| CTRI Number |
CTRI/2025/02/080236 [Registered on: 10/02/2025] Trial Registered Prospectively |
| Last Modified On: |
07/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Role of Kent Repertory in menopausal age group on psychological aspect |
|
Scientific Title of Study
|
Role of Kent Repertory in menopausal age group with special emphasis on psychological aspect
Assessed by MRS (Menopause Rating Scale)
|
| 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 MANISHA PARMAR |
| Designation |
PG SCHOLAR |
| Affiliation |
Smt A J Savla Homoeopathic Medical College and Research Institute |
| Address |
Department of Gynecology and Obstetric Room no 4 Ground Floor Smt A J Savla Homoeopathic Medical College and Research Institute Pushpanjali Building Near District Session Court Mehsana
Mahesana
GUJARAT
384001
India |
| Phone |
9328855088 |
| Fax |
|
| Email |
manishapatel17112018@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neha I Patel |
| Designation |
Professor, PG Coordinator |
| Affiliation |
Smt A J Savla Homoeopathic Medical College and Research Institute |
| Address |
Department Of Repertory PG PG Building First Floor room no 14 Smt A J Savla Homoeopathic Medical College and Research Institute Pushpanjali Building Near District Session Court Mehsana
Mahesana
GUJARAT
384001
India |
| Phone |
9428458613 |
| Fax |
|
| Email |
drnehpatel13@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR MANISHA PARMAR |
| Designation |
PG SCHOLAR |
| Affiliation |
Smt A J Savla Homoeopathic Medical College and Research Institute |
| Address |
Department of Gynecology and Obstetric Room no 4 Ground Floor Smt A J Savla Homoeopathic Medical College and Research Institute Pushpanjali Building Near District Session Court Mehsana
Mahesana
GUJARAT
384001
India |
| Phone |
9328855088 |
| Fax |
|
| Email |
manishapatel17112018@gmail.com |
|
|
Source of Monetary or Material Support
|
| Smt. A J Savla Homoeopathic Medical College and Research Institute Pushpanjali Building Near District Court Mehsana Gujarat 384001 |
|
|
Primary Sponsor
|
| Name |
Dr Manisha Parmar |
| Address |
Department of Gynecology and Obstetrics Room no 4 ground floor Smt A J Savla Homoeopathic Medical College and Research Institute Pushpanjali Building Near District Session Court Mehsana Gujarat 384001 |
| Type of Sponsor |
Other [Self ] |
|
|
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 Manishaben B Parmar |
Smt A J Savla Homoeopoathic Medical College and Research Institute |
Department of Gynecology and Obstetric Room no 4 Ground Floor Smt A J Savla Homoeopathic Medical College and Research Institute Pushpanjali Building Near District Session Court Mehsana
Mahesana
GUJARAT |
9328855088
manishapatel17112018@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Smt A J Savla Homoeopathic Medical College and research Institute Institutional Ethical committee |
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 medicine |
Potency Decimal Centesimal various as per need Dose as per need of case Frequency as per need of case Route of administration oral route Duration of therapy 8 month as per need of case |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
Clinically diagnosed cases of menopause
Natural menopause with 12 consecutive months of amenorrhea
Women between 45 to 60 years of age
Experiencing prominent psychological symptoms related to menopause such as Anxiety Depression Mood swings Irritability Ability to fill MRS and willing to give consent for the study MRS between 5 to 16 score
|
|
| ExclusionCriteria |
| Details |
Cases having irreversible pathology like uterine pathology
Patients who are taking any other mode of treatment like Allopathic Ayurvedic Homoeopathic
Patient with severe chronic diagnosed Psychiatric illness before menopausal age
Patient with suicidal tendency
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Menopause Rating Scale to assess reduction in psychological aspect in menopausal woman |
Menopause Rating Scale will be assessed at baseline and end of treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
18/02/2025 |
| 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
|
This study is a prospective study Pre test Post test one group experimental study to asses the role of Kent repertory in Psychological aspect in menopausal age between 45 to 60 age for 8 month duration in the 30 participants that will be included as per inclusion and exclusion criteria from out department patient Outcome measures will be asses with Menopausal Ratting Scale at the base line and after the treatment Patient follow up as per need of patient at every 15 days up to 8 month |