| CTRI Number |
CTRI/2025/02/081228 [Registered on: 24/02/2025] Trial Registered Prospectively |
| Last Modified On: |
22/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Role of homoeopathic medicines in the treatment of low back pain. |
|
Scientific Title of Study
|
Role of individualized homoeopathic medicines in the treatment of low back pain in sedentary lifestyle an open label prospective single arm pre and post clinical 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 |
Roshni ratre |
| Designation |
Post graduate trainee |
| Affiliation |
National institute of homoeopathy |
| Address |
National institute of homoeopathy block GE sector 3 salt lake kolkata west bengal room no.14 Department of organon of medicine
North Twentyfour Parganas
WEST BENGAL
700106
India |
| Phone |
6263519411 |
| Fax |
|
| Email |
roshniratre85@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Roshni ratre |
| Designation |
Post graduate trainee |
| Affiliation |
National institute of homoeopathy |
| Address |
National institute of homoeopathy block GE sector 3 salt lake kolkata west bengal room no.14 Department of organon of medicine
North Twentyfour Parganas
WEST BENGAL
700106
India |
| Phone |
6263519411 |
| Fax |
|
| Email |
roshniratre85@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr Subhas Singh |
| Designation |
Professor |
| Affiliation |
National institute of homoeopathy |
| Address |
National institute of homoeopathy block GE sector 3 salt lake kolkata west bengal room no.14 Department of organon of medicine
National institute of homoeopathy block GE sector 3 salt lake kolkata west bengal
North Twentyfour Parganas
WEST BENGAL
700106
India |
| Phone |
9830644223 |
| Fax |
|
| Email |
drssubhas@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Self Dr Roshni ratre |
| Address |
National institute of homoeopathy block GE sector 3 salt lake kolkata west bengal room no.14 Department of organon of medicine
|
| Type of Sponsor |
Other [Self Dr Roshni ratre] |
|
|
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 |
| DrRoshni Ratre |
National Institute of Homoeopathy Hospital |
National institute of homoeopathy block GE sector 3 salt lake kolkata west bengal room no.14 Department of organon of medicine
North Twentyfour Parganas
WEST BENGAL |
06263519411
roshniratre85@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: M489||Spondylopathy, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualized homoeopathic medicine |
Individualized homoeopathic medicine given for 6 months |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed and stable patient suffering from low back pain with history sedentary lifestyle.
Patient fulfilling the criteria of sedentary lifestyle according to short version of the International Physical Activity Questionnaire (IPAQ).
Age 18-65 years.
Both sexes.
Ability to read or understand Bengali or Hindi or English.
Providing written informed consents
|
|
| ExclusionCriteria |
| Details |
Cases require immediate surgical intervention or life support measures.
Cases suffering from uncontrolled systemic illness or life-threatening infections.
Unwilling to take part and not giving consent to join the study.
Diagnosed cases of unstable mental or psychiatric illness or other uncontrolled or life-threatening illness affecting quality of life or any organ failure.
Pregnant women and lactating mothers
Substance abuse and/or dependence.
Self-reported immune-compromised state, and
Undergoing homoeopathic treatment for any chronic disease within last 6 months.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The outcome assessment of the patients shall be calculated as per changes in Standard scoring systems Oswestry low back pain disability questionnaire and The STarT Back Screening score level . |
At baseline and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
07/03/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
07/03/2025 |
| 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 Yet Recruiting |
| 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
|
Ø With the research question of can individualized homeopathic medicine demonstrate significant improvement in patients suffering from low back pain in sedentary lifestyle. Participants fulfilling the inclusion & exclusion criteria shall be included in the study. with the aim to establish the role of individualized homoeopathic medicines in patient suffering from low back pain in sedentary lifestyle. with the primary objectives to determine the changes in the Oswestry low back pain disability questionnaire (ODQ) after 6 months individualized homoeopathic medicine and to find out the changes in the quality of life of patients with low back pain using STarT Back Screening Tool after 6 months individualized treatment.Study period is 18 months including 6 months of follow up of each case (at least 4 months).the calculated sample size is 45 considering 10% drop out, the target sample size is 50. |