| CTRI Number |
CTRI/2025/09/094393 [Registered on: 08/09/2025] Trial Registered Prospectively |
| Last Modified On: |
08/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Homoeopathic management of menopause in women of age group 45 to 55 years |
|
Scientific Title of Study
|
Evaluating the Role of Boger Boenninghausen’s Characteristics Repertory in the Management of Menopause in the Age Group 45-55 Years |
| 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 Khyati Pundir |
| Designation |
PG student |
| Affiliation |
PG Scholar Department of Repertory Dr D Y Patil Homoeopathic Medical College and Research Centre |
| Address |
PG Scholar Department of Repertory Dr D Y Patil Homoeopathic Medical College and Research Centre Sant Tukaram Nagar Pimpri Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9680038050 |
| Fax |
|
| Email |
khyati.pundiri8431@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Khyati Pundir |
| Designation |
PG student |
| Affiliation |
PG Scholar Department of Repertory Dr D Y Patil Homoeopathic Medical College and Research Centre |
| Address |
PG Scholar Department of Repertory Dr D Y Patil Homoeopathic Medical College and Research Centre Sant Tukaram Nagar Pimpri Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9680038050 |
| Fax |
|
| Email |
khyati.pundiri8431@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manish Arya |
| Designation |
Professor |
| Affiliation |
Professor Department of Repertory Dr D Y Patil Homoeopathic Medical College and Research Centre9422 |
| Address |
Professor Department of Repertory Dr D Y Patil Homoeopathic Medical College and Research Centre Sant Tukaram Nagar Pimpri Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9422301824 |
| Fax |
|
| Email |
manish.arya@dpu.edu.in |
|
|
Source of Monetary or Material Support
|
| Dr D Y Patil Homoeopathic Medical College and Research Centre Sant Tukaram Nagar Pimpri Pune 411018 Maharashtra INDIA |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 Khyati Pundir |
Dr D Y Patil Homoeopathic Medical College and Research Centre |
OPD IPD COMPLEX 1ST FLOOR DEPARTMENT OF HOMOEOPATHIC REPERTORY AND CASE TAKING
Pune
MAHARASHTRA |
09680038050
khyati.pundiri8431@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr D Y Patil Homoeopathic Medical College and Research Centre Institutional Ethics 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 |
Individualized Homoeopathic Medicine |
Dose centesimal scale
Frequency TDS
ROUTE ORAL
DURATION 6 MONTHS |
| Comparator Agent |
Nil |
Not Applicable as single arm study |
|
|
Inclusion Criteria
|
| Age From |
45.00 Day(s) |
| Age To |
55.00 Day(s) |
| Gender |
Female |
| Details |
FSH level more than 40 mIU per ml
Patient presenting with
Vasomotor symptoms like hot flush and night sweats
Psychological symptoms like mood swings poor memory
Urogenital symptoms like vaginal dryness and urine troubles
|
|
| ExclusionCriteria |
| Details |
Patient taking Hormone Replacement Therapy |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in Menopausal complaints |
Baseline fortnightly till end of 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To improve the quality of life of women in menopausal phase by giving homoeopathy medicines |
6 months |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
30/10/2025 |
| 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 is a single arm experimental study to evaluate the effectiveness of individualized homeopathic medicines in management of menopausal complaints in women age group 45 to 55 years and these medicines will be chosen using the Boger Boenninghausens Characteristics Repertory and 50 patients who will meet the inclusion criteria through purposive sampling will be selected and data will be gathered through detailed case taking and lab investigation and Greene Climacteric Scale will be used |