| CTRI Number |
CTRI/2025/08/092902 [Registered on: 12/08/2025] Trial Registered Prospectively |
| Last Modified On: |
11/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Homeopathy for neck pain |
|
Scientific Title of Study
|
A double-blind, randomized, placebo-controlled trial of individualized homoeopathic medicines in managing neck disability in cervical spondylosis in adults |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1326-6018 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sayani Debnath |
| Designation |
Postgraduate Trainee |
| Affiliation |
D N De Homoeopathic Medical College and Hospital |
| Address |
Department of Homoeopathic Materia Medica, Room no- PG 2. 12 , Gobinda Khatick Road, Tangra, Kolkata
Kolkata
WEST BENGAL
700046
India |
| Phone |
9332612659 |
| Fax |
|
| Email |
sayani2659@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sayani Debnath |
| Designation |
Postgraduate Trainee |
| Affiliation |
D N De Homoeopathic Medical College and Hospital |
| Address |
Department of Homoeopathic Materia Medica, Room no- PG 2. 12 , Gobinda Khatick Road, Tangra , Kolkata
Kolkata
WEST BENGAL
700046
India |
| Phone |
9332612659 |
| Fax |
|
| Email |
sayani2659@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr Arpita Basu |
| Designation |
Professor |
| Affiliation |
D N De Homoeopathic Medical College and Hospital |
| Address |
Department of Homoeopathic Materia Medica, Room no- PG 2. 12 , Gobinda Khatick Road, Tangra , Kolkata
Kolkata
WEST BENGAL
700046
India |
| Phone |
9830273374 |
| Fax |
|
| Email |
drarpitasen@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 Sayani Debnath |
D N De Homoeopathic Medical College and Hospital |
Dept. of Homoeopathic Materia Medica,OPD No- PG-2, 12 Gobinda Khatick Road, Kolkata, West Bengal, 700046
Kolkata
WEST BENGAL |
9332612659
sayani2659@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, D N De Homoeopathic Medical College and Hospital,12 Gobinda Khatick Road, Kolkata, West Bengal, 700046 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M479||Spondylosis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Identical looking Placebo |
This arm will be given a placebo that looks exactly like verum. Four globules (number 40) of cane sugar, moistened with rectified spirit, are required for each dose of the placebo. The dosage and frequency of administration are determined by the specific needs of each case. Similar to the experimental arm, management directions will be provided.
Therapy lasts for three months. Both medications and placebos will be repackaged in
identical glass bottles, labeled with the medications name, potency, and code. They
will be administered based on a list of random numbers.Therapeutic exercises include ‘Isometric exercise’- Cervical flexion, Cervical extension, Right Lateral Flexion, Left Lateral Flexion, Right Rotation, Left Rotation.6 days a week for 4 consecutive weeks as 3 sets/day (morning, afternoon, evening), each set consisted of 6 movements, holding each movement for 10 s, and repeating each 5 times with a 5-s rest between each of them. In order to slow the progression of the condition, patients will be encouraged for healthy Eating includes increased fruit (fresh + dried), whole grains, lean proteins, and reduce added sugars/saturated fats decrease spinal pain.Every dietary prescription will be tailored to the participants socioeconomic and cultural backgrounds and will follow the dieticians instructions. |
| Intervention |
Individualized Homoeopathic Medicines |
IHMs will be used to treat the recruited individuals with cervical spondylosis.According to the situation or condition, the intervention will involve
delivering the relevant homoeopathic medicine in centesimal potencies.
Each dose on a centesimal scale consists of four globules (no.40) of cane sugar, medicated with the prescribed medication (kept in 90% v/v ethanol), and eaten orally on an empty stomach and clean tongue. The quantity and frequency of administration
depend on the specific needs of each case. Patients will be requested to suck the
globules instead of just swallowing them, and they will be told not to handle the
globules or eat, drink, smoke, or clean their teeth for 30 minutes after taking them.
Every time, a single customized medication will be provided, taking into consideration the patients location, feeling, modalities, concomitants, and presenting complaint.
