| 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
|
|
|
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
|
|
|
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
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- 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
- 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 - Proposals should be directed to [bravemaha@gmail.com].
- 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.
- 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. |