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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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
  1. 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).

  2. What additional supporting information will be shared?
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) -  All the data to be provided when needed through email iswaryah01@gmail.com

  6. 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.

  7. 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.

 
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