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CTRI Number  CTRI/2024/07/069767 [Registered on: 01/07/2024] Trial Registered Prospectively
Last Modified On: 20/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Homeopathy 
Study Design  Single Arm Study 
Public Title of Study   Homoeopathic management in menopausal syndrome 
Scientific Title of Study   A Case Series Study on exploring the potential benefits of Homoeopathic medicine Sanguinaria canadensis in alleviating Menopausal Syndrome and enhancing Quality of life 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  X Jemima Grace 
Designation  PG Scholar 
Affiliation  White memorial Homoeo Medical College and Hospital 
Address  Department of Materia Medica, White Memorial Homoeo Medical College and Hospital, Attoor, Veeyanoor (po), Kanniyakumari district
Department of Materia Medica, White Memorial Homoeo Medical College and Hospital, Attoor, Veeyanoor (po), Kanniyakumari district
Kanniyakumari
TAMIL NADU
629177
India 
Phone  9047253412  
Fax    
Email  jemigray04@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. K. Manikanda Perumal 
Designation  Head of Department 
Affiliation  WHITE MEMORIAL HOMOEO MEDICAL  
Address  Department of Materia Medica, White Memorial Homoeo Medical College and Hospital, Attoor, Veeyanoor (po), Kanniyakumari district
Department of Materia Medica, White Memorial Homoeo Medical College and Hospital, Attoor, Veeyanoor (po), Kanniyakumari district
Kanniyakumari
TAMIL NADU
629177
India 
Phone  9787925186  
Fax    
Email  dr.perumal007@gmail.com  
 
Details of Contact Person
Public Query  
Name  X Jemima Grace 
Designation  PG Scholar 
Affiliation  WHITE MEMORIAL HOMOEO MEDICAL  
Address  Department of Materia Medica, White Memorial Homoeo Medical College and Hospital, Attoor, Veeyanoor (po), Kanniyakumari district
Department of Materia Medica, White Memorial Homoeo Medical College and Hospital, Attoor, Veeyanoor (po), Kanniyakumari district
Kanniyakumari
TAMIL NADU
629177
India 
Phone  9047253412  
Fax    
Email  jemigray04@gmail.com  
 
Source of Monetary or Material Support  
Department of Materia Medica, White memorial Homoeo Medical College and Hospital, Attoor, Veeyanoor (po), Kanniyakumari district, Tamil nadu, India 
 
Primary Sponsor  
Name  White memorial Homoeo Medical College and Hospital 
Address  Department of Materia Medica, White memorial Homoeo Medical College and Hospital, Attoor, Veeyanoor (po), Kanniyakumari district, Tamil nadu, India - 629177  
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 X Jemima Grace  White Memorial Homoeo Medical College and Hospital   Department of Materia Medica OPD unit, IPD unit, Health campus and Peripheral centers, Attoor
Kanniyakumari
TAMIL NADU 		 9047253412

jemigray04@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee White Memorial Homoeo Medical College and Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N951||Menopausal and female climactericstates,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Homoeopathic medicine - Sanguinaria canadensis  Each case will be reviewed at 2 weeks interval and it will be followed up for a period of 10 months 
Intervention  Homoeopathic medicine - Sanguinaria canadensis  Potency selection is based on susceptibility of the participant, Dose is minimum dose, Routes of administration is oral for a period of 2 weeks until next follow up 
Comparator Agent  not applicable  not applicable 
 
Inclusion Criteria  
Age From  45.00 Year(s)
Age To  55.00 Year(s)
Gender  Female 
Details  Participants who are Married women who undergo Menopause which had to be natural and not surgically or artificially induced and with the clinical history and manifestations of menopausal syndrome
 
 
ExclusionCriteria 
Details  Participants under hormone replacement therapy or any other treatment for menopausal syndrome, participants undergone bilateral oophorectomy or total hysterectomy and under any chemotherapy drug treatment or other process that has resulted in menopausal syndrome 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The intensity of complaints is assessed by menopause rating scale, the score ranging
from 0 – 4
The Quality of life will be assessed by WHO Quality of life scale – Brief 		 6 months  
 
Secondary Outcome  
Outcome  TimePoints 
After completion of study
The intensity of complaints are assessed by menopause rating scale, the score ranging
from 0 – 4
The Quality of life will be assessed by WHO Quality of life scale – Brief 		 1 year 
 
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   Phase 2 
Date of First Enrollment (India)   01/07/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  01/07/2024 
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

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

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  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 - Proposals should be directed to [jemigray04@gmail.com].

  6. For how long will this data be available start date provided 25-12-2025 and end date provided 25-12-2030?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   A minimum of 30 cases will be selected for the study by purposive sampling
Cases will be taken in detail and recorded in the structured case sheet formulated for the study
Diagnosis will be done by history and clinical presentation
The intensity of complaints will be assessed by Menopause Rating Scale
The quality of life will be assessed by WHO Quality of life scale – Brief
Homoeopathic medicine, Sanguinaria canadensis will be administered to minimum of 30 cases
Counselling will be given in needed cases
Follow up will be done once in 15 days for the report or as per their need in case of an emergency
Result will be assessed by pre and post treatment. 
 
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