| CTRI Number |
CTRI/2025/10/096473 [Registered on: 27/10/2025] Trial Registered Prospectively |
| Last Modified On: |
23/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Role of Homoeopathic medicine in Low Back Pain |
|
Scientific Title of Study
|
Effectiveness of individualized homoeopathic medicine in centesimal potency for the treatment of pain and disability in lumbosacral radiculopathy - A single arm pre and post interventional 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 Montajul Ali Molla |
| Designation |
Post Graduate Trainee |
| Affiliation |
National Institute of Homoeopathy |
| Address |
OPD no 18, Department of Homoeopathic Materia Medica, National Institute of Homoeopathy, Block GE, Sector 3, Saltlake Kolkata
Kolkata
WEST BENGAL
700106
India |
| Phone |
8617719054 |
| Fax |
|
| Email |
doctormali212@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Chintamani Nayak |
| Designation |
Associate Professor, HOD |
| Affiliation |
National Institute of Homoeopathy |
| Address |
OPD no 18, Department of Homoeopathic Materia Medica, National Institute of Homoeopathy, Block GE, Sector 3, Saltlake Kolkata
Kolkata
WEST BENGAL
700106
India |
| Phone |
9433161854 |
| Fax |
|
| Email |
drcnayak@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Chintamani Nayak |
| Designation |
Associate Professor, HOD |
| Affiliation |
National Institute of Homoeopathy |
| Address |
OPD no 18, Department of Homoeopathic Materia Medica, National Institute of Homoeopathy, Block GE, Sector 3, Saltlake Kolkata
WEST BENGAL
700106
India |
| Phone |
9433161854 |
| Fax |
|
| Email |
drcnayak@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Homoeopathy, block GE, Sector 3, Saltlake, Kolkata, 700106 |
|
|
Primary Sponsor
|
| Name |
National Institute of Homoeopathy |
| Address |
Block GE, Sector 3, Saltlake Kolkata, 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 Montajul Ali Molla |
National Institute of Homoeopathy |
OPD no 18, Department of Homoeopathic Materia Medica, National Institute of Homoeopathy, Block GE, Sector 3, Saltlake Kolkata 700106
Kolkata
WEST BENGAL |
8617719054
doctormali212@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| National Institute of Homoeopathy Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M541||Radiculopathy, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualized Homoeopathic medicine in Centesimal potency for 6 months |
Medicine will be prescribed in
Centesimal potency according to Homoeopathic principles
regarding dose, potency and
repetition. Indicated Homoeopathic medicine will be
administered for a period of 6
months. Total duration of therapy: 6 months for each
individual patient. Data will be recorded at baseline, 3 months and 6 months for each individual patient. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Participants of all gender, religion and socioeconomic status with lumbosacral
radiculopathy
Participants presenting with clinical features and radiological findings of lumbosacral
radiculopathy
X-ray finding of Lumbar/Sacral spondylosis with radiculopathy symptoms
Radiological findings i.e. X-Ray, NCV, CT or MRI reports should be within 2 years
Participants who can understand Bengali, Hindi or English
Participants who are willing to give written consent to participate in the study |
|
| ExclusionCriteria |
| Details |
Cases with congenital lumbar and sacral anomalies (e.g., Sacralization of fifth
lumbar- vertebrae, Spina bifida etc.)
Persons with immunocompromised state and terminal or life threatening illness
Participants shifting from one system of medicine to another system of medicine frequently
Participant undergone lumbar spine surgery
Lumbosacral radiculopathy with bone fracture
Pregnant and Lactating women
Participant with Psychiatric disorder |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Oswestry Low Back Pain Disability Questionnaire score |
At baseline, 3 months and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| MYMOP2 Questionnaire score |
At baseline, 3 months and 6 months |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
07/11/2025 |
| 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 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
|
LUMBOSACRAL RADICULOPATHY ICD 10 DIAGNOSIS CODE- M54.17 Lumbosacral radiculopathy is a condition where a nerve root in the lower back (lumbar and sacral spine) is compressed or irritated, leading to pain, numbness, tingling, or weakness in the lower back and legs. One of the most common causes of this condition is herniation of intervertebral discs, although other 5 etiologies such as spinal stenosis, tumors, inflammation, and degenerative changes (lumbar/sacral spondylosis) can also be implicated. Patients who are suffering from low back pain and registered in OPD and IPD of National Institute of Homoeopathy, Kolkata and fulfilling the criteria of inclusion and exclusion will be taken as sample of this study. Dose and frequency of the medicine will be as per the homoeopathic principles. Individualized homoeopathic medicine will be prescribed in centesimal potency. Pain and disability will be assessed by Oswestry Low Back pain (ODI) and MYMOP2 scale at baseline, 3 months and 6 months, to see the effectiveness of individualized homoeopathic medicine in Lumbosacral Radiculopathy. |