| 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
|
|
|
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
|
|
|
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. |