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CTRI Number  CTRI/2022/04/041878 [Registered on: 13/04/2022] Trial Registered Prospectively
Last Modified On: 27/06/2024
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 low back pain 
Scientific Title of Study   Repertorial approach in homoeopathic treatment of chronic low back pain: Double-blind, randomized, placebo-controlled pilot trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sagarika Muduli 
Designation  Postgraduate Trainee 
Affiliation  D N De Homoeopathic Medical College & Hospital 
Address  Dept. of Repertory, 12, Gobinda Khatick Road, Tangra

Kolkata
WEST BENGAL
700046
India 
Phone  9875424544  
Fax    
Email  sagarika.muduli4@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Sanjib Sarkar 
Designation  Lecturer 
Affiliation  D N De Homoeopathic Medical College & Hospital 
Address  Dept. of Anatomy, 12, Gobinda Khatick Road, Tangra

Kolkata
WEST BENGAL
700046
India 
Phone  9903701819  
Fax    
Email  sanjibsarkar1102@gmail.com  
 
Details of Contact Person
Public Query  
Name  Sanjib Sarkar 
Designation  Lecturer 
Affiliation  D N De Homoeopathic Medical College & Hospital 
Address  Dept. of Anatomy, 12, Gobinda Khatick Road, Tangra


WEST BENGAL
700046
India 
Phone  9903701819  
Fax    
Email  sanjibsarkar1102@gmail.com  
 
Source of Monetary or Material Support  
D. N. De Homoeopathic Medical College and Hospital, Govt. of West Bengal, 12, Gobinda Khatick Road, Tangra, Kolkata 700046, West Bengal 
 
Primary Sponsor  
Name  D N De Homoeopathic Medical College Hospital 
Address  12, Gobinda Khatick Road, Tangra, Kolkata 700046, West Bengal 
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 Sagarika Muduli  D N De Homoeopathic Medical College and Hospital, Govt. of West Bengal  Dept. of Repertory, OPD room no. PG-3 and 10 (Research OPD), 12, Gobinda Khatick Road, Tangra, Kolkata 700046
Kolkata
WEST BENGAL 		 9875424544

sagarika.muduli4@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee of D. N. De Homoeopathic Medical College and Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M545||Low back pain,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Identical-looking placebos  This arm will receive placebos, identical to verum. Each dose of placebo shall consist of 4 globules (no. 40) of cane sugar, to be taken orally on clean tongue in empty stomach; dosage and repetition depending upon the individual requirement of the cases. Both medicines and placebos will be re-packed in identical glass bottles and labelled with code, name of medicine, potency, and will be dispensed according to the random number list. All the enrolled patients will receive standardized management guidelines for yoga, spinal exercises, fomentations, lumbar braces and ergonomic adjustments. Duration of therapy: 4 months. 
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 4 globules (no. 40) 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. 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 and RADAR software when required with due consultation of Materia Medica and due consensus among three homeopaths. All medicines will be procured from a Good Manufacturing Practice (GMP)-certified firm. All the enrolled patients will receive standardized management guidelines for yoga, spinal exercises, fomentations, lumbar braces and ergonomic adjustments. Duration of therapy: 4 months. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Patient suffering from low back pain for 3 months or more
2. Patients with radiological diagnosis indicating different causes of low back pain with mild to moderate degenerative radiological changes
3. Patients of age 18 to 65 years.
4. Patients of either sex.
5. Literate patients, able to read and write in Bengali, Hindi and/or English.
6. Patients giving written informed consent to participate 
 
ExclusionCriteria 
Details  1. Patients with severe degenerative changes in radiological findings like spinal abnormalities, ankylosing spondylitis, epidural abscess, congenital abnormalities etc.
2. Patients with history of spinal surgery or requiring/willing for the same
3. Uncontrolled hypertension, diabetes, cancer, any other systemic illness, or any vital organ failure
4. Vulnerable population - unconscious, ambulatory, too sick for consultation, differently abled, terminally or critically ill patients, mentally incompetent people.
5. Patient with psychiatric illness and under homeopathic treatment for any chronic disease within last 6 months
6. Self-reported immune-compromised state
7. Patient under tobacco chewing and/or smoking, alcoholism and/or any other form(s) of substance abuse and/or dependence
8. Pregnant and puerperal women and lactating mothers 
 
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 
Oswestry low back pain and disability questionnaire (ODQ)  Baseline, every month, up to 4 months 
 
Secondary Outcome  
Outcome  TimePoints 
Roland Morris pain and disability questionnaire (RMPDQ)  Baseline, every month, up to 4 months 
McGill pain questionnaire short form (SF-MPQ)  Baseline, every month, up to 4 months 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   18/04/2022 
Date of Study Completion (India) 10/12/2022 
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 
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 - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  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 [sagarika.muduli4@gmail.com].

  6. For how long will this data be available start date provided 01-11-2023 and end date provided 31-10-2028?
    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
Modification(s)  

Low back pain (LBP), the most common musculoskeletal complaint and a leading cause of work disability. A double-blind, randomized, placebo-controlled trial on 60 participants was carried out at D. N. De Homoeopathic Medical College and Hospital to identify the differences between individualized homeopathic medicines and identical-looking placebos in treatment of low back pain after 4 months of intervention. Participants were randomized into either verum (n=30) or placebos (n=30) in the mutual context of concomitant care, e.g., hot fomentations, spinal extensor exercises, etc. Primary outcome measure was Oswestry low back pain and disability questionnaire; secondary outcome measures were Roland-Morris pain and disability questionnaire and Mc Gill pain questionnaire short form; all measured at baseline, and every month, up to 4 months. Comparative analysis was carried out to detect group differences. Group differences achieved significance or near significance in all the specified outcomes – ODQ score (P = 0.042), RMPDQ score (P = 0.092), and SF-MPQ total score (P = 0.012). Rhus toxicodendron, Bryonia alba, Hypericum perforatum and Nux vomica were the most frequently prescribed medicines. Thus, homeopathic medicines worked significantly better than placebos in reducing chronic low back pain. Independent replications are warranted to substantiate the findings.

 
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