| CTRI Number |
CTRI/2024/05/067313 [Registered on: 14/05/2024] Trial Registered Prospectively |
| Last Modified On: |
13/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Role of Homoeopathy in Lumbar Spondylosis |
|
Scientific Title of Study
|
A Prospective Randomised Two Arm Parallel Clinical Study to Compare the Results of Polarity Analysis method and Conventional Homoeopathic method in the treatment of Lumbar Spondylosis |
| 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 Dolly M |
| Designation |
Junior Resident |
| Affiliation |
Nehru Homoeopathic Medical College and Hospital |
| Address |
Department of Practice of Medicine,Nehru Homoeopathic Medical College and Hospital,B-Block, Defence colony,New Delhi
South
DELHI
110024
India |
| Phone |
7904258825 |
| Fax |
|
| Email |
anumohan14051997@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rakesh Thakkar |
| Designation |
HOD( Practice of Medicine ) |
| Affiliation |
Nehru Homoeopathic Medical College and Hospital |
| Address |
Department of Practice of Medicine,Nehru Homoeopathic Medical College and Hospital,B-Block,Defence colony,New Delhi
South
DELHI
110024
India |
| Phone |
8851006347 |
| Fax |
|
| Email |
rakeshthakkar14@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dolly M |
| Designation |
Junior Resident |
| Affiliation |
Nehru Homoeopathic Medical College and Hospital |
| Address |
Department of Practice of Medicine,Nehru Homoeopathic Medical College and Hospital, B-Block,Defence colony,New Delhi
South
DELHI
110024
India |
| Phone |
7904258825 |
| Fax |
|
| Email |
anumohan14051997@gmail.com |
|
|
Source of Monetary or Material Support
|
| Nehru Homoeopathic Medical College and Hospital,B-Block, Defence colony,New Delhi-110024 |
|
|
Primary Sponsor
|
| Name |
Nehru Homoeopathic Medical College and Hospital |
| Address |
B-Block,Defence colony,New Delhi-110024 |
| 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 Dolly M |
Nehru Homoeopathic Medical College and Hospital |
OPD-4,Osteoarthritis Project,Nehru Homoeopathic Medical College and Hospital, B-Block, Defence colony, New Delhi-110024
South
DELHI |
7904258825
anumohan14051997@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institutional Ethics committee -NHMC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M478||Other spondylosis, (2) ICD-10 Condition: M472||Other spondylosis with radiculopathy, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Administration of individualized Homeopathic Medicine chosen by Conventional homoeopathic method |
After obtaining consent and screening using specified selection criteria, 30 patients will be included in this group based on block randomization chart. Detailed case taking will be done using case taking proforma. Based on available symptoms in the case, repertorial totality will be erected. Then appropriate repertory will be used for medicine selection. Mode of administration will be oral. Centisimal scale of potency will be used. One Dose consists of 4 globules. Potency and repetition of medicine depends upon severity of symptoms and susceptibility of patient. Outcome parameters will be assessed at baseline and after 3 months. |
| Intervention |
Administration of individualized homeopathic medicine chosen by Polarity analysis method |
After obtaining consent and screening using specified selection criteria, 30 patients will be included in this group based on block randomization chart. Detailed case taking will be done using case taking proforma and Polarity Analysis questionnaire. Medicine will be chosen based on analysis done in Polarity analysis software. Mode of administration will be oral. Centesimal scale of potency will be used. One Dose consists of 4 globules. Potency and repetition of medicine depends upon severity of symptoms and susceptibility of patient. Outcome parameters will be assessed at baseline and after 3 months. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients presenting with clinical features of lumbar spondylosis with or without radiculopathy
2. Diagnosis confirmed by X-Ray of lumbar spine (AP and Lateral view) showing changes of lumbar spondylosis
3. Patients giving written consent to participate in the study |
|
| ExclusionCriteria |
| Details |
1. Patients with severe disability and who needs surgical intervention.
2. Fractures.
3. Previous back surgery.
4. Diagnosed cases of unstable mental or psychiatric illness or other uncontrolled or life- threatening illness or any organ failure.
5. Pregnancy and lactation.
6. Substance abuse and/or dependence.
7.Self-reported immune-compromised state.
8. Unwilling to participate in the study.
9. Simultaneous participation in any other trial. |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Roland-Morris disability questionnaire.
2.Numerical pain rating scale for back pain |
At baseline and after 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 |
|
Date of First Enrollment (India)
|
25/05/2024 |
| 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 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 Prospective Randomised Two Arm Parallel Clinical Study to Compare the Results of Polarity Analysis method and Conventional homoeopathic method in the treatment of lumbar spondylosis. 60 patients suffering from lumbar spondylosis will be randomized into 2 groups consisting of 30 in each group. Study will be of 1 year duration. Improvement in back pain and disability will be assessed using Roland-Morris disability questionnaire and Numerical pain rating scale for back pain.RESEARCH QUESTION: Is there any significant difference between the two comparable groups i.e.,Results obtained by Polarity analysis method and conventional homoeopathic method in the treatment of lumbar spondylosis? Null hypothesis- There will be no significant difference between the two comparable groups i.e.,Results obtained by Polarity analysis method and conventional homoeopathic method in the treatment of lumbar spondylosis Alternative hypothesis- There will be significant difference between the two comparable groups i.e.,Results obtained by Polarity analysis method and conventional homoeopathic method in the treatment of lumbar spondylosis
AIM To Compare the Results of Polarity Analysis method and Conventional homoeopathic method in the treatment of lumbar spondylosis
OBJECTIVES 1. To assess the effect of individualized homoeopathic medicines in the treatment of lumbar spondylosis and to find out most frequently indicated medicines in lumbar spondylosis 2. To assess and compare the initial and final NUMERICAL PAIN RATING SCALE score and ROLAND-MORRIS DISABILITY QUESTIONNAIRE score in patients who receive individualized Homeopathic Medicine by Polarity Analysis method and Conventional homoeopathic method in the treatment of lumbar spondylosis. 3. To find out most frequently indicated polar symptoms in patients of lumbar spondylosis.
|