| CTRI Number |
CTRI/2024/09/074192 [Registered on: 23/09/2024] Trial Registered Prospectively |
| Last Modified On: |
20/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Management of cervical spondylosis using homoeopathic medicines |
|
Scientific Title of Study
|
Assessing the effectiveness of homoeopathic medicine for pain management in cervical spondylosis using visual analogue scale |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vineetha v |
| Designation |
PG Scholar |
| Affiliation |
White memorial homoeo medical college and hospital |
| Address |
Department of practice of medicine
White memorial homoeo medical college and hospital Attor Veeyanoor Kanyakumari District
Kanniyakumari TAMIL NADU 629177 India |
| Phone |
9400898887 |
| Fax |
|
| Email |
dr.vineethatinu28@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr R Richard franklin |
| Designation |
Professor and HOD |
| Affiliation |
White memorial homoeo medical college and hospital Attor veyyanoor kanyakumari district |
| Address |
Department of practice of medicine
White memorial homoeo medical college and hospital Attor
Veyyanoor Kanyakumari District
Kanniyakumari TAMIL NADU 629177 India |
| Phone |
9400898887 |
| Fax |
|
| Email |
rrfranklin24@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Vineetha v |
| Designation |
PG Scholar |
| Affiliation |
White memorial homoeo medical college and hospital |
| Address |
Department of practice of medicine
White memorial homoeo medical college and hospital Attor Veeyanoor Kanyakumari District
Kanniyakumari TAMIL NADU 629177 India |
| Phone |
9400898887 |
| Fax |
|
| Email |
dr.vineethatinu28@gmail.com |
|
|
Source of Monetary or Material Support
|
| White memorial homoeo medical college and hospital Attoor Veyyanoor kanyakumari district
Tamilnadu 629177 India |
|
|
Primary Sponsor
|
| Name |
White memorial homoeo medical college and hospital Attoor Veyyanoor Kanyakumari district |
| Address |
White memorial homoeo medical college and hospital Attoor Veyyanoor kanyakumari district
Tamilnadu 629177 India |
| Type of Sponsor |
Private 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 |
| Vineetha v |
White memorial homoeo medical college and hospital |
Practice of Medicine Department OPD IPD and Periphery Centers of WMHMCH kanyakumari
TAMILNADU Kanniyakumari TAMIL NADU |
9400898887
dr.vineethatinu28@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe White memorial homoeo medical college and hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M478||Other spondylosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualised homoeopathic medicines |
Each case will be reviewed after 2 weeks or as per their need in case of emergency and followed for a period of 6 months from beginning of study |
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Patients presenting with clinical symptoms of cervical spondylosis
subjects of both sexes
patients aged above 30 years and below 55 years |
|
| ExclusionCriteria |
| Details |
patients with congenital structural deformity of spine
patients with other systemic illness
pregnant and lactating women are excluded
patient with history of trauma. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the changes in VAS score in patients with cervical spondylosis before and after administration of homoeopathic similimum |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to find out the most commonly indicated medicines for cervical spondylosis |
1 year |
|
|
Target Sample Size
|
Total Sample Size="30" Sample Size from India="30"
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
|
N/A |
|
Date of First Enrollment (India)
|
01/10/2024 |
| 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
|
“ASSESSING THE EFFECTIVENESS OF HOMOEOPATHIC MEDICINES FOR PAIN MANAGEMENT IN CERVICAL SPONDYLOSIS USING VISUAL- ANALOGUE SCALE†Cervical spondylosis, also known as cervical syndrome, is a degenerative pathological disease . It is characterized by degeneration of the intervertebral disc and osteophyte formation . According to ICD 10 classification of WHO, cervical spondylosis is listed under code, M 47. The majority of individuals with cervical spine spondylotic changes on radiographic imaging do not experience symptoms. Among those under 40, about 25% show such changes, while the figure rises to 50% for those over 40, and 85% for those over 60, indicating evidence of degenerative changes . It often manifests as persistent neck pain with radiation to the occiput or upper limbs, accompanied by stiffness, numbness, and weakness in the limbs . As the pace of life continues to accelerate, the popularity of cars, computers and other tools, the incidence of cervical spondylosis is increasing, which has a certain impact on the normal life and work of patients. According to the latest census report, the incidence of cervical spondylosis ranges from 3.8% to 17. And with the increase in life expectancy, the problem of cervical spondylosis is becoming more and more prominent. Although treatments such as NSAIDs, muscle relaxants, analgesics, exercises, and complementary therapies are available for cervical spondylosis, none offer complete effectiveness. Individualization is one of the fundamental principles of homoeopathy. Individualistic homoeopathic medicines are effective in the pain management of cases presenting with cervical spondylosis. |