| CTRI Number |
CTRI/2023/03/050202 [Registered on: 01/03/2023] Trial Registered Prospectively |
| Last Modified On: |
02/03/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Homoeopathic treatment of neck pain |
|
Scientific Title of Study
|
Repertorial approach of pain management in cervical radiculopathy in adults by using individualized homoeopathic medicines: Double-blind, randomized, placebo-controlled trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1288-7475 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Swarup Biswas |
| Designation |
Postgraduate Trainee |
| Affiliation |
D N De Homoeopathic Medical College and Hospital |
| Address |
Dept. of Repertory, 12, Gobinda Khatick Road, Tangra
Kolkata
WEST BENGAL
700046
India |
| Phone |
6290295699 |
| Fax |
|
| Email |
biswasswarup786@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rajat Kumar Pal |
| Designation |
Professor and Head |
| Affiliation |
D N De Homoeopathic Medical College and Hospital |
| Address |
Dept. of Repertory, 12, Gobinda Khatick Road, Tangra
Kolkata
WEST BENGAL
700046
India |
| Phone |
9433130996 |
| Fax |
|
| Email |
drrajatkumarpal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rajat Kumar Pal |
| Designation |
Professor and Head |
| Affiliation |
D N De Homoeopathic Medical College and Hospital |
| Address |
Dept. of Repertory, 12, Gobinda Khatick Road, Tangra
Kolkata
WEST BENGAL
700046
India |
| Phone |
9433130996 |
| Fax |
|
| Email |
drrajatkumarpal@gmail.com |
|
|
Source of Monetary or Material Support
|
| D N De Homoeopathic Medical College and Hospital, 12, Gobinda Khatick Road, Tangra, Kolkata 700046 |
|
|
Primary Sponsor
|
| Name |
D N De Homoeopathic Medical College and Hospital |
| Address |
12, Gobinda Khatick Road, Tangra, 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 |
| Swarup Biswas |
D N De Homoeopathic Medical College and Hospital |
OPD no. PG3, Research and Medicine, Dept.
of Repertory, 12,
Gobinda Khatick Road,
Tangra
Kolkata
WEST BENGAL
Kolkata
WEST BENGAL |
6290295699
biswasswarup786@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics 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 |
| Comparator Agent |
Identical-looking placebos plus concomitant care |
This group will receive placebos, identical in appearance with the verum. Each dose will consist of 4 cane sugar globules no. 40,
moistened with 90% v/v ethanol, to be taken orally on clean tongue with empty stomach; dosage and repetition will be decided depending upon the individual requirement of the cases. All sundry items will be procured from a Good
Manufacturing Practice (GMP)
certified firm. All the enrolled participants will receive advice on concomitant care, i.e., ice cube massage over the painful part of neck, or fomentations, isometric neck exercises, Alexander technique, upper trap stretch, levator scapulae stretch, deep anterior neck flexor stretch, suboccipital stretch, rhomboid and middle trap stretch, use of neck braces, avoiding excess bending of neck and lifting heavy weight on head, neck or shoulder, etc. Duration of therapy: 2 months |
| Intervention |
Individualized homeopathic
medicines in centesimal
potencies plus concomitant care |
Intervention is planned as
administering the indicated
homeopathic medicines in
centesimal potencies (CH).
Each dose will consist of 4 cane sugar globules no. 40
moistened with the indicated
medicine (preserved in 90% v/v
ethanol), to be taken orally on clean tongue with 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. All the medicines and sundry items will be procured from a Good Manufacturing Practice (GMP) certified firm. All the enrolled participants will receive advice on concomitant care, i.e., ice cube massage over the painful part of neck, or fomentations, isometric neck exercises, Alexander technique, upper trap stretch, levator scapulae stretch, deep anterior neck flexor stretch, suboccipital stretch, rhomboid and middle trap stretch, use of neck braces, avoiding excess bending of neck and lifting heavy weight on head, neck or shoulder, etc. Duration of therapy: 2 months. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients suffering from cervical radiculopathy (ICD10 CM code M54.12) for 3 months or more who shows Spurling’s test positive and Bakody’s sign or positive shoulder abduction test.
2. Age between 18 and 65 years
3. Participants of either sex or transgender
4. Literate participants, ability to read and write in English, Bengali and/or Hindi. Illiterate participants will be interviewed by the investigators maintaining adequate privacy to fill up the scales or questionnaires.
5. Providing with written informed consent voluntarily |
|
| ExclusionCriteria |
| Details |
1. Cases with complications such as incomplete neurological recoveries, disc prolapse, disc herniation.
2. Patients with the history of taking spinal steroid injection within 6 months.
3. Patients on regular NSAIDS therapy.
4. Patients with uncontrolled diabetes mellitus, uncontrolled hypertension, or uncontrolled cardiovascular disease.
5. Vulnerable population - unconscious, non-ambulatory, too sick for consultation, differently abled, terminally ill or critically ill patients, institutionalized subjects, mentally incompetent people.
6. Diagnosed cases of unstable mental or psychiatric illness or other uncontrolled or life-threatening illness affecting quality of life or any organ failure.
7. Pregnant and puerperal women, lactating mothers.
8. Patients with a habit of tobacco chewing and/or smoking, alcoholism and/or any other form(s) of substance abuse and/or dependence.
9. Self-reported immune-compromised states.
10. Already undergoing homoeopathic treatment for chronic disease within last 6 months.
11. Simultaneous participation in any other clinical trials |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
0-10 numeric rating scale measuring intensity of
pain |
Baseline, month 1, month 2 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| McGill Pain Questionnaire Short Form |
Baseline, month 1, month 2 |
| Neck disability index |
Baseline, month 1, month 2 |
|
|
Target Sample Size
|
Total Sample Size="117"
Sample Size from India="117"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
03/04/2023 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
None yet; to be published later |
|
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-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- 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 [biswasswarup786@gmail.com].
- For how long will this data be available start date provided 01-01-2026 and end date provided 31-12-2031?
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
|
Cervical radiculopathy is a clinical condition resulting from compression of cervical nerve roots. The annual incidence is 107.3 per 100,000 for men and 63.5 per 100,000 for women. The incidence seems to peak in the fourth and fifth decades in life. Risk factors include lifting heaving objects, frequent diving from a board, driving equipment that vibrates, and trauma. Up to 30% of patients report the onset of pain in neck and arms when sitting, walking, or standing. Though the use of homoeopathic medicines is extensive globally to treat the condition, research evidence in favor of homeopathy is not well marked. So, we intend to undertake the trial to evaluate the efficacy and safety of homoeopathic medicines in the treatment of cervical radiculopathy. Though the use of homoeopathic medicines is prevalent globally to treat the condition, rigorous research evidence in support of homoeopathy in cervical radiculopathy has remained compromised. Under such circumstances, we intend to undertake this research project to evaluate the efficacy and safety of homeopathic medicines in the treatment of cervical radiculopathy in adults. A double-blind, randomized (2:1), placebo-controlled trial will be conducted on 117 adult participants with cervical radiculopathy at the outpatient department of D. N. De Homoeopathic Medical College and Hospital. Primary outcome measure is Numerical pain rating scale (NPRS), to be measured every month, up to 2 months. Secondary outcome measures are McGill Pain Questionnaire short-form (McGillPQ-SF) and Neck Disability Index (NDI), to be measured every month, up to 2 months. Comparative analysis will be carried out to detect group differences. |