| CTRI Number |
CTRI/2025/10/096014 [Registered on: 13/10/2025] Trial Registered Prospectively |
| Last Modified On: |
09/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinical utility of synthesis 9.1 repertory in women suffering from urinary tract infection |
|
Scientific Title of Study
|
Clinical utility of synthesis 9.1 repertory in cases of urinary tract infection in women using visual analog scale (vas) for uti symptom assessment. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Deepika Bijendrakumar Shrivastav |
| Designation |
Pg scholar |
| Affiliation |
Anand Homoeopathic Medical College and Research Institute |
| Address |
room no.1, department of homeopathic medicine,Anand Homoeopathic Medical College and Research Institute and Anand Homoeopathic Hospital Near Sardar baug, Bhalej Road Anand-388001
Anand
GUJARAT
388001
India |
| Phone |
9879590441 |
| Fax |
|
| Email |
deepikashrivastav422@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Abhishek Udani |
| Designation |
Professor |
| Affiliation |
Anand Homoeopathic Medical College and Research Institute |
| Address |
room no.1, department of homeopathic medicine,Anand Homoeopathic Medical College and Research Institute and Anand Homoeopathic Hospital Near Sardar baug, Bhalej Road Anand-388001
Anand
GUJARAT
388001
India |
| Phone |
9978624694 |
| Fax |
|
| Email |
udaniabhishek@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Abhishek Udani |
| Designation |
Professor |
| Affiliation |
Anand Homoeopathic Medical College and Research Institute |
| Address |
room no.1, department of homeopathic medicine,Anand Homoeopathic Medical College and Research Institute and Anand Homoeopathic Hospital Near Sardar baug, Bhalej Road Anand-388001
Anand
GUJARAT
388001
India |
| Phone |
9978624694 |
| Fax |
|
| Email |
udaniabhishek@gmail.com |
|
|
Source of Monetary or Material Support
|
| Anand Homoeopathic Medical College and Research Institute and Anand Homoeopathic Hospital Anand Gujarat-388001 |
|
|
Primary Sponsor
|
| Name |
Deepika Brijendrakumar Shrivastav |
| Address |
616,hetal row house, ponsara maroli,jalalpore,navsari-396436 |
| Type of Sponsor |
Other [Self] |
|
|
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 Deepika Shrivastav |
Anand homeopathic hospital |
room no. 1, department of Homeopathic medicine, Opp. Sardar baug, Nr. New bus stand, Anand, Gujarat, 388001,India
Anand
GUJARAT |
9879590441
deepikashrivastav422@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, ANAND HOMEOPATHIC MEDICAL COLLEGE AND RESEARCH INSTITUTE |
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 |
Individualized homeopathic medicine |
The medicine will be prescribed after repertorising the case with help of synthesis 9.1 repertory the final choice will be made with the aid of materia medica.the potency 30c or 200 etc will be selected based on the susceptibility of the patients. And repetition will be done based on need of patient in solid globule form and duration of study will be 18 months |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1 Women aged 18-65 with urinalysis suggestive of at least 10 raise to 5 CFU/mL with symptomatic presentation presenting with symptoms of uncomplicated urinary tract infection within the past 48 hours able to give informed consent.
2 Patients who are willing to continue the treatment and follow-up according to protocol.
3 Female of all socioeconomic condition will be considered Patients willing to participate in study for their acute urinary tract infection will be considered.
4 Patients with recurrent cases of urinary tract infection. |
|
| ExclusionCriteria |
| Details |
1 Pregnant women, individuals with diabetes or kidney disease, those currently on antibiotics, and those patients where urinary tract infection is due to underlying advance pathology.
2 Patient suffering from any other systemic diseases like renal disease or other pathology.
Catheter induced urinary tract infection will be excluded in this study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Based on visual analog scale for uti |
At the baseline and at the end of each follow-ups |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
25/10/2025 |
| 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="6"
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 infections are bacterial infections anywhere along the urinary tract— from urethra to kidneys. Most are caused by uropathogenic E. coli, responsible for ~90% of cases in anatomically normal individuals. Urinary tract infections are subdivided into catheter-associated (or nosocomial) infections and non-catheter-associated (or community-acquired) infections. Infections in either category may be symptomatic or asymptomatic. Urinary tract infections are among the most prevalent infections globally and in India, with women and older adults most affected. The burden has been rising since 1990—driven by demographic trends and increasing antibiotic resistance. In India, high prevalence and resistance patterns are major concerns, particularly in community and vulnerable populations. A study is required for following reasons: 1. To limit the period of suffering. 2. To minimize the severity of suffering. 3. To arouse the immunity of the patient in order to prevent re-infection. |