| CTRI Number |
CTRI/2026/04/108050 [Registered on: 09/04/2026] Trial Registered Prospectively |
| Last Modified On: |
07/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Homeopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Study to Compare the Effectiveness of Copaiva Officinalis and Individualised Homoeopathic Treatment in Patients with Urinary Tract Infection (Age 20–60 Years) |
|
Scientific Title of Study
|
A comparative evaluation on the effectiveness of Copaiva Officinalis and Individualised Homoeopathic Medicines in the symptomatic management of Urinary tract infection in age group of 20-60 years |
| 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 Arunima V P |
| Designation |
Post graduate student |
| Affiliation |
Government Homoeopathic Medical College,Iranimuttom,Thiruvananthapuram-695009 |
| Address |
SURABHI
Ayirooppara
Pothencode P O
Thiruvananthapuram
Department of Materia Medica
Government Homoeopathic Medical College,Iranimuttom,Thiruvananthapuram-695009
Thiruvananthapuram
KERALA
695584
India |
| Phone |
8304034642 |
| Fax |
|
| Email |
arunimapravada@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nisha M |
| Designation |
Guide Professor |
| Affiliation |
Government Homoeopathic Medical College,Iranimuttom,Thiruvananthapuram-695009 |
| Address |
Professor
Department of Materia Medica
Government Homoeopathic Medical College,Iranimuttom,Thiruvananthapuram
Department of Materia Medica
Government Homoeopathic Medical College,Iranimuttom,Thiruvananthapuram-695009
Thiruvananthapuram
KERALA
695009
India |
| Phone |
9846319984 |
| Fax |
|
| Email |
nisha_nizam@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Arunima V P |
| Designation |
Post graduate student |
| Affiliation |
Government Homoeopathic Medical College,Iranimuttom,Thiruvananthapuram-695009 |
| Address |
SURABHI
Ayirooppara
Pothencode P O
Thiruvananthapuram
Department of Materia Medica
Government Homoeopathic Medical College,Iranimuttom,Thiruvananthapuram-695009
Thiruvananthapuram
KERALA
695584
India |
| Phone |
8304034642 |
| Fax |
|
| Email |
arunimapravada@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Homoeopathic Medical College,Iranimuttom,Thiruvananthapuram-695009 |
|
|
Primary Sponsor
|
| Name |
Dr Arunima V P |
| Address |
PG Scholar
Department of Materia Medica
Government Homoeopathic Medical College
Iranimuttom
Thiruvananthapuram
695009 |
| 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 Arunima V P |
Government Homoeopathic Medical College,Iranimuttom,Thiruvananthapuram |
OP NO.1
Hospital Building
Materia Medica Department
Thiruvananthapuram
KERALA |
8304034642
arunimapravada@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Government Homoeopathic Medical College,Iranimuttom,Thiruvananthapuram |
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 |
COPAIVA OFFICINALIS 30 C |
Copaiva Officinalis 30 C is administered to group A orally(3 to 4 globules thrice daily ) |
| Comparator Agent |
INDIVIDUALISED HOMOEOPATHIC MEDICINES |
Individualised Homoeopathic Medicines to group B orally |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients with urine containing pus cells more than 0 to 5 per HPF
Both men and women are included in the study
Age between 20 to 60 years old
All socioeconomic groups |
|
| ExclusionCriteria |
| Details |
Individuals with severe systemic illness
Lactating and pregnant women
Infants and old aged people |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the effects of homoeopathic medicine Copaiva officinalis with
individualised Homoeopathic medicines in patients with UTI ,assessed by SHU
Score |
Each case will be reviewed at 2 weeks interval and followed for a minimum period of
6 months.Outcome will be assessed by comparing SHU Score at the beginning, third and the end of 6
months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)To determine whether there is symptomatic improvement and changes in SHU
Score in individuals with UTI after treatment with the Homoeopathic medicine
Copaiva officinalis.
2)To determine whether there is symptomatic improvement and changes in SHU
Score in individuals with UTI after treatment with the individualised
Homoeopathic medicines. |
Each case will be reviewed at 2 weeks interval and followed for a minimum period of
6 months.Outcome will be assessed by comparing SHU Score at the beginning, third and the end of 6
months. |
|
|
Target Sample Size
|
Total Sample Size="54"
Sample Size from India="54"
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 4 |
|
Date of First Enrollment (India)
|
05/05/2026 |
| 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 Yet Recruiting |
| 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
|
A prospective quasi experimental study will be conducted at the Government Homoeopathic Medical College, Thiruvananthapuram over a period of one year.54 patients (both male and female) aged between 20 to 60 years with Urinary tract infection confirmed by urine microscopy with pus cells more than 0-5/HPF in all socioeconomic group is selected and divided into two groups. One group will be given (A) Copaiva Officinalis and other (B) Individualised Homoeopathic medicines. The study aims to evaluate and compare the effectiveness of Copaiva Officinalis and Individualised Homoeopathic medicines in managing Urinary tract infection. |