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CTRI Number  CTRI/2019/11/021918 [Registered on: 07/11/2019] Trial Registered Prospectively
Last Modified On: 09/11/2022
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 medicines for low back pain 
Scientific Title of Study   Efficacy of individualized homeopathic medicines in treatment of lumbar spondylosis: Double-blind, randomized, placebo-controlled clinical trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
U1111-1242-9021  UTN 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Akshaya Prakash 
Designation  Postgraduate Trainee 
Affiliation  National Institute of Homoeopathy 
Address  Dept. of Organon of Medicine and Homoeopathic Philosophy, OPD room no. 5 and 7, Block GE, Sector III, Salt Lake

Kolkata
WEST BENGAL
700106
India 
Phone  8075760626  
Fax    
Email  akshayaprakash1989@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Nitai Chand Bhowmick 
Designation  Reader 
Affiliation  National Institute of Homoeopathy 
Address  Dept. of Organon of Medicine and Homoeopathic Philosophy, OPD room no. 7, Block GE, Sector III, Salt Lake

Kolkata
WEST BENGAL
700106
India 
Phone  8001384666  
Fax    
Email  nitai.ch.bhowmik@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Nitai Chand Bhowmick 
Designation  Reader 
Affiliation  National Institute of Homoeopathy 
Address  Dept. of Organon of Medicine and Homoeopathic Philosophy, OPD room no. 7, Block GE, Sector III, Salt Lake


WEST BENGAL
700106
India 
Phone  8001384666  
Fax    
Email  nitai.ch.bhowmik@gmail.com  
 
Source of Monetary or Material Support  
National Institute of Homoeopathy, Ministry of AYUSH, Govt. of India; Block GE, Sector III, Salt Lake, Kolkata 700106, West Bengal, India 
 
Primary Sponsor  
Name  National Institute of Homoeopathy 
Address  Block GE, Sector III, Salt Lake, Kolkata 700106, West Bengal, India 
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 
Akshaya Prakash  National Institute of Homoeopathy  Dept. of Organon of Medicine and Homoeopathic Philosophy, OPD room no. 5 and 7, Block GE, Sector III, Salt Lake
Kolkata
WEST BENGAL 
8075760626

akshayaprakash1989@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  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M478||Other spondylosis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Individualized homeopathic medicines in centesimal potencies  Intervention is planned as administering indicated homeopathic medicines in centesimal potencies, as decided appropriate to the case or condition. In centesimal scale, each dose shall consist of 6-8 globules (no. 10) 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. All medicines will be procured from a Good Manufacturing Practice (GMP)-certified firm. Along with medicines, the intervention arm will receive standardized guidelines for mutual physiotherapy and spinal exercises. Duration of therapy: 3 months. 
Comparator Agent  Placebo, indistinguishable in appearance from verum  Each dose of placebo shall consist of 6-8 globules (no. 20) of cane sugar, to be taken orally on clean tongue with empty stomach; dosage and repetition depending upon the individual requirement of the cases. Patients will receive standardized guidelines for mutual physiotherapy and spinal exercises. Duration of therapy: 3 months. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Patients with radiological diagnosis of lumbar spondylosis with mild to moderate degenerative radiological changes
2. Patients of age 18 to 65 years
3. Patients of both sexes
4. Literate patients, able to read and write in Bengali
5. Patients giving written consent to participate 
 
ExclusionCriteria 
Details  1. Patients having severe degenerative changes as found in radiological findings
2. Patients having major disorder associated with lumbar spondylosis
3. Patients undergoing homeopathic treatment for any chronic disease within last 3 months.
4. Diagnosed cases of unstable mental or psychiatric illness or other uncontrolled or life - threatening illness affecting quality of life or any organ failure
5. Pregnancy and lactation
6. Substance abuse and/or dependence
7. Self-reported immune-compromised state 
 
Method of Generating Random Sequence   Permuted block randomization, variable 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Oswestry low back pain questionnaire  At baseline, and every month, up to 3 months 
 
Secondary Outcome  
Outcome  TimePoints 
Roland Morris questionnaire  At baseline, and every month, up to 3 months 
McGill pain questionnaire short form (SF-MPQ)  At baseline, and every month, up to 3 months 
 
Target Sample Size   Total Sample Size="66"
Sample Size from India="66" 
Final Enrollment numbers achieved (Total)= "55"
Final Enrollment numbers achieved (India)="55" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   18/11/2019 
Date of Study Completion (India) 22/06/2021 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Results arising out of the trial will be published in scientific journal in future 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary
Modification(s)  

Lumbar spondylosis (LS) is a degenerative disorder of the lumbar spine. Despite substantial research efforts, no gold-standard treatment for LS has been identified. The efficacy of individualized homeopathic medicines (IHMs) in LS has remained under-researched. In this study, the efficacy of IHMs was compared with identical-looking placebos in the treatment of LS. A double-blind, randomized (1:1), placebo-controlled trial was conducted at the National Institute of Homoeopathy, West Bengal, India. Patients were randomized to receive IHMs or identical-looking placebos, along with standardized concomitant care for both the groups. The Oswestry low back pain and disability questionnaire (ODQ) was the primary outcome; the Roland Morris questionnaire (RMQ) and the short form McGill pain questionnaire (SF-MPQ) were the secondary outcomes; each was measured at baseline and every month for 3 months. The intention-to-treat (ITT) sample was analyzed to detect any inter-group differences using two-ways repeated measures analysis of variance models overall and by unpaired t-tests at different time points. Enrolment was stopped prematurely because of time restrictions; 55 patients were randomized (verum: 28; control: 27); 49 were analyzed by ITT (verum: 26; control: 23). Inter-group differences in ODQ, RMQ and SF-MPQ total scores at 3 months were not statistically significant. SF-MPQ total score after 2 months revealed statistical significance, favoring IHMs against placebos. Some of the SF-MPQ subscales at different time points were also significant. Rhus toxicodendron, Sulphur and Pulsatilla nigricans were the most frequently indicated medicines. Owing to failure in detecting a statistically significant effect for the primary outcome and in recruiting a sufficient number of participants, our trial remained inconclusive.

 
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