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CTRI Number  CTRI/2024/08/072378 [Registered on: 12/08/2024] Trial Registered Prospectively
Last Modified On: 09/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Homeopathy
Preventive 
Study Design  Single Arm Study 
Public Title of Study   Role of Homoeopathic Individualized Medicine in the management of Post Menopausal Syndrome 
Scientific Title of Study   Role of Homoeopathic Individualized Medicine in the management of Post Menopausal Syndrome 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Mahalakshumi H 
Designation  PG scholar 
Affiliation  White Memorial Homoeopathic Medical College and Hospital 
Address  Department of organon of medicine and Homoeopathic Philosophy, white memorial homoeopathic medical college and hospital, Chevaracode, Attoor, Kanniyakumari-629177

Kanniyakumari
TAMIL NADU
629177
India 
Phone  8220755070  
Fax    
Email  bravemaha@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  INDU.P  
Designation  Head of department 
Affiliation  White Memorial Homoeopathic Medical College and Hospital 
Address  Department Of Organon of Medicine & Homoeopathic Philosophy,white memorial homoeopathic medical college and hospital, Chevaracode, Attoor, Kanniyakumari-629177

Kanniyakumari
TAMIL NADU
629177
India 
Phone  9495704030  
Fax    
Email  indusujan9495@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Mahalakshumi H 
Designation  PG scholar 
Affiliation  White Memorial Homoeopathic Medical College and Hospital 
Address  Department Of Organon of Medicine & Homoeopathic Philosophy, white memorial homoeopathic medical college and hospital, Chevaracode, Attoor, Kanniyakumari-629177

Kanniyakumari
TAMIL NADU
629177
India 
Phone  8220755070  
Fax    
Email  bravemaha@gmail.com  
 
Source of Monetary or Material Support  
white memorial homoeopathic medical college and hospital, Chevaracode, Attoor, Kanniyakumari-629177 
 
Primary Sponsor  
Name  white memorial homoeopathic medical college and hospital 
Address  white memorial homoeopathic medical college and hospital, Chevaracode, Attoor, Kanniyakumari-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 Mahalakshumi H  White memorial homoeopathic medical college ans hospital  White memorial homoeopathic medical hospital,IPD, OPD of Department Of Organon of Medicine & Homoeopathic Philosophy, Chevaracode, Attoor, Kanniyakumari-629177
Kanniyakumari
TAMIL NADU 
8220755070

bravemaha@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee White Memorial Homoeopathic Medical College  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: PCS||,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Individualised homoeopathic medicine   in globules/ sac lac in suitable potency (30c/200c/50 millicimal potency) based on criteria for potency selection of the patient, 1 dose-once 30 days for 6 months, oral administation of globules. 
 
Inclusion Criteria  
Age From  45.00 Year(s)
Age To  60.00 Year(s)
Gender  Female 
Details  Females who have attained menopause and are above 45 are included
Climacteric female suffering from postmenopausal syndrome are included
Complications due to menopause are included
 
 
ExclusionCriteria 
Details  Females affected with other systemic and autoimmune illness are excluded
Females undergone hysterectomy and oophorectomy are not included
Female psychiatric illness is excluded
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Change in clinical signs and symptoms

 
Minimum period of 6 months and maximum period of 1 year  
 
Secondary Outcome  
Outcome  TimePoints 
Reduction in The Menopause-Specific Quality of Life Questionnaire (MENQOL)
Change in general wellbeing & mental state
 
Minimum period of 6 months & maximum period of 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 4 
Date of First Enrollment (India)   25/08/2024 
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 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 - 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 -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

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

  6. For how long will this data be available start date provided 08-02-2024 and end date provided 08-02-2029?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary   ROLE OF HOMOEOPATHIC INDIVIDUALIZED MEDICINE IN THE MANAGEMENT OF POST MENOPAUSAL SYNDROME.

Menopause is defined retrospectively as the time of the final menstrual period, followed by 12 months of amenorrhea. Post-menopause describes the period following the final menses.  Menopause (ICD-11 GA30. 00) is the permanent cessation of menstruation resulting in the loss of ovarian follicle development. Post-menopause syndrome can often go unrecognized, with many patients dismissing its symptoms as just a normal part of aging, unaware of its potential impact on their well-being. Unbeknownst to many, post-menopause syndrome encompasses a range of symptoms, including hot flashes, mood swings, fatigue, and changes in libido, among others. Ignoring these signs can lead to unnecessary discomfort and affect one’s quality of life. Seeking medical guidance and support can empower individuals to better manage these symptoms and enjoy a healthier post-menopausal journey.The Menopause Symptoms Treatment Satisfaction Questionnaire (MS-TSQ) is a tool designed to assess satisfaction with treatments for menopausal symptoms. It typically consists of questions related to the effectiveness of treatments, their side effects, ease of use, and overall satisfaction.In conclusion, studying the role of homoeopathic individualized medicine in the management of postmenopausal syndrome is to justify the need for safe, effective, and personalized treatment options that address the diverse symptoms experienced by women during this transitional phase of life. Such research has the potential to contribute to a more comprehensive understanding of complementary and alternative approaches to women’s health and improve patient-centered care in the management of postmenopausal symptoms.


 
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