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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  
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 
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  
Status 
Not Applicable 
 
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. 
 
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