| CTRI Number |
CTRI/2025/07/091367 [Registered on: 22/07/2025] Trial Registered Prospectively |
| Last Modified On: |
21/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Study On The Role Of A Homoeopathic Method In Managing Stress And Mood Changes In Menopausal Women |
|
Scientific Title of Study
|
Evaluating The Utility Of Kent Repertory In Menopausal Age Group With Special Emphasis On Psychological Aspect. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ayushi Sandipbhai Desai |
| Designation |
MD Part 2 |
| Affiliation |
C.D.Pachchigar College Of Homoeopathic Medicine And Hospital |
| Address |
C.D.Pachchigar College Of Homoeopathic Medicine And Hospital Department Of Case Taking And Repertory Post Graduation Division 2nd Floor Near Navjivan Circle Udhna Magdalla Road Surat
Surat
GUJARAT
395001
India |
| Phone |
7016701935 |
| Fax |
|
| Email |
asdesai499@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shrirang N Vyas |
| Designation |
M.D. (Hom.) |
| Affiliation |
C.D.Pachchigar College Of Homoeopathic Medicine And Hospital |
| Address |
C.D.Pachchigar College Of Homoeopathic Medicine And Hospital Department Of Case Taking And Repertory Post Graduation Division 2nd Floor Near Navjivan Circle Udhna Magdalla Road Surat
Surat
GUJARAT
395001
India |
| Phone |
9426185880 |
| Fax |
|
| Email |
drsnvyas@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shrirang N Vyas |
| Designation |
M.D. (Hom.) |
| Affiliation |
C.D.Pachchigar College Of Homoeopathic Medicine And Hospital |
| Address |
C.D.Pachchigar College Of Homoeopathic Medicine And Hospital Department Of Case Taking And Repertory Post Graduation Division 2nd Floor Near Navjivan Circle Udhna Magdalla Road Surat
Surat
GUJARAT
395001
India |
| Phone |
9426185880 |
| Fax |
|
| Email |
drsnvyas@gmail.com |
|
|
Source of Monetary or Material Support
|
| C.D. Pachchigar College Of
Homoeopathic Medicine
And Hospital Near
Navjivan Circle Udhana
Magdalla Road Surat India 395001 |
|
|
Primary Sponsor
|
| Name |
C D Pachchigar College Of Homoeopathic Medicine And Hospital |
| Address |
D Pachchigar college of homoeopathic medicine and Hospital Near Navjivan Circle Udhana Magdalla Road Surat Gujarat India |
| 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 Ayushi Sandipbhai Patel |
C D Pachchigar College Of Homoeopathic Medicine And Hospital |
Department Of Case Taking And Repertory Post Graduation Division 2nd Floor
Surat
GUJARAT |
7016701935
asdesai499@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Of C. D. Pachchigar College Of Homoeopathic Medicine And 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 |
| Intervention |
Homoeopathic Medicines |
Homoeopathic Medicines Will Be Prescribed On The Basis of Totality Of Symptoms And Individual Susceptibility The Medicine Will Be Administered Orally In The Form Of Sugar Of Milk And Will Be Repeated According To Need Of Case The Total Duration Of Interveention Will Be For 15 To 30 Days |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
1.Women between 40-60 years of age.
2.Clinically diagnosed cases of menopause.
3.Women with history of hysterectomy. |
|
| ExclusionCriteria |
| Details |
1.Cases where oophorectomy has been performed.
2.Women who are undergoing hormone replacement therapy. |
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To Study Utility Of Kent Repertory In Menopausal Women. |
9 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To Study Efficacy Of Homoeopathic Medicines In Psychological Effects Of Menopause. |
9 Months |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
01/08/2025 |
| 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="0"
Months="9"
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
|
Aim of StudyTo evaluate the usefulness of Kent Repertory in managing psychological symptoms associated with menopause through homoeopathic remedies. Need for Study- Menopause brings both physical and psychological symptoms like depression, anxiety, mood swings, irritability, low confidence.
- 20 per of women experience depression during perimenopause.
- With a growing number of post-menopausal women in India, studying this phase holistically is crucial.
- Dr. Kent’s emphasis on mental and physical generals aligns with the individualized approach of homoeopathy. Objectives1. Study the application of Kent Repertory in menopausal women. 2. Assess the effectiveness of homoeopathic medicines for psychological symptoms during menopause. Literature Highlights- Menopause is the permanent cessation of menstruation.
- Symptoms: hot flushes, urogenital atrophy, cardiovascular issues, mood disorders, etc.
- Menopausal transition often correlates with psychiatric symptoms.
- Estrogen fluctuations can influence neurotransmitters serotonin, norepinephrine, contributing to depression and anxiety.
- Kent’s Repertory follows a general-to-particular approach, emphasizing mental symptoms and is organized alphabetically. Methodology- Study Type: Prospective analytical study
- Sample Size: 30 cases
- Data Source: OPD/IPD at C.D. Pachchigar Hospital & peripheral OPDs
- Tools Used:
* Kent’s Repertory
* Likert scale to assess severity of menopausal symptoms
* Case format based on Hahnemann’s guidelines Aphorism 83–104
- Inclusion Criteria:
* Women aged 40–60 years with natural or surgical menopause excluding oophorectomy
- Exclusion Criteria:
* Hormone replacement therapy users
* Irregular follow-ups or discontinued treatment Outcome Measurement- Symptom severity rated using the Likert scale across three categories:
* Psychological depression, anxiety, etc.
* Somato-vegetative hot flushes, joint pain, etc.
* Urogenital sexual and bladder problems
- Severity scored from 0 none to 4 severe |