| CTRI Number |
CTRI/2025/02/080955 [Registered on: 20/02/2025] Trial Registered Prospectively |
| Last Modified On: |
30/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Use Of Homoeopathy In Complaints Of Menopause |
|
Scientific Title of Study
|
Role Of Individualized Homoeopathic Medicine In
Post Menopausal Genitourinary Syndrome
By Using Synthesis Repertory:
An Open Label Prospective Clinical Study
|
| 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 Bobbili Lakshmi Mounica |
| Designation |
PGT Trainee |
| Affiliation |
National Institute Of Homoeopathy |
| Address |
OPD Room No 10, Department Of Case Taking And Repertory, National Institute Of Homoeopathy, Block GE, Sector III, Salt Lake, Kolkata
West Bengal
700106
India
Kolkata
WEST BENGAL
700106
India |
| Phone |
7901006184 |
| Fax |
|
| Email |
mounikabobbili777@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Birendra Prasad Srivastava |
| Designation |
Professor |
| Affiliation |
National Institute Of Homoeopathy |
| Address |
OPD Room No 10, Department Of Case Taking And Repertory, National Institute Of Homoeopathy, Block GE, Sector III, Salt Lake, Kolkata
West Bengal
700106
India
Kolkata
WEST BENGAL
700106
India |
| Phone |
7003178867 |
| Fax |
|
| Email |
dr.srivastava61@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Birendra Prasad Srivastava |
| Designation |
Professor |
| Affiliation |
National Institute Of Homoeopathy |
| Address |
OPD Room No 10, Department Of Case Taking And Repertory, National Institute Of Homoeopathy, Block GE, Sector III, Salt Lake, Kolkata
West Bengal
700106
India
WEST BENGAL
700106
India |
| Phone |
7003178867 |
| Fax |
|
| Email |
dr.srivastava61@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute Of Homoeopathy, Block GE, Sector III, Salt Lake, Kolkata, West Bengal, 700106, India |
|
|
Primary Sponsor
|
| Name |
National Institute Of Homoeopathy |
| Address |
National Institute Of Homoeopathy, Block GE, Sector III, Salt Lake, Kolkata, West Bengal, 700106, India |
| 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 Bobbili Lakshmi Mounica |
National Institute Of Homoeopathy |
OPD Room No 10, Department Of Case Taking And Repertory, Block GE, Sector III, Salt Lake
Kolkata
WEST BENGAL |
7901006184
mounikabobbili777@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| National Institute Of Homoeopathy |
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 |
| Intervention |
Individualized Homoeopathic Medicine |
Individualized homoeopathic medicine will be prescribed after the proper case taking and repertorisation of the case using rubrics within synthesis repertory. Dose and frequency of the selected medicine will be as per the susceptibility of the case. Follow up will be done monthly till 6 months from the baseline. |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
1. Female patients between 40-60 years of age having natural menopause with 12 months of amenorrhea, clinically diagnosed with Genitourinary Syndrome of Menopause using the Vulvovaginal Symptom Questionnaire (VSQ).
2. Female patients of all socio-economic status and all religions.
3. Willingness to actively participate in the study, attend regular follow-up assessments, and
adhere to the prescribed homeopathic treatment plan.
4. Patients who can read/understand Hindi, English, or Bengali.
5. Female patients with known but controlled systemic diseases.
6. Stable overall health without acute or severe medical conditions.
|
|
| ExclusionCriteria |
| Details |
1. Female Patients who have undergone Hysterectomy.
2. Female patients who are having malignant diseases
3. Female patients using any medicine or hormone therapy containing oestrogen and progesterone since 3months.
4. Female patients suffering from any life threatening/ psychiatric illness or immune
compromised state.
5. Female patients who are on substance abuse or dependence.
6. Dermatological conditions of vulva such as lichen sclerosus or planus, eczema, dermatitis; Vulvodynia; Vaginosis; Chronic vulvovaginitis.
7. Inability or unwillingness to comply with scheduled follow-up visits and assessments
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Vulvovaginal Symptom Questionnaire (VSQ21) |
Baseline & 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Socio-demographic data |
After 6 months |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
25/02/2025 |
| 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="1"
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 - NO
|
|
Brief Summary
|
Genitourinary syndrome of menopause (GSM), formerly called vulvovaginal
atrophy, atrophic vaginitis or urogenital atrophy, is a chronic condition that
affects the vulvovaginal area, sexual function, and lower urinary tract. GSM includes a spectrum of symptoms that affect both the genital and
urinary systems, manifesting as vaginal dryness, irritation, dyspareunia (pain
during intercourse), urinary incontinence, and recurrent urinary tract
infections.
1. Samples will be selected following preliminary and detailed screening using specified selection criteria. 2. Inclusion and exclusion criteria are strictly followed. 3. After consideration of dropout cases, a minimum 40 patients will be enrolled for the study. 4. Case-taking will be done as per the strict homoeopathic principle. 5. Baseline scoring will be taken using VSQ21. 6. Analysis and evaluation of each case will be done. 7. Miasmatic analysis will be done. 8. Repertorization will be done in Synthesis Repertory. 9. Final selection of the remedy will be done after consultation with Materia Medica. 10. Potency, dose and repetition of the indicated remedies will be guided strictly as per homoeopathic principles. 11. General (non-medicinal) management including appropriate diet and regimen will be advised. 12. Subsequent prescriptions (follow-ups) will be generated according to relevant homoeopathic principles and will be recorded in follow-up sheets. 13. The baseline data will be compared with the data obtained after 6 months. 14. The score obtained by the patients will be compared and result will be analyzed as per appropriate statistical methods and interference will be done thereafter. |