| CTRI Number |
CTRI/2024/03/064643 [Registered on: 22/03/2024] Trial Registered Prospectively |
| Last Modified On: |
16/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Homeopathic treatment of stoppage of menses |
|
Scientific Title of Study
|
Efficacy of individualized homoeopathic medicines in the symptomatic improvement of menopausal syndrome: A double-blind, randomized, placebo-controlled trial |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1304-1117 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Manjeet Kaur |
| Designation |
Post Graduate Trainee |
| Affiliation |
D. N. De Homoeopathic Medical College and Hospital |
| Address |
Department of Organon of Medicine, OPD PG1 and room no. 4 Gynaecology OPD, 12, Gobinda Khatick Road, Tangra, Kolkata
Kolkata
WEST BENGAL
700046
India |
| Phone |
9891175855 |
| Fax |
|
| Email |
manjeetk632@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sangita Saha |
| Designation |
Professor |
| Affiliation |
D. N. De Homoeopathic Medical College and Hospital |
| Address |
Department of Organon of Medicine, OPD PG1 and room no. 4 Gynaecology OPD, 12, Gobinda Khatick Road, Tangra, Kolkata
Kolkata
WEST BENGAL
700046
India |
| Phone |
9433849505 |
| Fax |
|
| Email |
dr.sangita78@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sangita Saha |
| Designation |
Professor |
| Affiliation |
D. N. De Homoeopathic Medical College and Hospital |
| Address |
Department of Organon of Medicine, OPD PG1 and room no. 4 Gynaecology OPD, 12, Gobinda Khatick Road, Tangra, Kolkata
Kolkata
WEST BENGAL
700046
India |
| Phone |
9433849505 |
| Fax |
|
| Email |
dr.sangita78@gmail.com |
|
|
Source of Monetary or Material Support
|
| D. N. De Homoeopathic Medical College and Hospital, 12, Gobinda Khatick Road, Tangra, Kolkata 700046 |
|
|
Primary Sponsor
|
| Name |
D. N. De Homoeopathic Medical College and Hospital |
| Address |
12, Gobinda Khatick Road, Tangra, Kolkata 700046 |
| Type of Sponsor |
Government 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 Manjeet Kaur |
D. N. De Homoeopathic Medical College and Hospital |
Department of Organon of medicine, PG1 OPD and room no. 4 Gynaecology OPD, 12, Gobinda Khatick Road, Tangra, Kolkata 700046
Kolkata
WEST BENGAL |
9891175855
manjeetk632@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of D. N. De Homoeopathic Medical College & Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N951||Menopausal and female climactericstates, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Identical-looking placebo plus concomitant care |
This group will receive placebo, identical in appearance with the verum. Each dose will consist of 4 cane sugar globules no. 40 moistened with 90% v/v ethanol, to be taken orally on clean tongue with empty stomach; dosage and repetition will be maintained depending upon the individual requirement of the cases. All sundry items will be procured from a Good Manufacturing Practice (GMP) certified firm. All the enrolled patients will receive management advice such as pursuing a healthy lifestyle that includes a diet particularly rich in phytoestrogens (soybeans, whole grains, legumes, fruits, vegetables, etc.) and daily exercise (especially certain Hatha yoga asanas and Sudarshan Yoga Kriya). Duration of therapy: 4 months. |
| Intervention |
Individualized homoeopathic medicines in centesimal potencies plus concomitant care |
Intervention is planned as administering indicated homoeopathic medicines in centesimal potencies (CH). Each dose will consist of 4 cane sugar globules no. 40 moistened with the indicated medicine (preserved in 90% v/v ethanol), to be taken orally on clean tongue with empty stomach; dosage and repetition depending upon the individual requirement of the cases. Patients will be advised to refrain from handling the globules or from eating, drinking, smoking or brushing teeth within 30 minutes of taking the globules and will be asked to suck the globules rather than simply swallowing those. Single individualized medicine will be prescribed on each occasion taking into account presenting symptom totality, clinical history details, constitutional features, miasmatic expressions, repertorization using HOMPATH/RADAR software when required with due consultation of Materia Medica and due consensus among three homoeopaths. All the medicines and sundry items will be procured from a Good Manufacturing Practice (GMP) certified firm. Provision will be kept to change the medicines or potencies and adjust the dosage in subsequent visits whenever required following the principles of classical homoeopathy and such instances will be compared between groups. All the enrolled patients will receive management advice such as pursuing a healthy lifestyle that includes a diet particularly rich in phytoestrogens (soybeans, whole grains, legumes, fruits, vegetables, etc.) and daily exercise (especially certain Hatha yoga asanas and Sudarshan Yoga Kriya). Duration of therapy: 4 months. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Female |
