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CTRI Number  CTRI/2023/09/057285 [Registered on: 06/09/2023] Trial Registered Prospectively
Last Modified On: 20/10/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Other 
Public Title of Study   Homoeopathic management in treatment of cervical spondylosis 
Scientific Title of Study   To assess the effect of homoeopathic management through individualization in treatment of cervical spondylosis –a prospective 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  Bhatiya Gayatri 
Designation  MD Homoeopathy Scholar 
Affiliation  Jawaharlal Nehru Homoeopathic Medical College 
Address  Jawaharlal Nehru Homoeopathic Medical College At Post Limda, Ta: Waghodia, Dist: Vadodara

Vadodara
GUJARAT
391760
India 
Phone  9725382013  
Fax    
Email  bhatiyagayatri96@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. Mayank Roy 
Designation  Associate Professor 
Affiliation  Jawaharlal Nehru Homoeopathic Medical College 
Address  Jawaharlal Nehru Homoeopathic Medical College At Post Limda, Ta: Waghodia, Dist: Vadodara

Vadodara
GUJARAT
391760
India 
Phone  7405002111  
Fax    
Email  dr.mayankroy@gmail.com  
 
Details of Contact Person
Public Query  
Name  Bhatiya Gayatri 
Designation  MD Homoeopathy Scholar 
Affiliation  Jawaharlal Nehru Homoeopathic Medical College 
Address  Jawaharlal Nehru Homoeopathic Medical College At Post Limda, Ta: Waghodia, Dist: Vadodara

Vadodara
GUJARAT
391760
India 
Phone  9725382013  
Fax    
Email  bhatiyagayatri96@gmail.com  
 
Source of Monetary or Material Support  
Jawaharlal Nehru Homoeopathic Medical College and Hospital 
 
Primary Sponsor  
Name  NIL  
Address  NA 
Type of Sponsor  Other [SELF] 
 
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 Gayatri Bhatiya  Jawaharlal Nehru Homoeopathic medical college and hospital  Dept. of organon of medicine, Jawaharlal Nehru Homoeopathic Medical College, PARUL UNIVERSITY, Limda, Vadodara.
Vadodara
GUJARAT 		 9725382013

bhatiyagayatri96@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Jawaharlal Nehru Homoeopathic Medical College and Hospital Institutional Ethics Commitee for Human Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M47||Spondylosis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Individualised Homoeopathic Medicine  Intervention is planned as administering indicated homoeopathic medicine according to case or condition. In this potency each dose shall consist of 4-5 globules (no.30) of cane sugar, medicated with a single drop of the indicated medicine (preserved in 90% v/v ethanol), to be taken orally on clean tongue with empty stomach, dosage and repetition depending upon the individual requirement of the cases. Intervention of medicine will be for 6 months for each patient. 
Comparator Agent  NA  NA 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Diagnosis based on clinical presentation. 
 
ExclusionCriteria 
Details  â–ª Cases with malignant diseases and Trauma.
â–ª Cases complicated with systemic disorders.
▪ Life –threatening complications are excluded in this study.
â–ª Pregnant and lactating women. 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To Know about the utility of individualization in homoeopathic treatment of cervical spondylosis.  12 weeks, 24 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
To clinically assess treatment outcome in cases of cervical spondylosis using Neck Disability index scale  12 weeks, 24 weeks 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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   Phase 2 
Date of First Enrollment (India)   15/09/2023 
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)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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 the osteoarthritis of cervical spine. It is characterized by degeneration of intervertebral discs and osteophytes formation. Nowadays, peoples sedentary lifestyle has become much dominated by continuous utilization of electronic gadgets i.e., watching mobile, computers, laptop screen for extended hours, uncomforting posture of standing and sitting, improper food habits, excessive travelling in jerking condition, these all contribute to the problems of cervical spine like neck pain, stiffness and other neurological symptoms. 
Statistical data suggests that, the incidence of neck pain ranges between 10.4% to 21.3%. The overall prevalence of neck pain in the general population ranges between 0.4% to 86.8%. Prevalence of neck pain is generally higher in women, higher in urban areas compared with rural areas. In earlier days, it was the disease of late adulthood & old age but changing life-style causes disease even to younger generation. 
In Sec.111 of Organon of medicine, Dr. Hahnemann says, ‘Medicinal substances act in the morbid changes they produce in the healthy human body according to fixed, eternal laws of nature , and by virtue of these are enabled to produce certain, reliable disease symptoms each according to its own peculiar character.’ Homoeopathic system of medicine is based on individualization and it restore the patient’s health both physically and mentally to normal state. The purpose of this study is to evaluate the utility of homoeopathic individualization in the treatment of cervical spondylosis.
 
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