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CTRI Number  CTRI/2024/12/077877 [Registered on: 09/12/2024] Trial Registered Prospectively
Last Modified On: 06/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Single Arm Study 
Public Title of Study   Role of Individualized Homoeopathic Medicine in Cervical Spondylosis 
Scientific Title of Study   Effect of Individualized homoeopathic medicines on pain and health related quality of life in patients of cervical spondylosis : A single group, pre - post interventional study 
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 Piu Mondal 
Designation  Post Graduate Trainee 
Affiliation  Mahesh Bhattacharyya Homoeopathic Medical College and Hospital 
Address  Dr. B.N.Chakrabarty Sarani, Doomurjala, Howrah Department of Homoeopathic Materia Medica Room No- 9

Haora
WEST BENGAL
711104
India 
Phone  8697481522  
Fax    
Email  piu.bhms@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Trishita Basu 
Designation  Reader, Department of Homoeopathic Materia Medica 
Affiliation  Mahesh Bhattacharyya Homoeopathic Medical College and Hospital 
Address  Dr. B.N.Chakrabarty Sarani, Doomurjala, Howrah Department of Homoeopathic Materia Medica Room No - 9

Haora
WEST BENGAL
711104
India 
Phone  8334941727  
Fax    
Email  drtrishita85@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Trishita Basu 
Designation  Reader, Department of Homoeopathic Materia Medica 
Affiliation  Mahesh Bhattacharyya Homoeopathic Medical College and Hospital 
Address  Dr. B.N.Chakrabarty Sarani, Doomurjala, Howrah Department of Homoeopathic Materia Medica Room no - 9

Haora
WEST BENGAL
711104
India 
Phone  8334941727  
Fax    
Email  drtrishita85@gmail.com  
 
Source of Monetary or Material Support  
Mahesh Bhattacharyya Homoeopathic Medical College and Hospital Address - Dr.B.N.Chakrabarty Sarani, Doomurjala, Howrah PIN - 711104, Country - India 
 
Primary Sponsor  
Name  Mahesh Bhattacharyya Homoeopathic Medical College And Hospital 
Address  Dr. B.N.Chakrabarty Sarani, Doomurjala, Howrah PIN - 711104, State - West Bengal, Country - India 
Type of Sponsor  Government 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 
Dr Piu Mondal  Mahesh Bhattacharyya Homoeopathic Medical College and Hospital  Dr.B.N.Chakrabarty Sarani, Doomurjala,Howrah Department Of Homoeopathic Materia Medica Room No - 9
Haora
WEST BENGAL 		 8697481522

piu.bhms@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  
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  Individualized Homoeopathic Medicine  All patients enrolled in the study will be receiving homoeopathic medicine on the basis of individualization at frequency of 21-28 days interval for three months. Both centesimal and fifty millesimal potencies will be used. Doses of the medicine will be on the basis of condition of the patient.The medicines are to be taken through oral route. All medicine procured will be GMP certified. Along with medicines the patients will receive dietary advice. Diet Management according to individual patients requirements. Total duration of the treatment will be depending upon the condition of the patient. 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients of age group of 18-60 years.
Positive radiological findings for cervical spondylosis.
Patients willing to give consent. 
 
ExclusionCriteria 
Details  Co-morbid conditions like uncontrolled endocrine disorder, inflammatory rheumatic disorder or other life threatening illness affecting quality of life.

Neurological Diseases like Alzheimer disease, dementia.

Pregnant and lactating women.

Undergoing Homoeopathic treatment for any other Clinical condition. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To understand the impact on pain by using Numeric Pain Rating Scale.   Each Patients will be assessed at the baseline( before start of the treatment i.e. 0 weeks) and three months( 12 weeks after the start of treatment) after intervention 
 
Secondary Outcome  
Outcome  TimePoints 
To understand the imapct on quality of life by EQ-5D-5L questionnaires.  Each Patients will be assessed at the baseline(before the start of treatment i.e. 0 weeks) & three months( after 12 weeks) after intervention 
 
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)   18/12/2024 
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="6"
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   INTRODUCTION: Cervical Spondylosis (ICD-11, 2023; FA8Z)  is a characterized by degenerative disorder of cervical spine, intervertebral discs, ligaments and cartilaginous material and osteophyte formation. Spondylosis may be associated with neurological dysfunction.