| Details |
1. Patients suffering from Menopausal syndrome (ICD-11-GA30.0) presenting with symptoms (hot flashes, mood changes, vaginal dryness, sleep disturbances, etc.) of not less than 3 months of duration
2. Age between 40 and 55 years
3. Mild to moderate menopausal symptoms - MRS score mild 5-8, moderate 9-16
4. Participants having prior experience or knowledge of the treatment; e.g., primed to expect ‘homoeopathic aggravation’ and available treatment options for the disease conditions, intimated through Patient Information Sheet |
|
| ExclusionCriteria |
| Details |
1. Not willing to give informed consent or to comply with the study procedure.
2. Hysterectomy done and/or receiving any kind of hormone therapy.
3. Any life-threatening diseases or recently active physical disease.
4. In some condition when requiring emergency or surgical intervention.
5. Presence of uncontrolled medical conditions such as diabetes, hypertension, cardiac disorder & thyroid disorder.
6. Diagnosed cases of unstable mental or psychiatric illness or other uncontrolled or life-threatening illness affecting quality of life.
7. Undergoing homoeopathic treatment for any chronic disease within last six months.
8. Simultaneous participation in any other clinical trial.
9. Vulnerable population - Unconscious, non-ambulatory, too sick for consultation, differently abled, terminally ill or critically ill patients, mentally incompetent people.
10. Self-reported immune-compromised state.
11. Tobacco chewing and/or smoking, alcoholism and/or any other form(s) of substance abuse and/or dependence |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Menopause Rating Scale (MRS) |
Baseline, every month, up to 4 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Menopause specific quality of life questionnaire (MENQOL) |
Baseline, every month, up to 4 months |
| Measure Yourself Medical Outcome Profile version 2 (MYMOP-2) |
Baseline, every month, up to 4 months |
|
|
Target Sample Size
|
Total Sample Size="93"
Sample Size from India="93"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
01/04/2024 |
| 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="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
- 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.
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [manjeetk632@gmail.com].
- For how long will this data be available start date provided 01-01-2026 and end date provided 31-12-2030?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NA
|
|
Brief Summary
|
Menopause is the permanent cessation of menstruation for at least 12 consequent months. Although it is a physiological phenomenon, it is associated with a lot of troublesome symptoms such as hot flashes, palpitations, urogenital complaints, anxiety, disturbed sleep, etc., which have long term consequences to the overall health of a woman. Though homoeopathic medicines are used extensively to treat menopausal syndrome, diligent research evidence in favor of homoeopathy is not well marked. So, I intend to undertake the research to evaluate the efficacy and safety of homoeopathic medicines in the treatment of menopausal syndrome. A double-blind, randomized (2:1), placebo-controlled trial will be conducted on 93 women with menopausal syndrome at the OPD of D. N. De Homoeopathic Medical College and Hospital. Assessment will be done by evaluating the Menopause Rating Scale (MRS) as the primary outcome, Menopause specific quality of life questionnaire (MENQOL) and Measure Yourself Medical Outcome Profile version 2 (MYMOP-2) as the secondary outcomes. The primary as well as secondary outcomes will be evaluated every month, up to 4 months of intervention. Comparative analysis will be carried out on the Intention-To-Treat (ITT) and Per-Protocol (PP) basis to detect group differences. Results will be published in scientific journals. |