| CTRI Number |
CTRI/2025/02/081478 [Registered on: 28/02/2025] Trial Registered Prospectively |
| Last Modified On: |
27/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to assess the usefulness of homoeopathic medicines for pain management in cases of sciatica |
|
Scientific Title of Study
|
A prospective interventional study to assess the effectiveness of medicines selected from Homoeopathic Medical Repertory by Robin Murphy for pain management in cases of sciatica |
| 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 Soumya Singh |
| Designation |
PG Scholar |
| Affiliation |
Dr M P K Homoeopathic Medical College Hospital And Research Centre |
| Address |
Department Of Repertory Dr M P K Homoeopathic Medical College Hospital And Research Centre A Constituent College Of Homoeopathy University Saipura Sanganer Jaipur Rajasthan
Jaipur RAJASTHAN 302029 India |
| Phone |
9532290770 |
| Fax |
|
| Email |
drsoumyasingh15@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Navita Sharma |
| Designation |
Assistant Professor |
| Affiliation |
Dr M P K Homoeopathic Medical College Hospital and Research Centre |
| Address |
Department Of Repertory Dr M P K Homoeopathic Medical College Hospital And Research Centre A Constituent College Of Homoeopathy University Saipura Sanganer Jaipur Rajasthan
Jaipur RAJASTHAN 302029 India |
| Phone |
7073469321 |
| Fax |
|
| Email |
navitasharma0796@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Soumya Singh |
| Designation |
PG Scholar |
| Affiliation |
Dr M P K Homoeopathic Medical College Hospital and Research Centre |
| Address |
Department Of Repertory Dr M P K Homoeopathic Medical College Hospital And Research Centre A Constituent College Of Homoeopathy University Saipura Sanganer Jaipur Rajasthan
Jaipur RAJASTHAN 302029 India |
| Phone |
9532290770 |
| Fax |
|
| Email |
drsoumyasingh15@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Repertory Dr Girendra Pal Homoeopathic Hospital and Research Centre Collegiate Hospital of Dr M P K Homoeopathic Medical College Hospital And Research Centre A Constituent College of Homoeopathy University Saipura Sanganer Jaipur Rajasthan 302029 |
|
|
Primary Sponsor
|
| Name |
Dr M P K Homoeopathic Medical College Hospital And Research Centre |
| Address |
10 11 12 Ward No 36 Saipura Sanganer Jaipur Rajasthan 302029 |
| Type of Sponsor |
Private 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 Soumya Singh |
Dr Girendra Pal Homoeopathic Hospital and Research Centre |
Department of Repertory OPD Room No 3 Dr M P K Homoeopathic Medical College Hospital And Research Centre A Constituent College Of Homoeopathy University 10 11 12 Ward No 36 Saipura Sanganer Jaipur Rajasthan Jaipur RAJASTHAN |
9532290770
drsoumyasingh15@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Homoeopathy University Jaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M543||Sciatica, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualised homoeopathic medicine selected with help of Homoeopathic Medical Repertory by Robin Murphy. |
Homoeopathic medicine shall be given orally in any potency 6c, 30c, 200c, 1M, 10M, 50M, CM as per the requirement of the case and Hahnemanns guidelines mentioned in Organon Of Medicine in form of globules of 60 number. Dose and repetition as per need of the case, reassessment at the end of 3 months. |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients between the ages of 18 years to 60 years diagnosed with positive SLR test and diagnosed cases of sciatica according to ICD-10 criteria M54.3 |
|
| ExclusionCriteria |
| Details |
Patients with advanced conditions such as bladder involvement, degeneration of spine, spinal/ intra- spinal tumors, lumbar canal stenosis, deformity of the spinal column, etc.
Any lesion of the sciatic nerve as per ICD-10 G57.
Any lesion due to intervertebral disc disorder as per ICD-10 M51.1.
Patients suffering from HIV, Hepatitis B/C, malignancy, etc.
Pregnant women and lactating mothers.
Patients taking other treatments for sciatica.
Cases requiring surgical intervention and emergency treatment.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Based on the scores obtained (pre-treatment and post-treatment) from the Numeric Pain Rating Scale (NPRS) and SF-12 scales. |
Pre-treatment scores will be taken at the baseline of the treatment, and post-treatment scores will be assessed at the end of 12 weeks using the Numeric Pain Rating Scale (NPRS) and SF-12 scales. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The individualized homoeopathic medicine selected with aid of Homoeopathic Medical Repertory by Robin Murphy will be effective in managing the pain in cases of sciatica.
It is expected that Homoeopathic medicine will reduce the intensity of pain thus improving the quality of life of the patient. |
12 months |
|
|
Target Sample Size
|
Total Sample Size="85" Sample Size from India="85"
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 3 |
|
Date of First Enrollment (India)
|
10/03/2025 |
| 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="0" 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
|
Aim- To ascertain the effectiveness of homoeopathic medicine with the help of Homoeopathic Medical Repertory by Robin Murphy in pain management in cases of sciatica.Objective-To assess the effectiveness of homoeopathic medicines
selected with the help of Homeopathic Medical Repertory by Robin Murphy in
management of sciatic pain through evaluation of pre and post value of NPRS
score.To assess the effectiveness of homoeopathic medicines
selected with the help of Homeopathic Medical Repertory by Robin Murphy in
management of sciatic pain through evaluation of pre and post value of SF 12
score. |