| CTRI Number |
CTRI/2024/11/077201 [Registered on: 21/11/2024] Trial Registered Prospectively |
| Last Modified On: |
20/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Homeopathy
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Role of homoeopathic medicines along with Physiotherapy in the treatment of Cervical Spondylosis |
|
Scientific Title of Study
|
Effectiveness of Homoeopathic Medicines with Physiotherapy
as an adjunct in the management of Cervical Spondylosis: A Randomised Placebo Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Bhawna |
| Designation |
PG Scholar |
| Affiliation |
Dr B R Sur Homoeopathic Medical College, Hospital & Research Centre, Delhi - 110021 |
| Address |
Department of Homoeopathic Materia Medica, 3rd floor, Dr. B.R. Sur Homoeopathic Medical College, Hospital and Research Centre, Nanakpura, Motibagh, New Delhi-110021
South West
DELHI
110021
India |
| Phone |
8700088525 |
| Fax |
|
| Email |
bhawna9359@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr U Rajeev Nair |
| Designation |
Professor & HOD, Department of Homoeopathic Materia Medica |
| Affiliation |
Dr B R Sur Homoeopathic Medical College, Hospital & Research Centre |
| Address |
Department of Homoeopathic Materia Medica, Dr B R Sur Homoeopathic Medical College, Hospital & Research Centre, Motibagh, Nanakpura, Delhi
South West
DELHI
110021
India |
| Phone |
9868393285 |
| Fax |
|
| Email |
drrajivh@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bhawna |
| Designation |
PG Scholar |
| Affiliation |
Dr B R Sur Homoeopathic Medical College, Hospital & Research Centre, Delhi - 110021 |
| Address |
Department of Homoeopathic Materia Medica, 3rd floor, Dr. B.R. Sur Homoeopathic Medical College, Hospital and Research Centre, Nanakpura, Motibagh, New Delhi-110021
South West
DELHI
110021
India |
| Phone |
8700088525 |
| Fax |
|
| Email |
bhawna9359@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. B.R. Sur Homoeopathic Medical College, Hospital and Research Centre, Delhi-110021 |
|
|
Primary Sponsor
|
| Name |
Dr Bhawna |
| Address |
Department of Materia Medica, 3rd floor, Dr B R Sur Homoeopathic Medical College, Hospital & Research Centre, Nanakpura, Motibagh, New Delhi - 110021, India |
| 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 Bhawna |
Dr B R Sur Homoeopathic Medical College, hospital & Research Centre |
Dr B R Sur Homoeopathic Medical College, hospital & Research Centre, Motibagh, Nanakpura, New Delhi - 110021
South West
DELHI |
8700088525
bhawna9359@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: M47||Spondylosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Homoeopathic Medicines with Physiotherapy |
Homoeopathic medicine will be administered in centesimal potencies, selected according to homoeopathic principles along with physiotherapy.The dose and repetition will be decided as per the requirement of each case. The route of administeration will be oral, in the form of globules. Each patient will first be assessed by a physiotherapist, who will then provide a personalized physiotherapy plan based on their assessment. Duration : 6 months |
| Comparator Agent |
Placebo with Physiotherapy |
Identical looking placebo in globules form will be given along with physiotheraphy. Each patient will first be assessed by a physiotherapist, who will then provide a personalized physiotherapy plan based on their assessment. Duration : 6 months |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients presenting with signs and symptoms of cervical spondylosis and characteristic X ray changes. 2. Age group 25 to 65 years of both sexes. 3. Cases with no disability (0-4) to moderate disability (15-24) according to Oswestry neck disability index. |
|
| ExclusionCriteria |
| Details |
1. Patients with advanced degenerative changes in cervical region requiring surgical intervention.
2. Patient with serious complicated systemic illness.
3. Pregnant and lactating females.
4. Patients who are under any other treatment for the same complaint.
5. Diagnosed case of mental illness / psychiatric/
other uncontrolled/ life threatening illness affecting quality of life/ any organ failure.
6. Unwilling to take part and not giving consent to join the study or unable to read the patient information sheet. Patients unable to comply with study protocol. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The reduction in intensity of neck pain among patients with cervical spondylosis taking homoeopathic medicines with physiotherapy and those taking physiotherapy alone using Visual Analogue Scale (VAS). |
Each case will be reviewed every two weeks, with pain intensity measured using the Visual Analog Scale (VAS) at baseline and then at every two weeks, till 6 months (24th week) of treatment. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The improvement in disability among patients with cervical spondylosis taking homoeopathic medicines with physiotherapy & those taking physiotherapy alone using Oswestry Neck Disability Index (NDI) as outcome measure. |
Assessment with Neck disability questionnaire will be done at baseline, at 3 month(12th week) & then at 6 month (24th week) of treatment. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 3 |
|
Date of First Enrollment (India)
|
01/12/2024 |
| 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="0"
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
|
This study is a randomized, placebo-controlled trial involving patients diagnosed with cervical spondylosis, confirmed by X-ray. Participants are divided into two groups based on randomization. One group will receive homeopathic medicine and physiotherapy, with homeopathic medicines administered in appropriate doses and potencies according to homeopathic principles, including repetition as needed. The other group will receive a placebo alongside physiotherapy. Each case will be reviewed every two weeks, with pain intensity measured using the Visual Analog Scale (VAS) at each visit. Disability will be assessed using the Oswestry Neck Disability Index at baseline, 3 months, and 6 months. |