| CTRI Number |
CTRI/2023/04/051991 [Registered on: 26/04/2023] Trial Registered Prospectively |
| Last Modified On: |
26/04/2023 |
| 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 medicines for neck pain |
|
Scientific Title of Study
|
A double-blind, randomized, placebo-controlled trial of individualized homoeopathic medicines as adjunctive to concomitant care in managing chronic neck pain in adolescents and adults |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1290-8046 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ritika Bose |
| Designation |
Postgraduate Trainee |
| Affiliation |
The Calcutta Homoeopathic Medical College and Hospital |
| Address |
265, 266, Acharya Prafulla Chandra Road
Kolkata
WEST BENGAL
700009
India |
| Phone |
7688010574 |
| Fax |
|
| Email |
parionthenet@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rajat Chattopadhyay |
| Designation |
Principal and Administrator |
| Affiliation |
The Calcutta Homoeopathic Medical College and Hospital |
| Address |
265, 266, Acharya Prafulla Chandra Road
Kolkata
WEST BENGAL
700009
India |
| Phone |
9331041142 |
| Fax |
|
| Email |
dr.rajatchatterjee@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rajat Chattopadhyay |
| Designation |
Principal and Administrator |
| Affiliation |
The Calcutta Homoeopathic Medical College and Hospital |
| Address |
265, 266, Acharya Prafulla Chandra Road
WEST BENGAL
700009
India |
| Phone |
9331041142 |
| Fax |
|
| Email |
dr.rajatchatterjee@gmail.com |
|
|
Source of Monetary or Material Support
|
| The Calcutta Homoeopathic Medical College & Hospital, 265, 266, Acharya Prafulla Chandra Road, Kolkata 700009 |
|
|
Primary Sponsor
|
| Name |
The Calcutta Homoeopathic Medical College and Hospital |
| Address |
265, 266, Acharya Prafulla Chandra Road, Kolkata 700009 |
| 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 |
| Ritika Bose |
The Calcutta Homoeopathic Medical College and Hospital |
Special OPD (room no. 14), OPD no. 12, Dept. of Medicine, 265, 266, Acharya Prafulla Chandra Road
Kolkata
WEST BENGAL |
7688010574
parionthenet@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: M542||Cervicalgia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Identical-looking placebos plus concomitant care |
This group will receive placebo, 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 a clean tongue on an empty stomach; dosage and repetition will be maintained depending upon the individual requirement of the cases. All sundry items will be procured from a Good Manufacturing Practice (GMP) certified firm. All the participants will receive advice on concomitant measures, like physiotherapy (neck exercises, like alexander technique, isometric neck exercises, neck strengthening exercises, etc. along with hot fomentations) under the guidance of a trained physiotherapist. Duration of treatment: 3 months. Route of administration: Per oral |
| Intervention |
Individualized homeopathic medicines in centesimal potencies with 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 a clean tongue with empty stomach; dosage and repetition depend upon the individual requirement of the cases. Patients will be advised to refrain from handling the globules or from eating, drinking, smoking or brushing their 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 participants will receive advice on concomitant measures, like physiotherapy (neck exercises, like alexander technique, isometric neck exercises, neck strengthening exercises, etc. along with hot fomentations) under the guidance of a trained physiotherapist. Duration of treatment: 3 months. Route of administration: Per oral |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients suffering from chronic neck pain for 3 months or more.
2. Age between 10 and 65 years
3. Patients of either sex, including transgender
4. Literate patients; ability to read English, Bengali or Hindi and illiterate people will be interviewed by the investigators maintaining adequate privacy to fill up the scales or questionnaires
5. Willing to take part in the study and give written informed assent and/or consent voluntarily |
|
| ExclusionCriteria |
| Details |
1. Patients with known cervical radiculopathy (using spurling test) or having any severe pathological conditions causing neck pain. (e.g., cervical spondylosis, kyphosis, scoliosis, history of spinal injury, disc prolapse etc.)
2. Patients suffering from autoimmune disorders that impacts the musculoskeletal system (e.g., lupus, rheumatoid arthritis, ankylosing spondylitis)
3. Patients who are undergoing treatment with NSAIDs during 6 weeks prior to enrolment in the study.
4. Patients having history of any degenerative muscular or neurological condition that can impact the outcome measure (e.g., Parkinson’s disease, amyotrophic lateral sclerosis, multiple sclerosis, different myelopathy, muscular dystrophy, etc.)
5. Patients taking spinal corticosteroid injection within 6 months.
6. Patients suffering from active or chronic, systemic, or local infection or disease.
7. The chronic neck pain is due to any invasive malignant disease/neoplasia.
8. Vulnerable population - unconscious, non-ambulatory, too ill for consultation, differently abled, terminally ill or critically ill patients, institutionalized persons, mentally disabled people.
9. Diagnosed cases of unstable mental or psychiatric illness or other uncontrolled or life-threatening illness or serious illness (like cardiac disease) affecting the quality of life or organ failure.
10. Pregnant and postpartum women, lactation.
11. Patients with the habit of tobacco chewing and/or smoking, alcoholism and/or any other forms of substance abuse and/or dependence.
12. Self-reported immune-compromised condition.
13. Already been in homeopathic treatment for any chronic illness for the last 6 months.
14. Simultaneous participation in any other clinical trial |
|
|
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 |
| Pain Detect Questionnaire (PDQ) |
At baseline, every month, up to 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| EQ-5D-5L questionnaire |
At baseline, every month, up to 3 months |
| EQ-5D-5L VAS |
At baseline, every month, up to 3 months |
|
|
Target Sample Size
|
Total Sample Size="74"
Sample Size from India="74"
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)
|
03/05/2023 |
| 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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
None yet |
|
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 - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
- 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 [parionthenet@gmail.com].
- For how long will this data be available start date provided 01-01-2026 and end date provided 31-12-2030?
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
|
The WHO Global Burden of Disease study showed that neck pain is the 8th ranked
reason for most years lived with disability for 15–19 year old of any health
condition, which is higher than well-known adolescent public health problems. The
impact of neck pain is significant not just for the individual, but also for
industry and society. This 3-months, double-blind, randomized (1:1), placebo-controlled trial of individualized homeopathic medicines against placebos will be carried out at The Calcutta Homoeopathic Medical College & Hospital on 74 participants with chronic neck pain. Primary outcome is Pain Detect Questionnaire (PDQ); secondary outcome is EQ-5D-5L questionnaire and VAS scores; all to be measured at baseline, and every month, up to 3 months. Comparative analysis will be carried out to detect group differences. Results will be published in scientific journals. |