| CTRI Number |
CTRI/2025/11/098226 [Registered on: 28/11/2025] Trial Registered Prospectively |
| Last Modified On: |
24/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Homoeopathic treatment of chronic low back pain. |
|
Scientific Title of Study
|
Management of chronic low back pain with individualized homoeopathic medicine in adult population with special emphasis on accessory circumstances: an open label single arm pre and post clinical study |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1330-9055 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Arnab Ranjan Das |
| Designation |
Postgraduate trainee |
| Affiliation |
The Calcutta Homoeopathic Medical College and Hospital |
| Address |
Department of Organon of Medicine, OPD Room no 19, 265, 266, Acharya Prafulla Chandra Road, Kolkata 700009 West Bengal India
Department of Organon of Medicine, OPD Room no 19, 265, 266, Acharya Prafulla Chandra Road, Kolkata 700009, West Bengal, India
Kolkata
WEST BENGAL
700009
India |
| Phone |
9038824006 |
| Fax |
|
| Email |
drarnabranjandas@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Aloke Kumar Ghosh |
| Designation |
Head of The Department of Organon of Medicine |
| Affiliation |
The Calcutta Homoeopathic Medical College and Hospital |
| Address |
Department of Organon of Medicine, OPD Room no 19, 265, 266, Acharya Prafulla Chandra Road, Kolkata 700009, West Bengal, India
Kolkata
WEST BENGAL
700009
India |
| Phone |
9836584268 |
| Fax |
|
| Email |
dralok1974ghosh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr Aloke Kumar Ghosh |
| Designation |
Head of The Department of Organon of Medicine |
| Affiliation |
The Calcutta Homoeopathic Medical College and Hospital |
| Address |
Department of Organon of Medicine, OPD Room no 19, 265, 266, Acharya Prafulla Chandra Road, Kolkata 700009, West Bengal, India
Kolkata
WEST BENGAL
700009
India |
| Phone |
9836584268 |
| Fax |
|
| Email |
dralok1974ghosh@gmail.com |
|
|
Source of Monetary or Material Support
|
| The Calcutta Homoeopathic Medical College and Hospital, 265, 266, Acharya Prafulla Chandra Road, Kolkata 700009, West Bengal, India |
|
|
Primary Sponsor
|
| Name |
Dr Arnab Ranjan Das |
| Address |
265 266 Acharya Prafulla Chandra Road Kolkata 700009 West Bengal |
| 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 Arnab Ranjan Das |
The Calcutta Homoeopathic Medical College and Hospital |
Department of Organon of Medicine, Room number 19 and 17, 265,266, Acharya Prafulla Chandra Road, Kolkata 700009 West Bengal
Kolkata
WEST BENGAL |
09038824006
drarnabranjandas@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of The Calcutta Homoeopathic Medical College and Hospital, 265, 266, Acharya Prafulla Chandra Road, Kolkata 700009, West Bengal |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: M545||Low back pain, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualized Homoeopathic Medicine |
Intervention is planned as administering indicated homoeopathic medicines in centesimal potencies (CH). Each dose will consist of 1 cane sugar globules no. 20 moistened with the indicated medicine (preserved in 90% v/v ethanol), to be taken orally on clean tongue in empty stomach; dosage and repetition depending upon the individual requirement of the cases. Patients will be advised to refrain from handling the globules or from eating, drinking, smoking or brushing teeth within 30 minutes of taking the globules and will be asked to suck the globules rather than simply swallowing those. Single individualized
medicine will be prescribed on each occasion taking into account presenting symptom
totality, clinical history details, constitutional features, miasmatic expressions, repertorization using HOMPATH/RADAR software when required with due consultation of Materia Medica and due consensus among three homoeopaths. All the medicines and sundry items will be procured from a Good Manufacturing Practice. |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients suffering from chronic low back pain (ICD -11 code MG30.02)
2. Participants fulfilling AAPT Diagnostic criteria for Chronic Musculoskeletal Low Back Pain Dimension 1
3. Age between 18 to 60 years
4. Patients with radiological diagnosis indicating different cases of low back pain with mild to moderate degenerative radiological changes.
5. Patient of either sex.
6. Patients, who can read or write or understand English, Bengali, Hindi.
7. Patient given written consent to participate.
|
|
| ExclusionCriteria |
| Details |
1. Patient not willing to participate in study.
2. Patient too sick for consultation.
3. Patients with severe degenerative changes in radiological findings like spinal abnormalities, malignancy, fracture, cauda equina syndrome, infection, ankylosing spondylitis, epidural abscess, congenital abnormalities, etc.
4. Patient with history of spinal surgery or requiring or willing for the same.
5. Patient undergoing Homoeopathic treatment for chronic disease within last 6 weeks.
6. Non-ambulant patient.
7. Obese patient (BMI 30.0 or more)
8. Patient with uncontrolled diabetes, hypertension, cancer, any other systemic illness or vital organ failure.
9. Vulnerable population- unconscious, differently abled, terminally ill, or critically ill patients, institutionalized subjects, mentally incompetent, patients with psychiatric illness.
10. Patients with immunocompromised state.
11. Pregnant and puerperal woman, lactating mother.
12. Patients with habits of tobacco chewing, and or smoking, alcoholism, and or any other forms of substance abuse and or dependence.
13. Simultaneous participation in any other clinical trial.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1.To measure the changes in Oswestry Disability Index (ODI) questionnaire after 3 months of intervention. |
At Baseline and 3rd month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To measure the changes in the pain intensity in Numerical Pain Rating Scale
2.To measure the changes in EQ-5D-5L Questionnaire
3. To assess the role of accessory circumstances.
4. To ascertain and shortlist the most frequently indicated homoeopathic medicines in the treatment of chronic low back pain
|
Baseline, every month upto 3months
Baseline, every month upto 3months
At 3rd month
At 3rd month |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
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)
|
05/12/2025 |
| 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
|
Low back pain is defined as pain and discomfort, localized below the costal
margin and above the inferior gluteal folds, with or without leg pain.[21] Pain that lasts longer
than three months (Merskey 1986) and is restricted to the area bounded by, the L1 vertebrae
above, and the S1 vertebrae below, and the erector spinae muscles laterally is referred to as
Chronic low back pain (CLBP). An estimated 619 million people worldwide were predicted to have low
back pain in 2020. Intervention is planned as administering indicated homoeopathic medicines in centesimal
potencies (CH). Each dose will consist of 1 cane sugar globules no. 20 moistened with the
indicated medicine (preserved in 90% v/v ethanol), to be taken orally on clean tongue in
empty stomach; dosage and repetition depending upon the individual requirement of the
cases. Duration of therapy: 3 months with monthly follow-ups. It is a open label, single arm, interventional study. |