| CTRI Number |
CTRI/2023/08/056240 [Registered on: 08/08/2023] Trial Registered Prospectively |
| Last Modified On: |
07/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A study on Efficacy of Homoeopathic medicines in the management of Sciatica |
|
Scientific Title of Study
|
Efficacy of Homoeopathic medicines in the management of Sciatica assessed by the Numerical Rating Score -A Randomized Single Blind Placebo Controlled 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 Suman Chaudhary |
| Designation |
PhD Scholar and Associate Professor |
| Affiliation |
Smt A J Savla Homoeopathic Medical College and Research Institute |
| Address |
Room no 15 Smt S H Gardi Homoeopathic Hospital attached with Smt A J Savla Homoeopathic Medical College and Research Institute
Pushpanjali Building Near District session Court Pilaji Ganj Mehsana
Mahesana
GUJARAT
384001
India |
| Phone |
7984340457 |
| Fax |
|
| Email |
drsuman1989@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jyoti Sharma |
| Designation |
Assistant Professor and PhD Supervisor |
| Affiliation |
Dr M P K Homoeopathic medical College Hospital and Research Center |
| Address |
Dr M P K Homoeopathic medical College Hospital and Research Center
Homoeopathy University Plot no 10 11 12
Saipura Sanganer
Jaipur
Jaipur
RAJASTHAN
302029
India |
| Phone |
9785835468 |
| Fax |
|
| Email |
jyotisharmasky11@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Suman Chaudhary |
| Designation |
PhD Scholar and Associate Professor |
| Affiliation |
Smt A J Savla Homoeopathic Medical College and Research Institute |
| Address |
Room no 15 Smt S H Gardi Homoeopathic Hospital attached with Smt A J Savla Homoeopathic Medical College and Research Institute
Pushpanjali Building Near District session Court Pilaji Ganj Mehsana
Mahesana
GUJARAT
384001
India |
| Phone |
7984340457 |
| Fax |
|
| Email |
drsuman1989@gmail.com |
|
|
Source of Monetary or Material Support
|
| Smt A J Savla Homoeopathic Medical College and Research Institute
Pushpanjali Building Near District session Court Pilaji Ganj Mehsana 384001 Gujarat |
|
|
Primary Sponsor
|
| Name |
Dr Suman Chaudhary |
| Address |
Smt A J Savla Homoeopathic Medical College and Research Institute
Pushpanjali Building Near District session Court Pilaji Ganj Mehsana 384001 Gujarat
|
| Type of Sponsor |
Other [SELF ] |
|
|
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 Suman Chaudhary |
Smt S H Gardi Homoeopathic Hospital |
Research Department-OPD (Out Patient Department)
Room no 15
Ground floor
Pushpanjali Building Near District session Court Pilaji Ganj Mehsana
pincode 384001
Mahesana
GUJARAT |
7984340457
drsuman1989@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Homoeopathy University Institutional Ethical Committee Jaipur |
Approved |
| Smt S H Gardi Homoeopathic Hospital attached with Smt A J Savla Homoeopatjic college |
No Objection Certificate |
|
|
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 |
| Comparator Agent |
Identical Placebo |
Identical placebo shall be given (white globule no. 30 moisten with dispensing alcohol).
Dose repetition will be a similar pattern to medicine group and will be dispense in a Plastic vial.
Frequency as per need of case.
Route of administration is Oral.
Duration of therapy is up to six month as per need of case. |
| Intervention |
Individualized Homoeopathic Medicine |
Potency 30c, 200c, 1M as per need of case.
Dose as per need of case,
medicines will be dispensed in globule form no. 30 in vial Plastic.
Frequency as per need of case.
Route of administration is Oral.
Duration of therapy is up to six month as per need of case.
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) Both genders male and female
2) Patient who suffer from the sciatica more than eight week of duration Diagnosis of sciatica will be done according to ICD 10 diagnostic criteria M 51 54.3 54. 4 code for sciatica
3) Sciatica with common causes only as disc herniation stenosis etc confirmed with Magnetic resonance Imaging MRI
4) Pain Score NRS Numerical Rating Score more than 3
5) Age group 20 to 60 year
6) Patients willing to participate in the study and give written informed consent |
|
| ExclusionCriteria |
| Details |
1) Patient who had undergone surgery of spine region within 1 year
2)Patients who had received trans-foraminal epidural injection in 6 months
3)Patients with diagnosed major psychiatric illness or personality disorders
4)Patient taking other mode of treatment such as allopathic, ayurvedic, herbal, homoeopathic etc. for sciatica.
5)Pregnant women, Lactating women
6)Patient not able to fill the Revised Oswestry Disability Index (ODI) related questionnaire and Numerical Rating Score (NRS) |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pain of sciatica using Numerical Rating Score |
Data will be taken at baseline at three month & six month & will be compared to assess the efficacy of homoeopathic medicine in cases of Sciatica |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Impact of sciatica on the quality of life using Revised Oswestry Disability Index |
Score will be calculated at baseline at three month & six month after the homoeopathic treatment or placebo |
|
|
Target Sample Size
|
Total Sample Size="116"
Sample Size from India="116"
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)
|
16/08/2023 |
| 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) |
Open to Recruitment |
Publication Details
Modification(s)
|
1 Individualized homoeopathic treatment for sciatica A retrospective case series in journal International Archives of Integrated Medicine Vol 12 Issue 1 January 2025
2 Chronic sciatica treated with individualized homoeopathic medicine A case report in journal International Journal of Homoeopathic Sciences Vol 8 Issue 1 Part A 2024 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is a randomized single blind placebo controlled trail conducted in the India. Efficacy of Homoeopathic Medicines in the management of Sciatica will be studied. The Primary outcome measures will be pain of sciatica using the Numerical Rating Score the data will be taken at baseline, at three month and six month and will be compared to assess the efficacy of homoeopathic medicine in cases of Sciatica. The secondary outcome measures will be impact of sciatica, on the quality of life using Revised Oswestry Disability Index.Score will be calculated before at baseline, three month and six month after the homoeopathic treatment or placebo. |