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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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. 
 
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