| CTRI Number |
CTRI/2025/09/093971 [Registered on: 01/09/2025] Trial Registered Prospectively |
| Last Modified On: |
29/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Homeopathic treatment for chronic low back pain in adults |
|
Scientific Title of Study
|
An exploratory, open-label, randomized, controlled, pilot trial comparing the effects of individualized homoeopathic medicines in LM potencies with centesimal potencies in managing chronic low back pain in adults |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1327-4111 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Deepsikha Chakrabarty |
| Designation |
Postgraduate Trainee |
| Affiliation |
D N De Homoeopathic Medical College and Hospital |
| Address |
Dept of Organon of Medicine and Homoeopathic Philosophy, OPD room no. PG1, 12,Gobinda Khatick Road
Kolkata
WEST BENGAL
700046
India |
| Phone |
8250157886 |
| Fax |
|
| Email |
deepsikha.9201@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Deepsikha Chakrabarty |
| Designation |
Postgraduate Trainee |
| Affiliation |
D N De Homoeopathic Medical College and Hospital |
| Address |
Dept of Organon of Medicine and Homoeopathic Philosophy, OPD room no. PG1, 12,Gobinda Khatick Road
Kolkata
WEST BENGAL
700046
India |
| Phone |
8250157886 |
| Fax |
|
| Email |
deepsikha.9201@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Subhasish Ganguly |
| Designation |
Professor, HOD and Principal-in-charge |
| Affiliation |
D N De Homoeopathic Medical College and Hospital |
| Address |
Dept. of Organon of Medicine And Homoeopathic Philosophy,
OPD No, 11 and PG1,
12,Gobinda Khatick Road
Kolkata
WEST BENGAL
700046
India |
| Phone |
9007263548 |
| Fax |
|
| Email |
dr.subhasish67@gmail.com |
|
|
Source of Monetary or Material Support
|
| D N De Homoeopathic Medical College and Hospital, Govt. of West Bengal, 12, Gobinda Khatick Road, Kolkata 700046, West Bengal |
|
|
Primary Sponsor
|
| Name |
D N De Homoeopathic Medical College and Hospital |
| Address |
12, Gobinda Khatick Road, Kolkata 700046, West Bengal |
| 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 Deepsikha Chakrabarty |
D N De Homoeopathic Medical College and Hospital |
Dept. of Organon of Medicine,
OPD No, 11 and PG 1,
12, Gobinda Khatick Road
Kolkata
WEST BENGAL |
8250157886
deepsikha.9201@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of D N De Homoeopathic Medical College and Hospital |
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 |
| Comparator Agent |
Individualized homoeopathic medicines in centesimal potencies plus concomitant care |
This arm will receive individualized homoeopathic medicines (IHMs) in centesimal potencies(CH). Each dose will consist of 3-4 globules (no. 40) of cane sugar, moistened with the indicated medicine (preserved in 90% v/v ethanol) to be taken orally on clean tongue with an 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. On each case single individualized medicine will be prescribed based upon totality of symptoms, constitutional features, clinical history details, miasmatic expressions, repertorization using software HOMPATH/RADAR, when required with due consultation of Materia Medica and due consensus among three homoeopaths. Every medication and other items purchased from a company that has earned Good Manufacturing Practice (GMP) certification.
Concomitant Care: All the enrolled patients will receive advice on general management which includes posture maintenance, lumbo-sacral strengthening exercise, McKenzie exercises. Dose and frequency: Individualized or personalized, as per need of the cases. Duration of therapy: 3 months. Route of administration: Per oral |
| Intervention |
Individualized homoeopathic medicines in LM potencies plus concomitant care |
The enrolled patients of chronic low back pain will be treated with individual homoeopathic medicines (IHMs) selected in LM potencies. The medicine is administered in 120ml bottle of aqua dist. with one 10 no globule mixed it in with few drops of rectified spirit. Each dose is administered after giving 10 strokes mixing in a half- glass of water (containing 120ml) and taking one tea-spoon from it in empty stomach; dosage and repetition depending upon the individual recruitment of the cases. Patients will be advised to refrain from handling the bottle or from eating, drinking, smoking or brushing teeth within 30 minutes of taking the medicine. On each case, single medicine based upon individualization will be prescribed based upon totality of symptoms, clinical history details, constitutional features, miasmatic expression, repertorization using software HOMPATH/RADAR when required with due consultation of Materia Medica and due consensus among three homoeopaths. Every medication and other items purchased from a company that has earned Good Manufacturing Practice (GMP) certification.
