| CTRI Number |
CTRI/2025/07/091202 [Registered on: 18/07/2025] Trial Registered Prospectively |
| Last Modified On: |
12/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Role of Homoeopathic Remedies on Sciatica Pain |
|
Scientific Title of Study
|
Effectiveness of Individualised Homoeopathic Remedies in the Management of Pain of Sciatica on the basis of Experimental 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 Shubhangi Sukumar Magdum |
| Designation |
Phd Scholar |
| Affiliation |
YMT Homoeopathic Medical College |
| Address |
Room No 01, Department of Homoeopathic Materia Medica, YMT Homoeopathic Medical College, Kharghar, Navi Mumbai
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9422582621 |
| Fax |
|
| Email |
shubhangimagdum.1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vinod Sawant |
| Designation |
Associate Professor |
| Affiliation |
YMT Homoeopathic Medical College |
| Address |
Room No 01, Department of Homoeopathic Materia Medica, YMT Homoeopathic Medical College, Kharghar, Navi Mumbai
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9082553082 |
| Fax |
|
| Email |
drvinodsawant@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shubhangi Sukumar Magdum |
| Designation |
Phd Scholar |
| Affiliation |
YMT Homoeopathic Medical College |
| Address |
Room no 01, Department of Homoeopathic Materia Medica, YMT Homoeopathic Medical College, Kharghar, Navi Mumbai
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9422582621 |
| Fax |
|
| Email |
shubhangimagdum.1@gmail.com |
|
|
Source of Monetary or Material Support
|
| YMT Homoeopathic Medical College Sector 4 Kharghar Navi Mumbai 410210 Maharashtra India |
|
|
Primary Sponsor
|
| Name |
YMT Homoeopathic Medical College |
| Address |
Sector 4 Kharghar Navi Mumbai 410210 Maharashtra India |
| 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 Shubhangi Magdum |
YMT Homoeopathic Hospital |
Orthoepedic OPD No 1
YMT Homoeopathic Hospital
Kharghar Navi Mumbai
Raigarh
MAHARASHTRA |
9422582621
shubhangimagdum.1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
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 |
Indicated Homoeopathic Remedy |
Remedy will be given in 30/200/1M potency in 40 number globules 3 times a day for 15 days for 3 months |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1 Positive Slow leg rise test
2 Patients with Chronic Backpain, Lumbar Spondylosis, degenerative spine changes
3 Co- morbidities like diabetes and hypertension
|
|
| ExclusionCriteria |
| Details |
1 Pregnant females
2 lactating females
3 Patients with congenital causes like spina bifida, kyphoscoliosis and tethered spinal cord
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pain of sciatica will be assessed using visual analogue scale and the symptoms of patient |
at baseline, 4 weeks and 8 weeks |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
21/07/2025 |
| 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="0"
Months="3"
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
|
The feeling of unbearable pain
in the back or buttocks, that runs down the thighs and which extends to the
feet is the first sign of Sciatica. It is also associated with numbness and
tingling sensation in the legs with weakness.
Usually, it starts from the back
due to the compression of nerve roots from the spinal cord which continues to
the hips and buttocks and then to the feet. It is more common in men than
women.
It mostly affects people of
age group 40-50 and lasts up to six or seven weeks. Sometimes it persists for a
long duration.
The fact is that it is not a
disorder by itself but a symptom of pain in the pathway of the sciatic nerve.
It is typically a one sided complaint but gradually it might affect both the
sides.
Painkillers may provide for temporary
relief but the homoeopathic remedies for sciatica treat the problem from
the root cause and provide long term relief.
|