| CTRI Number |
CTRI/2023/07/055470 [Registered on: 21/07/2023] Trial Registered Prospectively |
| Last Modified On: |
20/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effectiveness of homoeopathic medicines in the management of Lumbar Spondylosis |
|
Scientific Title of Study
|
Effectiveness of Homoeopathic medicines in the management of pain and disability of lumbar spondylosis selected using Kent’s Repertory- an open observational prospective 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 |
G R Divya Jyoti Anand |
| Designation |
Post Graduate Trainee |
| Affiliation |
National Institute of Homoeopathy |
| Address |
National Institute of Homoeopathy,Department of CaseTaking and Repertory, GE-Block,Sector III,Salt Lake, Kolkata- 700106
North Twentyfour Parganas
WEST BENGAL
700106
India |
| Phone |
8584014456 |
| Fax |
|
| Email |
djyoti02@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Binod Kumar Bhagat |
| Designation |
Professor |
| Affiliation |
National Institute of Homoeopathy |
| Address |
National Institute of Homoeopathy,Department of CaseTaking and Repertory, GE- Block, Sector III, Salt Lake, Kolkata- 700106
North Twentyfour Parganas
WEST BENGAL
700106
India |
| Phone |
8210003741 |
| Fax |
|
| Email |
dr.binodkbhagat@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Binod Kumar Bhagat |
| Designation |
Professor |
| Affiliation |
National Institute of Homoeopathy |
| Address |
National Institute of Homoeopathy,Department of CaseTaking and Repertory, GE-Block, SECTOR III, Salt Lake, Kolkata-700106
North Twentyfour Parganas
WEST BENGAL
700106
India |
| Phone |
8210003741 |
| Fax |
|
| Email |
dr.binodkbhagat@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Homoeopathy,GE Block, Sector III, Salt Lake, Kolkata, West Bengal,700106 |
|
|
Primary Sponsor
|
| Name |
NATIONAL INSTITUTE OF HOMOEOPATHY |
| Address |
NATIONAL INSTITUTE OF HOMOEOPATHY, DEPARTMENT OF CASE TAKING AND REPERTORY, GE-BLOCK, SECTOR III, SALT LAKE, KOLKATA, WEST BENGAL 700106 |
| Type of Sponsor |
Government 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 G R Divya Jyoti Anand |
National Institute of Homoeopathy, Kolkata |
National Institute of Homoeopathy,OPD 10,Department of CaseTaking and Repertory, GE Block, Sector III, Salt Lake,Kolkata, West Bengal, 700106
North Twentyfour Parganas
WEST BENGAL |
8584014456
djyoti02@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| National Institute of Homoeopathy, GE Block, Sector III, Salt Lake, Kolkata-700106, Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M47||Spondylosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Homoeopathic medicine after repertorization done using Repertory of the Homoeopathic Materia Medica by J.T.Kent |
Patients qualifying to inclusion criteria will be included in the study.
Proper case taking of all enrolled patients will be done in standardized case taking proforma which is being used in National Institute of Homoeopathy.
The score of the patients using Oswestry low back pain disability questionnaire will be recorded at baseline, at the end of 3rd and 6th month.
Homoeopathic medicines will be prescribed to all patients after analysis and evaluation of symptoms and proper repertorization using Kent’s Repertory. Indicated homoeopathic remedy will be administered as decided appropriate to the case or condition in appropriate potency and doses. Medicines will be given orally.Each case will be followed up at regular interval as per requirement. Each patient will be studied for 6 months after enrollment in study. Outcome assessment of the patients will be carried out after 6 months of homoeopathic medication based on Oswestry low back pain disability questionnaire recorded at baseline and at the end of 6 months. |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects of age group 30 years to 70 years.
2. Patients presenting with clinical features and radiological findings of lumbar spondylosis.
3. Patients of all genders.
4. Patients willing to give informed consent to participate in the study. |
|
| ExclusionCriteria |
| Details |
1. Cases with congenital lumbar anomalies ( eg, Sacralization of fifth lumbar vertebrae, Spina bifida etc)
2. Patients unwilling to give consent for taking part in the study and regular follow ups.
3. Pregnant and lactating women.
4. Persons with terminal or life threatening illness. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Oswestry Low Back Pain Disability Questionnaire |
At baseline & at the end of 6th month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not applicable |
Not applicable |
|
|
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)
|
31/07/2023 |
| 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
|
Lumbar spondylosis is a degenerative disorder of the lumbar spine characterized clinically by an insidious onset of pain and stiffness and radiologically by osteophyte formation. This is one of the commonest cause of backache. Incidence of lumbar spondylosis is more in the age group 30- 50 years. According to 2022 ICD-10-CM codes the diagnostic code M47.816 is used for spondylosis, without myelopathy or radiculopathy, lumbar region. Oswestry low back pain disability questionnaire score is one of the principal condition specific outcome measures used in the management of spinal disorders. Kent’s Repertory contains a lot of rubrics related to lumbar spondylosis. Conducting a prospective clinical study using general Repertory like Kent’s Repertory will help in verifying the homoeopathic principles and enriching the study of our Materia Medica. |