Every medication and other item will be purchased from a company that has earned
Good Manufacturing Practice (GMP) certification. When necessary, provisions will be made to switch up the medications or potencies
and modify the dosage at follow-up appointments in accordance with the principles of classical homeopathy; these situations will be compared between groups.Therapeutic exercises include ‘Isometric exercise’- Cervical
flexion, Cervical extension, Right Lateral Flexion, Left Lateral Flexion, Right
Rotation, Left Rotation.6 days a week for 4 consecutive weeks as 3 sets/day (morning, afternoon, evening), each set consisted of 6 movements, holding each movement for 10 s, and repeating each 5 times with a 5-s rest between each of them. In order to slow the progression of the condition, patients will be encouraged
for healthy Eating includes increased fruit (fresh + dried), whole grains, lean proteins, and reduce added sugars/saturated fats decrease spinal pain.Every dietary prescription will be tailored to the participants socioeconomic and cultural backgrounds and will follow the dieticians instructions.
Duration of therapy: 3 months. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patient with age group 18-65 yrs.
1.Participants of either sex or transgender.
2.Patient suffering from Cervical Spondylosis verified by clinical examination as
well as X ray findings.
3.Patient with mild to moderate neck pain. according to NDI score 5-24 |
|
| ExclusionCriteria |
| Details |
1.Not providing with written informed consent of participation.
2.Severe degeneration of Cervical Spine with marked degeneration of vertebrae,
having neck trauma/fracture/history of surgery/congenital spinal abnormalities,
any systemic disease of bones and joints and other non- specific neck pain lesion.
3.Non-ambulant patients.
4.Immune compromised state.
5.Substance abuse or dependence
6.Too unwell to take part.
7.Patient with unstable psychiatric disorder.
8.Pregnancy and puerperal and Lactating women.
9.Patient with severe neck pain.
10.Undergoing homoeopathic treatment for any chronic disease within last 6 months.
11.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 |
| Neck Disability Index (NDI) |
Baseline, and every month,
up to 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Pain 0-10 Numerical Rating Scale (NRS) |
Baseline, and every month,
up to 3 months |
| Measure Yourself Medical Outcome Profile version 2 (MYMOP-2) |
Baseline, and every month,
up to 3 months |
|
|
Target Sample Size
|
Total Sample Size="126"
Sample Size from India="126"
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)
|
01/09/2025 |
| 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) |
Open to Recruitment |
|
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-identification.
- 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 [sayani2659@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
|
The osteo-cartilaginous components of the cervical spine are impacted by cervical spondylosis (CS), a chronic degenerative disorder of the spine. With a worldwide frequency that ranges from 10% to 17.6%, cervical spondylosis is a well-known public health issue that affects people of all ages and in a variety of nations . According to the global burden of disease study of 2013 , in 301 acute and chronic diseases and injuries in 188 countries, neck pain was one of the top 10 causes of years lived with disability.Many patients use complementary and alternative medicine (CAM), including homeopathy, to prevent, control, and manage their rheumatologic disorders. However, scientific research has not yet fully proven the efficacy of complementary and alternative medicine (CAM) as a treatment for rheumatologic illnesses, such as Cervical Spondylosis and the findings have remained unclear . Homeopathy may have immense potential to offer in successful treatment of pain of cervical spondylosis but the available data shows contradictory results . Under such circumstances, we intend to undertake this research project ‘A double blind, randomized, placebo-controlled trial of individualized homoeopathic medicines in managing neck disability in cervical spondylosis in adults’.A double-blind, randomized (2:1), placebo-controlled trial will be conducted on 126 adults who are suffering from neck disability due to cervical spondylosis at the outpatient’s department of D. N. De Homoeopathic Medical College and Hospital. Assessment will be done by Neck Deformity Index (NDI) [Primary outcome measure], Pain NRS scale [Secondary outcome measure], MYMOP-2 questionnaire [Secondary outcome measure] every month up to 3 months. Comparative analysis will be carried out to detect group differences. |