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CTRI Number  CTRI/2024/04/065166 [Registered on: 03/04/2024] Trial Registered Prospectively
Last Modified On: 03/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Usage of homoeopathic medicines in chronic low backache 
Scientific Title of Study   Effectiveness of Homoeopathic Medicines in Chronic Low backache selected using Boenninghausen’s Doctrine of Complete symptom vis-à-vis Anamnesis through Gestalt Philosophy Double Armed Open Label Clinical Randomized 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  Dr Kaushiki Krishna 
Designation  PGT Trainee 
Affiliation  National Institute Of Homoeopathy 
Address  OPD Room No 10, Department of Repertory, National Institute of Homoeopathy, Block GE, Sector III, Salt Lake, Kolkata Kolkata

North Twentyfour Parganas
WEST BENGAL
700106
India 
Phone  8210131636  
Fax    
Email  kaushikikrishna7@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Birendra Prasad Srivastava 
Designation  Professor 
Affiliation  National Institute Of Homoeopathy 
Address  OPD Room No 10, Department of Repertory,National Institute Of Homoeopathy, GE Block, Sector III, Saltlake, Kolkata. Kolkata

North Twentyfour Parganas
WEST BENGAL
700106
India 
Phone  7003178867  
Fax    
Email  dr.srivastava61@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Birendra Prasad Srivastava 
Designation  Professor 
Affiliation  National Institute Of Homoeopathy 
Address  OPD Room No 10, Department of Repertory,National Institute Of Homoeopathy, GE Block, Sector III, Saltlake, Kolkata. Kolkata


WEST BENGAL
700106
India 
Phone  7003178867  
Fax    
Email  dr.srivastava61@gmail.com  
 
Source of Monetary or Material Support  
National Institute Of Homoeopathy, Block GE, Sector III, Salt Lake, Kolkata, West Bengal,700106, India. 
 
Primary Sponsor  
Name  National Institute Of Homoeopathy 
Address  National Institute Of Homoeopathy, Block GE, Sector III, Salt Lake, Kolkata, West Bengal,700106, India. 
Type of Sponsor  Government medical college 
 
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 Kaushiki Krishna  National Institute Of Homoeopathy  OPD No 10, Department of Repertory, Block GE, Sector III, Salt Lake Kolkata
North Twentyfour Parganas
WEST BENGAL 
8210131636

kaushikikrishna7@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
National Institute Of Homoeopathy  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  Individualised homoeopathic medicine selected on the basis of Boenninghausen’s principles.  Intervention is planned as administering indicated homoeopathic medicines (on the basis of Boenninhausens principles) as decided appropriate to the case or condition; dosage and repetition depending upon the individual requirement of the cases. 
Intervention  Individualised homoeopathic medicine selected on the basis of Gestalt philosophy.  Intervention is planned as administering indicated homoeopathic medicines (selected on the basis of Gestalt philosophy) as decided appropriate to the case or condition; dosage and repetition depending upon the individual requirement of the cases. Follow up will be done monthly till 6 months from the baseline.  
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Patients suffering from low back pain for 6-12 weeks.
2. Patients of both genders and all religions.
3. Patients willing to give informed consent to participate in the study.
 
 
ExclusionCriteria 
Details  1. Chronic referred LBP due to non-spinal organs
2. Currently receiving homoeopathic treatment for chronic condition(s).
3. Uncontrolled, unevaluated, and/or complicated diabetes mellitus, hypertension, and other
comorbities; cases with other serious systemic unevaluated or uncontrolled diseases affecting
quality of life or on other treatment therapies; psychiatric illness.
4. Substance abuse and/or dependence.
5. Pregnant and lactating women
6. Self-reported immune-compromised state
7. Patients unwilling to give consent for taking part in the study and regular follow ups. 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Oswestry Disability Index (ODI)  Oswestry Disability Index (ODI) 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="62"
Sample Size from India="62" 
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)   15/04/2024 
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)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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  

Low back pain describes pain between the lower edge of the ribs and the buttock. Chronic low back pain (CLBP) is defined as pain that continues for 12 weeks or longer, even after an initial injury or underlying cause of acute low back pain has been treated. Gestalt philosophy emphasizes that the meaning of something is determined by its context, not by its individual components. This resonates with Boenninghausen’s belief that symptoms are not isolated entities but rather expressions of a deeper underlying imbalance in the patient’s vital force. Both approaches move away from rigid, one-size-fits-all solutions and instead emphasize the importance of individualization in understanding and treating illness.

This study aims at finding any relationship between Gestalt philosophy and Boenninhausen’s principles.

It is an open randomized two parallel arm clinical study is being taken up at the OPD of National institute of Homoeopathy, Kolkata, West Bengal.Samples will be selected following preliminary and detailed screening using specified selection criteria.

Inclusion and exclusion criterias will be strictly followed.

Sixty two patients suffering from Chronic Low Back pain will be randomised either of the two trial arms in 1:1 ratio on the basis of odd or even, according to sequential order of their enrolment. 

Odd enrolment number will receive the homoeopathic prescription as per Boenninghausen’s principle and even enrolment number will receive prescription as per boennihausen’s principle. 

Outcome data, using Oswestry Disability Index will be recorded at baseline and at 6 month interval. Group differences (independent observations) will be tested at baseline (to check comparability) and after 6 months by statistical tests as appropriate.


 
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