| CTRI Number |
CTRI/2024/03/064927 [Registered on: 28/03/2024] Trial Registered Prospectively |
| Last Modified On: |
27/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A comparative Study to assess the usefulness of Homoeopathic medicines in the management of postmenopausal syndrome |
|
Scientific Title of Study
|
A Comparative Study To Assess The Usefulness Of Homoeopathic Medicine Selected From Mintons Uterine Therapeutics Repertory And Boenninghausens Characteristics And Repertory In The Management Of Post Menopausal Syndrome A Randomized 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 Shahana |
| Designation |
PG Scholar |
| Affiliation |
Dr M P K Homoeopathic Medical College Hospital And Research Centre |
| Address |
Department Of Repertory Dr M P K Homoeopathic Medical College Hospital And Research Centre A Constituent College Of Homoeopathy University Saipura Sanganer Jaipur Rajasthan
Jaipur
RAJASTHAN
302029
India |
| Phone |
7771944147 |
| Fax |
|
| Email |
shahanashah2@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sameer Bidwalkar |
| Designation |
Professor |
| Affiliation |
Dr M P K Homoeopathic Medical College Hospital And Research Centre |
| Address |
Department Of Repertory Dr M P K Homoeopathic Medical College Hospital And Research Centre A Constituent College Of Homoeopathy University Saipura Sanganer Jaipur Rajasthan
Jaipur
RAJASTHAN
302029
India |
| Phone |
9414078227 |
| Fax |
|
| Email |
bidwalkars@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shahana |
| Designation |
PG Scholar |
| Affiliation |
Dr M P K Homoeopathic Medical College Hospital And Research Centre |
| Address |
Department Of Repertory Dr M P K Homoeopathic Medical College Hospital And Research Centre A Constituent College Of Homoeopathy University Saipura Sanganer Jaipur Rajasthan
Jaipur
RAJASTHAN
302029
India |
| Phone |
7771944147 |
| Fax |
|
| Email |
shahanashah2@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department Of Repertory Dr Girendra Pal Homoeopathic Hospital And Research Centre Collegiate Hospital Of Dr M P K Homoeopathic Medical College Hospital And Research Centre A Constituent College Of Homoeopathy University Saipura, Sanganer, Jaipur, Rajasthan, 302029 |
|
|
Primary Sponsor
|
| Name |
Dr M P K Homoeopathic Medical College Hospital And Research Centre |
| Address |
10 11 12 Ward No 36 Saipura Sanganer Jaipur Rajasthan 302029 |
| 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 Shahana |
Dr Girendra Pal Homoeopathic Hospital and Research Centre |
Department Of Repertory OPD Room No 3 Dr M P K Homoeopathic Medical College Hospital And Research Centre A Constituent College Of Homoeopathy University 10 11 12 Ward No 36 Saipura Sanganer Jaipur Rajasthan 302029
Jaipur
RAJASTHAN |
7771944147
shahanashah2@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Homoeopathy University Jaipur |
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 |
Individualised Homoeopathic medicine selected from Boger Boenninghausens Characteristics and Repertory |
Homoeopathic Medicine shall be given orally in any potency 6c, 30c, 200c, 1M, 10M, 50M and CM as per the case and Hahnemannian guidelines of Organon of Medicine in the form of globules of 40 numbers, Dose and Repetition as per need of the case reassessment at the end of 3 month |
| Intervention |
Individualised Homoeopathic medicine selected from Mintons Uterine Therapeutics and Repertory |
Homoeopathic Medicine shall be given orally in any potency 6c, 30c, 200c, 1M, 10M, 50M and CM as per the case and Hahnemannian guidelines of Organon of Medicine in the form of globules of 40 numbers, Dose and Repetition as per need of the case reassessment at the end of 3 month |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Female |
| Details |
Women of age group above 40 years
Women who had approached to menopause menses have not appeared for minimum last 12 months irrespective of their occupation and socio-economic background
Women who had serum FSH value more than 40mlU/mL
Women who are willing to give consent
|
|
| ExclusionCriteria |
| Details |
The cases which require emergency care or rescue treatment
Women who had serum FSH value less than 40mlU/mL
Women with surgical menopause removal of uterus with ovaries
Women suffering from any systemic disease like malignancy hyperthyroidism etc
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| According to the scores obtained (pre and post treatment and post post treatment) from the Menopausal Rating Scale (MRS) |
Pre score will be taken at baseline of treatment and post score will assessed at the end of 12 weeks using Menopausal Rating Scale |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The individualised homeopoathic medicine selected with the aid of Mintons uterine therapeutics repertory or Boenninghausens characteristics and repertory by C M Boger will be effective in managing the cases of postmenopausal syndrome
It is expected that Homoeopathic medicine will improve the frequency and intensity of postmenopausal syndrome and improve quality of life of patient |
12 months |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
10/04/2024 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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- To compare the usefulness of Mintons uterine therapeutics repertory and Boenninghausens characteristics & repertory by C M Boger in the management of postmenopausal syndrome. OBJECTIVE- To assess the effectiveness of Homoeopathic medicine selected from Mintons uterine therapeutics repertory in the management of postmenopausal syndrome through evaluation of pre and post score of menopausal rating scale To assess the effectiveness of Homoeopathic medicine selected from Boenninghausens characteristics & repertory by C M Boger in the management of postmenopausal syndrome through evaluation of pre and post score of menopausal rating scale To compare which repertory is most effective in the management of postmenopausal syndrome through difference in post scores of menopausal rating scale of Mintons uterine therapeutics repertory and Boenninghausens characteristics & repertory by C M Boger
|