| CTRI Number |
CTRI/2024/05/067743 [Registered on: 21/05/2024] Trial Registered Prospectively |
| Last Modified On: |
20/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Treatment of Sciatica with Homoeopathic medicine |
|
Scientific Title of Study
|
A prospective interventional study on Sciatica with individualized homoeopathic medicine |
| 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 Khirod Bisoi |
| Designation |
PGT Dept of Practice of Medicine |
| Affiliation |
RBTS Government Homoeopathic Medical College and Hospital |
| Address |
Room no 03 PG Building Academic Block RBTS Govt Homoeopathic Medical College And Hospital
Muzaffarpur Bihar
Muzaffarpur
BIHAR
842002
India |
| Phone |
9439293747 |
| Fax |
|
| Email |
khirodbisoi.689@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kajal |
| Designation |
Assistant Professor Dept of Practice of Medicine |
| Affiliation |
RBTS Govt Homoeopathic Medical College And Hospital |
| Address |
Room no 03 PG Building Academic Block RBTS Govt Homoeopathic Medical College And Hospital
Muzaffarpur Bihar
Muzaffarpur
BIHAR
842002
India |
| Phone |
7979096206 |
| Fax |
|
| Email |
kajalrbts04@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kajal |
| Designation |
Assistant Professor Dept of Practice of Medicine |
| Affiliation |
RBTS Govt Homoeopathic Medical College And Hospital |
| Address |
Room no 03 PG Building Academic Block RBTS Govt Homoeopathic Medical College And Hospital
Muzaffarpur Bihar
Muzaffarpur
BIHAR
842002
India |
| Phone |
7979096206 |
| Fax |
|
| Email |
kajalrbts04@gmail.com |
|
|
Source of Monetary or Material Support
|
| RBTS GOVT HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL MUZAFFARPUR BIHAR INDIA 842002 |
|
|
Primary Sponsor
|
| Name |
RBTS Govt Homoeopathic Medical College And Hospital |
| Address |
Muzaffarpur Bihar India 842002 |
| 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 Kajal |
RBTS Govt Homoeopathic Medical College And Hospital |
OPD 1 OPD 3 OPD 4 OPD 5 OPD 6 and IPD Hospital Block RBTS Govt Homoeopathic Medical College And Hospital
Muzaffarpur
BIHAR |
7979096206
kajalrbts04@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics comittee RBTS Govt Homoeopathic Medical College And Hospital Muzaffarpur Bihar |
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 |
INDIVIDUALIZED HOMOEOPATHIC MEDICINE |
SELECTED MEDICINE WILL BE GIVEN IN 30 200 1M POTENCY AND FOLLOW-UP SHOULD BE DONE AT 15 DAYS INTERVAL FOR ABOUT 1 TO 3 MONTHS |
| Comparator Agent |
NOT APPLICABLE |
NIL |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients willing to participate in the study
Patients of the age group between 30 to 60 years
Patients of both sexes all religions and from different socioeconomic status
Self-reported and pre-diagnosed cases of sciatica.
Patients with the symptomatology of sciatica showing Positive straight leg raising
test |
|
| ExclusionCriteria |
| Details |
Age below 30 years and above 60years
Diagnosed cases of systemic diseases immunocompromised states psychiatric
illness or other uncontrolled or life-threatening illness affecting quality of life or
any organ failure.
Known cases of fractured vertebrae dislocation of vertebrae tuberculosis of
spine neoplasm of the spine or any other congenital defects.
Pregnancy and lactation.
Substance abuse or dependence.
Those patients who have not given their consent
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
constitutional homoeopathic medicine when prepared and
administered according to the homoeopathic principles acts curatively, relieving
the sciatic pain gradually thereby preventing the recurrence and
complications |
4 WEEKS TO 12 WEEKS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To improve and assess the quality of life in sciatica using use a scoring system |
1 to 3 months |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 4 |
|
Date of First Enrollment (India)
|
07/06/2024 |
| 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="0"
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
|
Sciatica usually describes a symptom -shooting pain along the cutaneous distribution of sciatic nerve pathway - rather than specific condition, illness or disease. Sciatica pain usually begins in the gluteal region, and radiates along the back of the thigh, and the lateral side of leg, to the dorsum of the foot. The diagnosis of sciatica is made mainly on a clinical basis. It is performed by the Straight leg raise (SLR) test. The homoeopathic medicine seems to be efficacious in the treatment of sciatica as it aims at the constitution of the patient which predisposes to sciatica. Homoeopathy is fully equipped to treat neuralgic pains, including sciatica in the holistic way. |