| CTRI Number |
CTRI/2024/05/067677 [Registered on: 20/05/2024] Trial Registered Prospectively |
| Last Modified On: |
18/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
The effectiveness of homeopathic medicines in the cases of menopause during climacteric age. |
|
Scientific Title of Study
|
An Experimental Clinical Study to understand the role of Homoeopathic Medicines in cases of Menopause in climacteric age assessed with the help of MRS 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 Divya Alabhai Jalu |
| Designation |
PG Scholar |
| Affiliation |
Rajkot Homoeopathic medical college |
| Address |
Department of Homoeopathic materia medica, Rajkot Homoeopathic Medical College
Rajkot
GUJARAT
360001
India |
| Phone |
9909487095 |
| Fax |
|
| Email |
dwitika.ahir@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajesh D Sanja |
| Designation |
MD (Hom.), H.O. D. and Professor, Department of Homoeopathic Materia Medica |
| Affiliation |
Rajkot Homoeopathic medical college |
| Address |
Department of Homoeopathic materia medica, Rajkot Homoeopathic medical college.
Rajkot
GUJARAT
360002
India |
| Phone |
9825885350 |
| Fax |
|
| Email |
drrajeshsanja@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajesh D Sanja |
| Designation |
MD (Hom.), H.O. D. and Professor, Department of Homoeopathic Materia Medica |
| Affiliation |
Rajkot Homoeopathic medical college |
| Address |
Department of Homoeopathic materia medica, Rajkot Homoeopathic Medical College.
Rajkot
GUJARAT
360002
India |
| Phone |
9825885350 |
| Fax |
|
| Email |
drrajeshsanja@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rajkot Homoeopathic medical college, Behind jaynath complex, makkam chowk, gondal road, 360002, Rajkot, Gujarat,India. |
|
|
Primary Sponsor
|
| Name |
Dr Divya Alabhai Jalu |
| Address |
Rajkot Homoeopathic medical college, Behind jaynath complex, makkam chowk, gondal road, 360002,rajkot, Gujrat, India. |
| 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 Divya Alabhai Jalu |
Rajkot Homoeopathic Medical College, Sainath Homoeopathic Hospital. |
Department of Homoeopathic materia medica(PG)
Rajkot
GUJARAT |
9909487095
dwitika.ahir@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee for human research(IECHR)-Rajkot Homoeopathic Medical College(RHMC), Rajkot, Parul University, Gujarat. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N00-N99||Diseases of the genitourinary system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualised Homoeopathic medicines |
Selection of medicine :- The Individualised homeopathic medicines will selected after case taking with help of synthesis repertory and knowledge of materia medica.
Potencies :- 30c, 200c, 1M will be used.
Dose :- As per requirement of each case.
Repitition:- As per requirement of each case.
Duration :- 3-6 months.
|
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Female |
| Details |
Only female patients of climecteric age will be considered.
All socio-economical classes will be considered.
Cases with duly consent of patient |
|
| ExclusionCriteria |
| Details |
Complicated cases with advanced, irreversible pathological conditions and
immunocompromised Patients.
Patients who are under the treatment of other system of medicine for any other disease
condition. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To ascertain the effectiveness of homoeopathic medicines in cases of
menopause assessed by Menopausal rating scale(MRS). |
24 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To improve the quality of life of the patients suffering with menopause.
To study the homeopathic medicines for the menopause. |
24 weeks |
|
|
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)
|
30/05/2024 |
| 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
|
The Menopause is transition from reproductive age to non-reproductive age at the end of reproductive life. However it bring many discomfort to woman which impact her physical and mental life. Symptomatology under menopause are hot flushes, perspiration, mood swings, insomnia, joint discomfort, irritability, mental exhaustion etc. Homeopathic medicines has wide scope in improving menopause ailments. It help to relieves the menopause symptoms and help in smoother transition from reproductive age to non-reproductive age. |