| CTRI Number |
CTRI/2025/09/094480 [Registered on: 09/09/2025] Trial Registered Prospectively |
| Last Modified On: |
09/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to Evaluate the Effect of Homoeopathic medicine Sepia Officinalis in Postmenopausal Women with Recurrent Urine Infections |
|
Scientific Title of Study
|
A CLINICAL STUDY ON THE EFFECTIVENESS OF HOMOEOPATHIC MEDICINE SEPIA OFFICINALIS IN THE TREATMENT OF RECURRENT CYSTITIS
IN POSTMENOPAUSAL WOMEN |
| 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 ISWARYA H |
| Designation |
Junior Resident, Department of Homoeopathic Materia Medica |
| Affiliation |
White Memorial Homoeo Medical College and Hospital |
| Address |
Department of Homoeopathic Materia Medica,White Memorial Homoeo Medical College and Hospital,Attoor,Veeyanoor, Kanniyakumari
Kanniyakumari TAMIL NADU 629177 India |
| Phone |
9003646682 |
| Fax |
|
| Email |
iswaryah01@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr PRASOBH MP |
| Designation |
PROFESSOR,Department of Homoeopathic Materia Medica |
| Affiliation |
White Memorial Homoeo Medical College and Hospital |
| Address |
Department of Homoeopathic Materia Medica,White Memorial Homoeo Medical College and Hospital,Attoor,Veeyanoor, Kanniyakumari
Kanniyakumari TAMIL NADU 629177 India |
| Phone |
9447746688 |
| Fax |
|
| Email |
drprasobhmp@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr PRASOBH MP |
| Designation |
PROFESSOR,Department of Homoeopathic Materia Medica |
| Affiliation |
White Memorial Homoeo Medical College and Hospital |
| Address |
Department of Homoeopathic Materia Medica,White Memorial Homoeo Medical College and Hospital,Attoor,Veeyanoor, Kanniyakumari
TAMIL NADU 629177 India |
| Phone |
9447746688 |
| Fax |
|
| Email |
drprasobhmp@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Homoeopathic Materia Medica, White Memorial Homoeo Medical College and Hospital, Attoor, Veeyanoor, Kanyakumari,Tamilnadu |
|
|
Primary Sponsor
|
| Name |
Department of Homoeopathic Materia Medica, White Memorial Homoeo Medical College and Hospital |
| Address |
White Memorial Homoeo Medical College and Hospital, Attoor, Veeyanoor, Kanyakumari |
| 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 ISWARYA H |
WHITE MEMORIAL HOMOEO MEDICAL COLLEGE & HOSPITAL |
Department of Homoeopathic Materia medica OPD unit, IPD unit, Health camps and peripheral centers, Kanniyakumari Kanniyakumari TAMIL NADU |
9003646682
iswaryah01@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| WHITE MEMORIAL HOMOEO MEDICAL COLLEGE & HOSPITAL ETHICS COMMITTEE WMHMCH-EC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N308||Other cystitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Sepia officinalis |
Homoeopathic medicine Sepia officinalis will be administered to the selected cases.
Follow-up will be conducted weekly during the acute episode until symptom resolution. After that follow-up will continue every two weeks and additionally whenever necessary, for up to six months, to monitor for recurrence.
|
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Female |
| Details |
Postmenopausal status (12 or more than 12 months of amenorrhea)
Patients with more than 1 episodes of acute uncomplicated cystitis in the last 6 months.
ACSS score of 6 or more used as the cutoff for diagnosis and confirmed by urine analysis and urine culture. |
|
| ExclusionCriteria |
| Details |
Complicated UTIs, including Pyelonephritis, UTI with kidney stones, structural abnormalities, or catheters.
History of diabetes mellitus or immunosuppressive conditions affecting UTI susceptibility.
Use of antibiotics or other medications for UTI within the last 2 weeks
before enrollment.
Severe renal impairment or chronic kidney disease. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
The effectiveness of the Homoeopathic medicine Sepia officinalis will be evaluated based on the percentage reduction in the Acute Cystitis Symptom Score from pre-treatment to post treatment.
Outcome will be classified as follows:
Mild improvement: 1 – 33%
Moderate improvement: 34 – 66%
Marked improvement: 67 – 99%
|
6 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
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)
|
01/10/2025 |
| 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="0" 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Statistical Analysis Plan Response - Informed Consent Form Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) - All the data to be provided when needed through email iswaryah01@gmail.com
- For how long will this data be available start date provided 01-01-2028 and end date provided 01-01-2033?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
· Recurrent cystitis is a prevalent urological condition, particularly in postmenopausal women, affecting their quality of life, daily activities, and mental well-being. Recurrent lower urinary tract infections are common after the menopause and occur in more than 10 percentage of women over the age of 60. Due to estrogen deficiency there is rise in vaginal pH promotes an alteration in the normal vaginal flora, with decreased lactobacilli leading to increased colonization by pathogenic faecal flora. This increases the incidence of urinary tract infections in postmenopausal women. Recurrent UTI refers to a group of patients who have suffered from a UTI at least three times in the last 12 months or at least two times during the previous 6 months and have diminished quality of life. The purpose of this study is to do a systematic clinical evaluation of Sepia officinalis in the treatment of recurrent cystitis in postmenopausal women. The validated Acute Cystitis Symptom Score will be used as an evaluation assessment tool to measure the degree of improvement and symptom severity after homoeopathic treatment. The objective of my study is to assess whether individualized Sepia officinalis therapy can effectively reduce the frequency and severity of recurrent cystitis episodes, and to evaluate improvement using a validated symptom-based scale. A minimum of 30 postmenopausal women with recurrent cystitis will be selected from OPD, IPD, and peripheral centers of White Memorial Homoeopathic Medical College and Hospital. Detailed case records as per the approved format will be maintained, and diagnosis will be confirmed using clinical history and the Acute Cystitis Symptom Score supported by clinical examination and urine tests when needed. Sepia officinalis will be prescribed and patients will be followed weekly during acute episodes, then every two weeks or as required for six months. Improvement will be assessed by comparing pre and post treatment ACSS scores. The effectiveness of the Homoeopathic medicine Sepia officinalis will be evaluated based on the percentage reduction in the Acute Cystitis Symptom Score from pre-treatment to post treatment. |