Concomitant Care: All the enrolled patients will receive advice on general management which includes posture maintenance, lumbo-sacral strengthening
exercise, McKenzie exercises.
Dose and frequency: Individualized or personalized, as per need of the cases. Duration of therapy: 3 months. Route of administration: Per oral |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Age group 18-65 years
2. Participants of either sex or transgender
3. Patients suffering from low back pain for
3months or more
4. Patients suffering from moderate and severe
pain; using Numeric Rating Scale (NRS).Patients
will be categorized into mild (NRS 0-3),
moderate (NRS 4-7) or severe (NRS 8-10).
5. Patients with radiological diagnosis indicating
different causes of low back pain, mild to
moderate degenerative radiological changes.
|
|
| ExclusionCriteria |
| Details |
1. Unwilling to take part and not providing with written informed consent of participation.
2. Patients who have undergone spine surgery within 6 months.
3. Patients with severe degenerative changes in radiological findings like congenital abnormalities, infection, tumour, malignancy.
4. Patients having severe and extremely severe DASS-21 score (severe depression-11-13, anxiety-8-9, stress-13-16 and extremely severe depression-14+, anxiety -10+, stress-17+)
5. Immuno-compromised state, AIDS, hepatitis et
6. Uncontrolled diabetes, hypertension, cancer or any other systemic illness or any vital organ failure.
7. Vulnerable population: unconscious,non-ambulatory,too sick for consultation, differently abled, terminally or critically ill patients, mentally incompetent people.
8. Tobacco chewing and/ or smoking, alcoholism and/ or any form(s) of substance abuse and/ or dependance (TAPS tool)
9. Pregnancy, puerperal women and lactating mother.
10. Undergoing homoeopathic treatment for any chronic disease within last 6months.
11. Simultaneous participation in any other clinical trial.
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To explore feasibility of a definitive future trial |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Oswestry Disability Index (ODI) |
Baseline, every month, up to 3 months |
| Depression, Anxiety, Stress Scale Short Form (DASS-21) |
Baseline, every month, up to 3 months |
|
|
Target Sample Size
|
Total Sample Size="102"
Sample Size from India="102"
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)
|
15/09/2025 |
| 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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [deepsikha.9201@gmail.com].
- For how long will this data be available start date provided 01-01-2028 and end date provided 31-12-2032?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Chronic low back pain is defined by the persistence of pain beyond 12 weeks of symptoms, contributing to anxiety, depression, disability, sleep disturbances, poor quality of life. Low back pain is one of the most prevalent musculoskeletal disorders affecting people of all ages and is a major cause of disease burden globally. After upper respiratory tract illness, low back pain ranks as the second most common reason for absenteeism from work. Over 5 million people are incapacitated by low back pain, and about 25 million people lose work as a result. Smoking, heredity and recurrent trauma are recognized risk factors for progressive lumbar degenerative changes. Persistent pain and emotional anguish are also associated with chronic musculoskeletal diseases, and they are frequently the main complaints of patients. Compared to people without LBP, those who have it are more prone to experience anxiety or depression. This association has been seen in a number of prevalence studies, such as recent research of the general population in Qatar, which found that those with LBP had greater rates of anxiety disorders (9.5% vs. 6.2%) and depression ( 13.7% vs. 8.5%) than people without LBP. High - quality guidelines state that exercise, manual therapy acupuncture, paracetamol, or NSAIDs may be used to manage patients with chronic low back pain. Statistical pooling of 4 RCTs demonstrated that homoeopathic medications in centesimal potencies considerably reduced chronic low back pain, significantly better than placebo. In case of LM potency, no such trials have been conducted. So, centesimal potency is regarded as the control group in this experiment due to the success of prior investigations. An open-label, randomized (1:1), centesimal controlled trial will be conducted on 102 adults who are suffering from chronic low back pain at the outpatient’s department of D. N. De Homoeopathic Medical College and Hospital. This study will explore the feasibility of a definitive future trial and assessment will be done by Oswestry Disability Index (ODI) and Depression, Anxiety, Stress Scale Short Form (DASS -21) -both are secondary outcomes; at baseline, every month, up to 3 months. Comparative analysis will be carried out to detect group differences. |