“SPONDYLO” is a Greek word meaning vertebra and spondylosis generally mean changes in the vertebral joint characterized by increasing degeneration of the intervertebral disc with subsequent changes in the bones and soft tissues.

It affects the vertebral bodies and intervertebral discs of the neck and leads to herniated intervertebral disks, osteophytes, and ligament hypertrophy. This may eventually cause compression of the nerve roots and spinal cord. The typical signs and symptoms of cervical spondylosis include headaches, neck stiffness, vertigo, numbness, weakness, and tingling in the arms and/or neck, as well as pain in these areas.

The typical age range for individuals with cervical spondylosis is 40–60 years old, with a male to female ratio of 3:1. The highest frequency was seen between 40 to 49 years of age. Men the majority was seen starting around age 20.

"Vertebral osteophytosis secondary to degenerative disc disease" is the definition of spondylosis. Spondylosis is not the same as inflammatory diseases that cause osteophyte development, which are all referred to as arthritis.
Age-related degradation of the cervical spinal components and intervertebral disc is the main risk factor and contributor to the incidence of cervical spondylosis. Narrowing of the spinal canal and intervertebral foramina is caused by degenerative alterations in surrounding structures, such as the facets joints, uncovertebral joints, posterior longitudinal ligament (PLL), and ligamentum flavum. Axial neck discomfort, cervical myelopathy, and cervical radiculopathy are the three clinical symptoms that cervical spondylosis manifests as a result of compression of the spinal cord, spinal vasculature, and nerve roots. Certain sports activities like rugby, soccer, and horseback riding, as well as congenitally narrow vertebral canals and dystonic cerebral palsy that affects the cervical musculature, can all lead to an accelerated disease process and early-onset cervical spondylosis.

The majority of patients with radiographic imaging-detected spondylotic alterations of the cervical spine are asymptomatic; 25% of patients under 40, 50% of patients over 40, and 85% of patients over 60 exhibit some degree of degenerative abnormalities. Levels C6–C7 are the most commonly impacted, followed by C5–C6. The most prevalent symptom of symptomatic cervical spondylosis is neck pain. Neck discomfort in the general population can have a point prevalence of 0.4% to 41.5%, a 1-year incidence of 4.8% to 79.5%, and a lifetime prevalence of up to 86.8%. Low back and neck pain is still the primary cause of years lived with disability (YLD) and the fourth most common cause of impairment, according to the Global Burden of Disease report from 2015.

In homoeopathy, the idea of "individualization" is embraced, meaning that different patients with the same illness can be treated with different medicines based on their unique physical, mental, and miasmatic symptoms.

RESEARCH QUESTIONS: Is individualized homoeopathic medicines are effective on pain along with health related quality of life in the patients suffering from cervical spondylosis?

HYPOTHESIS:

A) Null Hypothesis (H0): There is no significant role of individualized homoeopathic medicines in the treatment of Cervical Spondylosis.

B) Alternative Hypothesis (HA): Individualized homoeopathic medicines have a significant role in the treatment of Cervical Spondylosis.

JUSTIFICATION OF STUDY :

Hogg-Johnson et al. conducted a review of the epidemiology of neck pain and discovered that the annual prevalence of neck pain in the general adult population and workers ranged from 12.1% to 71.5%. In the allopathic system of medication consists of topical analgesics, NSAIDs, analgesics and injections which have side effects that are more serious than the illness.

In modern era the prevalence of Cervical Spondylosis in adult age group is rising very high due to working conditions, (such as posture and neck muscle endurance) have not been prospectively investigated specifically in office workers . According to the Global Burden of Disease 2015, neck pain remain the leading cause of years lived with disability (YLD) and the fourth leading cause of disability-adjusted life years (DALYs).

Besides a large population of male and female patients are attended in OPD of Mahesh Bhattacharyya homoeopathic medical college and hospital daily with high prevalence of CS in adult age group. So, it will be an ideal set up to conduct the study.

 
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