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CTRI Number  CTRI/2024/12/077622 [Registered on: 03/12/2024] Trial Registered Prospectively
Last Modified On: 13/12/2024
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 back pain 
Scientific Title of Study   Efficacy of individualized homoeopathic medicines in the treatment of sciatica pain in adults: A Double-blind, randomized, placebo-controlled trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
U1111-1315-8861  Other 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Khushboo Pandey 
Designation  Postgraduate Trainee 
Affiliation  D N De Homoeopathic Medical College and Hospital 
Address  Dept. of Materia Medica, OPD no. PG 2 and PG 5, 12, Gobinda Khatick Road

Kolkata
WEST BENGAL
700046
India 
Phone  8777318316  
Fax    
Email  khusi4n@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Arpita Basu 
Designation  Professor 
Affiliation  D N De Homoeopathic Medical College and Hospital 
Address  Dept. of Materia Medica, OPD no. PG 2, 12, Gobinda Khatick Road

Kolkata
WEST BENGAL
700046
India 
Phone  9830273374  
Fax    
Email  drarpitasen@gmail.com  
 
Details of Contact Person
Public Query  
Name  Arpita Basu 
Designation  Professor 
Affiliation  D N De Homoeopathic Medical College and Hospital 
Address  Dept. of Materia Medica, OPD no. PG 2, 12, Gobinda Khatick Road

Kolkata
WEST BENGAL
700046
India 
Phone  9830273374  
Fax    
Email  drarpitasen@gmail.com  
 
Source of Monetary or Material Support  
D N De Homoeopathic Medical College and Hospital 12 Gobinda Khatick Road Kolkata 700046 
 
Primary Sponsor  
Name  D N De Homoeopathic Medical College and Hospital 
Address  12 Gobinda Khatick Road Kolkata 700046 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
Nil  NA 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Khushbu Pandey  D N De Homoeopathic Medical college and Hospital  Dept of Materia Medica OPD no. PG2 and PG5, 12, Gobinda khatick Road, Kolkata 700046
Kolkata
WEST BENGAL 		 8777318316

khusi4n@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee of D N De Homoeopathic Medical College & Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M543||Sciatica,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Identical-looking placebo plus concomitant care  This arm will be given a placebo that looks identical in appearance to the verum. Each dose of placebo shall consist of 4 globules (no. 40) of cane sugar, moistened with rectified spirit, to be taken orally on clean tongue with empty stomach; dosage and repetition depending upon the individual requirement of the cases. Management guidelines will be given as in the experimental arm. Duration of therapy: 3 months. Both medicines and placebos will be re-packed in identical glass bottles and labelled with code, name of the medicine, potency and will be dispensed according to the random number list. Concomitant care measures include postural modifications, ergonomic adjustments, applying hot fomentations to the back, using firm bed, spinal extensor exercises, yoga therapy, and avoiding lifting heavy weights. Route of administration: per oral. Duration of therapy: 3 months 
Intervention  Individualized homeopathic medicines in individualized dosage plus concomitant care  Intervention is planned as administering the indicated homoeopathic remedy in centesimal potencies, as decided appropriate to the case or condition. In centesimal scale, each dose shall consist of 4 globules (no. 40) of cane sugar, medicated with 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 requirements of the cases. Patients will be advised to refrain from handling the globules or from eating, drinking, smoking or brushing teeth within 30 minutes of taking the globules and will be asked to suck the globules rather than simply swallowing those. Single individualized medicine will be prescribed on each occasion, taking into account presenting symptom totality, clinical history details, constitutional features, miasmatic expressions, repertorization using HOMPATH /RADAR software in each case with due consultation of Materia Medica and due consensus among three homoeopaths. All medicines and sundry will be procured from a Good Manufacturing Practice (GMP)-certified firm. Provision will be kept to change the medicines or potencies and adjust the dosage in subsequent visits whenever required following the principles of classical homeopathy and such instances will be compared between groups. Concomitant care measures include postural modifications, ergonomic adjustments, applying hot fomentations to the back, using firm bed, spinal extensor exercises, yoga therapy, and avoiding lifting heavy weights. Route of administration: per oral. Duration of therapy: 3 months 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Patients of age group 18 to 65 years
2. Either sex or transgender
3. Cases experiencing low back pain radiating to the lower limb (unilateral or bilateral) for 3 month or more (2018/2019 ICD-10-CM diagnosis code M54.3), confirmed by straight leg raising (SLR) test and as diagnosed clinically by the consultant orthopaedic and spine surgeon, and/or MRI as and when necessary 
 
ExclusionCriteria 
Details  1. Denying informed consent
2. Cases suffering from uncontrolled systemic disease or infections.
3. Diagnosed or suspected cases of malignancy or metastasis or any SOL in spine, red flag signs like progressive neurological deficit, bowel/bladder dysfunction, unexplained weight loss, recent trauma, and infection.
4. Having a history of low back surgery in the past 6 months.
5. Undergoing any medicinal treatment during 6 weeks before enrolment in the study;
6. Pregnancy, nursing mothers, and puerperal women.
7. Self-reported immune-compromised state.
8. Patients with psychiatric disease.
9. Chewing tobacco, smoking, alcoholism, substance misuse in any form, and/or dependence (TAPS tool)
10. Receiving homoeopathic treatment for a chronic illness all through the previous three months.
11. Simultaneously taking part in any other clinical trial. 
 
Method of Generating Random Sequence   Permuted block randomization, variable 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
Roland Morris Pain and Disability Questionnaire (RMPDQ)  Baseline, and every month, up to 3 months 
 
Secondary Outcome  
Outcome  TimePoints 
Short Form McGill Pain Questionnaire (SF-MPQ)  Baseline, and every month, up to 3 months 
Oswestry Low Back Pain Disability Questionnaire (OLBPDQ)  Baseline, and every month, up to 3 months 
Measure Yourself Medical Outcome Profile v.2 (MYMOP-2)  Baseline, and every month, up to 3 months 
 
Target Sample Size   Total Sample Size="72"
Sample Size from India="72" 
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/ Phase 3 
Date of First Enrollment (India)   16/12/2024 
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)
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [khusi4n@gmail.com].

  6. For how long will this data be available start date provided 01-01-2027 and end date provided 31-12-2031?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Sciatica is a clinical condition that is classically characterized by a sense of excruciating pain and paraesthesia along the course of the sciatic nerve, with a serious impact on the quality of life of those affected. Sciatica is estimated to occur in about 30% of LBP episodes, with an annual incidence of 1% to 5%. Homeopathy is a frequently used therapy to treat sciatic pain; however, the research evidence is limited. This 3-month, double-blind, randomized, placebo-controlled trial is aimed at evaluating the efficacy of homeopathic medicines in the treatment of sciatica pain in 72 adults. The primary outcome measure is RMPDQ; the secondary outcomes are SF-MPQ, OLBPDQ, and MYMOP-2 questionnaires, all measured at baseline and every month, up to 3 months. Comparative analysis will be carried out to detect group differences. Results will be published in scientific journals. 
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