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CTRI Number  CTRI/2018/10/016156 [Registered on: 25/10/2018] Trial Registered Prospectively
Last Modified On: 03/10/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Homeopathic treatment of neck pain 
Scientific Title of Study   Efficacy of Individualized Homoeopathic Medicines in Treatment of Cervical Spondylosis: A Double-Blind, Randomized, Placebo-Controlled Clinical Trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
U1111-1221-8064  UTN 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Maneela Tomar 
Designation  Postgraduate Trainee 
Affiliation  National Institute of Homoeopathy 
Address  Block–GE, Sector–III, Salt Lake, Kolkata–700106

Kolkata
WEST BENGAL
700106
India 
Phone  9999554828  
Fax    
Email  maneela.t@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Netai Chand Bhowmick 
Designation  Professor 
Affiliation  National Institute of Homoeopathy 
Address  Department of Organon of Medicine and Homoeopathic Philosophy; Block–GE, Sector–III, Salt Lake, Kolkata–700106

Kolkata
WEST BENGAL
700106
India 
Phone  8001384666  
Fax    
Email  nitai.ch.bhowmik@gmail.com  
 
Details of Contact Person
Public Query  
Name  Netai Chand Bhowmick 
Designation  Professor 
Affiliation  National Institute of Homoeopathy 
Address  Department of Organon of Medicine and Homoeopathic Philosophy; Block–GE, Sector–III, Salt Lake, Kolkata–700106

Kolkata
WEST BENGAL
700106
India 
Phone  8001384666  
Fax    
Email  nitai.ch.bhowmik@gmail.com  
 
Source of Monetary or Material Support  
National Institute of Homoeopathy, Block – GE, Sector – III, Salt Lake, Kolkata – 700106 
 
Primary Sponsor  
Name  National Institute of Homoeopathy 
Address  Block – GE, Sector – III, Salt Lake, Kolkata – 700106 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
None  NA 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Maneela Tomar  National Institute of Homoeopathy  Department of Organon of Medicine, OPD room no 5 and 7, Block – GE, Sector – III, Salt Lake, Kolkata – 700106
Kolkata
WEST BENGAL 		 9999554828

maneela.t@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M478||Other spondylosis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Individualised homeopathic medicine in centesimal potency  Intervention is planned as administering indicated homoeopathic medicines in centesimal potencies. Each dose will be consisting of 4-6 cane sugar globules moistened with indicated medicines (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. All medicines will be procured from good manufacturing practice (GMP)-certified firm. Along with medicines, the intervention arm will receive physiotherapy and lifestyle modifications. Duration of study: 3 months. 
Comparator Agent  Placebo  This arm will receive placebo, indistinguishable from verum. Each dose of Placebo will be consisting of 4-6 cane sugar globules moistened with 90% v/v ethanol, to be taken orally on clean tongue with empty stomach; dosage and repetition depending upon individual requirement of the cases. Along with identical placebo, the intervention arm will receive physiotherapy and lifestyle modifications. Duration of therapy: 3 months. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1) Diagnosed cases of cervical spondylosis (ICD M47.8)
2) Age 18 to 65 years
3) Both sexes
4) Literate patients; able to read English and/or Bengali
5) Patients giving written consent to participate 
 
ExclusionCriteria 
Details  1) Patients having severe degenerative changes (e.g. disc prolapse, myelopathy, radiculopathy etc) as suggested by radiological findings
2) Patients undergoing homoeopathic treatment for any chronic disease within last 3 months
3) Diagnosed cases of unstable mental or psychiatric illness or other uncontrolled or life threatening illness affecting quality of life or any organ failure
4) Pregnancy and lactation
5) Substance abuse and/or dependence
6) Self-reported immune-compromised state 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
0-10 Numeric Rating Scales measuring intensity of pain, stiffness, numbness, tingling, weakness and vertigo  At baseline, every month up to month 3 
 
Secondary Outcome  
Outcome  TimePoints 
Neck Disability Index (NDI) measuring quality of life related to cervical spondylosis  At baseline, every month up to month 3 
 
Target Sample Size   Total Sample Size="140"
Sample Size from India="140" 
Final Enrollment numbers achieved (Total)= "140"
Final Enrollment numbers achieved (India)="140" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   01/11/2018 
Date of Study Completion (India) 16/06/2020 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   None yet; to be published 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary
Modification(s)  		 Cervical spondylosis (CS) is a degenerative condition of the cervical spine, with approximately 80-90% people suffering from disc degeneration by the age of 50 years. This trial attempts at evaluating efficacy of individualized homeopathic medicines (IHMs) against placebos in treatment of CS. A 3-months, double-blind, randomized, placebo-controlled trial was conducted at the Organon of Medicine outpatient department of National Institute of Homoeopathy, India. Patients were randomized to receive either IHMs (n=70) or identical-looking placebos (n=70) in the mutual context of concomitant conservative and standard physiotherapeutic care. Primary outcomes measures were 0-10 Numeric Rating Scales (NRSs) for pain, stiffness, numbness, tingling, weakness and vertigo, and secondary outcome was Neck Disability Index (NDI); measured at baseline and every month, until 3 months. Intention-to-treat sample was analyzed to detect group differences and effect sizes. Overall improvements were higher in the IHMs group than placebo, but group differences were statistically non-significant with small effect sizes (all P>0.05, two-ways repeated measure analysis of variance). After 2 months of timepoints, improvements observed in the IHMs group were significantly higher than placebo on few occasions (e.g., pain NRS: P<0.001; stiffness NRS: P=0.024; weakness NRS: P=0.003). Sulphur (n=21; 15%) was the most frequently prescribed medicine. No harms, unintended effects or any serious adverse events were reported from either group. An encouraging, but a non-significant direction of effect was elicited favoring IHMs against placebos in treatment of CS. 
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