| CTRI Number |
CTRI/2025/03/081623 [Registered on: 04/03/2025] Trial Registered Prospectively |
| Last Modified On: |
03/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy
Other (Specify) [Therapeutic] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effectiveness of homoeopathic medicine in treatment of lumbar spondylosis in postmenopausal women |
|
Scientific Title of Study
|
Effectiveness of individualized homoeopathic medicine in treatment of pain & stiffness of lumbar spondylosis in post menopausal women an open label pre and post interventional 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 Mousumi Roy |
| Designation |
Post graduate trainee |
| Affiliation |
National Institute of Homoeopathy |
| Address |
National Institute of Homoeopathy GE Block Salt Lake Sector 3 Kolkata700106 West Bengal Department of Homoeopathic Materia medica OPD Room no 18
Kolkata
WEST BENGAL
700106
India |
| Phone |
9340541886 |
| Fax |
|
| Email |
drmousumir@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mousumi Roy |
| Designation |
Post graduate trainee |
| Affiliation |
National Institute of Homoeopathy |
| Address |
National Institute of Homoeopathy GE Block Saltlake Sector 3 Kolkata 700106 West Bengal Department of Materia medica opd room no 18
Kolkata
WEST BENGAL
700106
India |
| Phone |
9340541886 |
| Fax |
|
| Email |
drmousumir@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Usha Ghelani Uchat |
| Designation |
Professor & HOD of Materia medica department |
| Affiliation |
National Institute of Homoeopathy |
| Address |
National Institute of Homoeopathy GE Block Saltlake Sector 3 Kolkata 700106 West Bengal department of Homoeopathic Materia medica opd room no 18
Kolkata
WEST BENGAL
700106
India |
| Phone |
9830966265 |
| Fax |
|
| Email |
ushauchat@gmail.com |
|
|
Source of Monetary or Material Support
|
| Govt medical college Natioal Institute of Homoeopathy GE Block Saltlake Sector 3 Kolkata 700106 West Bengal India |
|
|
Primary Sponsor
|
| Name |
Self Dr Mousumi Roy |
| Address |
National Institute of Homeopathy
GE Block Saltlake sector 3 Kolkata 700106 West Bengal Department of Materiamedica |
| Type of Sponsor |
Other [Self Dr Mousumi Roy] |
|
|
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 Mousumi Roy |
National Institute of Homoeopathy |
National Institute of Homoeopathy GE Block Saltlake sector 3 Kolkata 700106 West Bengal Department of Materia Medica OPD Room no 18
Kolkata
WEST BENGAL |
9340541886
drmousumir@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical committee of National Institute of Homoeopathy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M45-M49||Spondylopathies, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualized homoeopathic medicine |
All patients will be given medicines based on homoeopathic principles along indicated medicines were used in Centesimal or LMscale, administeredorally. Repetition of the medicines was done depending upon the severity of the symptoms and susceptibility of thepatients.Follow-up was done at an interval of approximately 1 month or as per requirement of the case.
Duration of therapy: 6 months
|
| Comparator Agent |
Nil |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
1 Patient presenting with clinical features and radiological findings of lumbar spondylosis 2 Female gender with both acute and chronic complains 3 all socio economical status 4 patient who are willing to give informed consent to participate in the study |
|
| ExclusionCriteria |
| Details |
1Case with congenital lumbar annomalies eg spina bifida 2Patient unwilling to give consent for taking part in the study and regular follow ups 3Patient with terminal or life threatening illness 4 Patient shifting from one system of medicine to another system of medicine frequently 5 Patient undergone lumbar spine surgery |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To measure difference in mean Oswestry low back pain disability quistionnarire score. |
baseline and after 6 months of treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| not present |
|
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
14/03/2025 |
| 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 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
|
Research Question whether individualized homoeopathic medicine can produce change in pain and stiffness in lumbar spondylosis among the post menopausal women Null hypothesis there is no significant difference in mean Oswestry Low Back Pain Disability Questionnaire score before and after giving Homoeopathic Individualized medicine for 6 months selected by individualization in case of lumbar spondylosis among post menopausal women Alternative Hypothesis there is significant difference in mean Oswestry Low Back Pain Disability Questionaarie score before and after giving Homoeopathic Individualized medicine for 6 months selected by individualization in cases of lumbar spondylosis among post menopausal women Aim to evaluate the effectiveness of Homoeopathic Individualized medicine in the treatment of pain and stiffness of lumbar spondylosis among post menopausal women Objectives to ascertain the change in Oswestry Low Back Pain Disability Questionnarire score before and after medical intervention via individualized medicine |