| CTRI Number |
CTRI/2025/03/081566 [Registered on: 03/03/2025] Trial Registered Prospectively |
| Last Modified On: |
27/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Treatment of Cervical Spondylosis with Homoeopathic medicine |
|
Scientific Title of Study
|
Assessment of likelihood ratio of four symptoms of Rhododendron Chrysanthum in patients of cervical spondylosis |
| 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 Vighnesh K |
| Designation |
Postgraduate trainee |
| Affiliation |
National Institute of Homoeopathy |
| Address |
National Institute of Homoeopathy GE block sector 3 Kolkata 700106 West Bengal
Department of Homoeopathic Materia Medica
Opd room no 18
North Twentyfour Parganas WEST BENGAL 700106 India |
| Phone |
7907216685 |
| Fax |
|
| Email |
vighnesh.vipinesh@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Vighnesh K |
| Designation |
Postgraduate trainee |
| Affiliation |
National Institute of Homoeopathy |
| Address |
National Institute of Homoeopathy GE block sector 3 Kolkata 700106 West Bengal
Department of Homoeopathic Materia Medica
Opd room no 18
North Twentyfour Parganas WEST BENGAL 700106 India |
| Phone |
7907216685 |
| Fax |
|
| Email |
vighnesh.vipinesh@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Swapan Paul |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Homoeopathy |
| Address |
National Institute of Homoeopathy GE block sector 3 Kolkata 700106 West Bengal
Department of Homoeopathic Materia Medica
Opd room no 18
North Twentyfour Parganas WEST BENGAL 700106 India |
| Phone |
9830148968 |
| Fax |
|
| Email |
drspaul.2007@gmail.com |
|
|
Source of Monetary or Material Support
|
| Self Dr Vighnesh k
National institute of Homoeopathy
Materia Medica department
Block GE Sector 3 Salt Lake City Kolkata west Bengal India 700106 |
|
|
Primary Sponsor
|
| Name |
self Dr Vighnesh k |
| Address |
National Institute of Homoeopathy GE block sector 3 Kolkata 700106 West Bengal
Department of Homoeopathic Materia Medica
Opd room no 18 |
| Type of Sponsor |
Other [self Dr Vighnesh k] |
|
|
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 Vighnesh k |
National Institute of Homoeopathy |
National Institute of Homoeopathy GE block sector 3 Kolkata 700106 West Bengal
Department of Homoeopathic Materia Medica
Opd room NO 18 North Twentyfour Parganas WEST BENGAL |
7907216685
vighnesh.vipinesh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical committee of National Institute of Homoeopathy |
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 |
| Intervention |
CONSTITUTIONAL HOMOEOPATHIC MEDICIN |
DOSAGE IS SELECTED BASED ON SUSCEPTABILITY AND HOMOEOPATHIC PRINCIPLE
DURATION IS 4 MONTHS
ADMINISTRATION ORAL ROUTE |
| Comparator Agent |
nill |
nill |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Patients suffering from cervical spondylosis verified by clinical examination and x ray
Patients aged 18 to 75 both male and female
Subjects of all socioeconomic status all religions
Ability to read either Bengali Hindi or English
Patients giving written consent to participate in the study
Subjects who agree to comply with protocol
Subjects who agree to undergo laboratory investigations whenever required |
|
| ExclusionCriteria |
| Details |
Patients with unstable psychiatric disorder
Pregnant women and lactating women
Immune compromised state
Substance abuse or dependence
Unwilling to participate or to comply with study requirements
Too unwell to take part
Declined to provide consent
Advanced case of cervical spondylosis that require surgical correction
Patients who has taken Homoeopathic medicine for any chronic illness within 3 months |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
The expected outcome will be the prevalence of the four symptoms is higher in the population that suffering from cervical spondylosis and improved by RHODODENDRON
CHRYSANTHUM than in the rest of population |
base line and 4 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Homoeopathic medicines are effective in cervical spondylosis |
baseline and 4 months |
|
|
Target Sample Size
|
Total Sample Size="100" Sample Size from India="100"
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)
|
10/03/2025 |
| 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 Yet Recruiting |
| 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
|
Cervical spondylosis is a degenerative disorder of the cervical spine that affects many people. It is caused by the deterioration of the cervical spine’s intervertebral discs and facet joints. Neck discomfort has a point prevalence ranging from 0.4 percent to 41.5 percent in the general population whereas the 1-year incidence varies between 4.8 percent to 79.5 percent and the lifetime prevalence can be as high as 86.8 percent. The majority of people with spondylosis abnormalities of the cervical spine on radiographic imaging are asymptomatic. While 25 percentage of people under the age of 40 exhibit some indication of degenerative changes. This number increases to 50 percentage in people over the age of 40 and 85 percentage in those over the age of 60. C6 to C7 is the most commonly impacted level followed by C5 to C6. Moreover neck pain is the most prevalent symptom of symptomatic cervical spondylosis. Research question is whether the prevalence of four predefined symptoms is higher in the population that is suffering from cervical spondylosis and is improved by RHODODENDRON CHRYSANTHUM than in the rest of the population or not. The primary objective is to assess the prevalence of selected symptoms of RHODODENDRON CHRYSANTHUM in population that suffering from cervical spondylosis and improved by RHODODENDRON CHRYSANTHUM when comparing with rest of the populations.Secondary objective is to evaluate the effectiveness of Homoeopathic medicines in cervical spondylosis. It is an open and prospective clinical study will be conducted among the Out patient and In patient Department of National Institute Of Homoeopathy (NIH), Kolkata. Samples will be selected as per below mentioned eligibility criteria and each patient will be enrolled after taking detail appropriate consent. Duration of study will be for 18 months and treatment of each patient will be continued for a period of 4 months. |