between 18 years to 50 years of both sexes will be included. |
|
| ExclusionCriteria |
| Details |
Age below 18 years and above 50 years, Pregnant and lactating mother, Complicated cases with Advance pathology will be excluded. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in intensity after giving homeopathic medicine with the help of ACSS scale and ICSI scale as required |
9 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in recurrence of infection and over all well-being with the help of ACSS scale and ICSI scale as required |
12 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
|
N/A |
|
Date of First Enrollment (India)
|
01/09/2025 |
| 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="1"
Months="0"
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
|
This is a single centre randomized clinical study to understand the usefulness of Homoeopathic Medicine in Management of Urinary Tract Infection -Cystitis between age group of 18 to 50 years through clinical study. The study will be for duration of 12 months and the assessment will be done through ACSS scale and ICSI scale as needed to evaluate the reduction in intensity and reduction in recurrence of symptoms before and after treatment .Case taking will be done and on the basis of symptoms and reportorial totality and also as per therapeutic need medicine will be selected and prescribed as required |