| CTRI Number |
CTRI/2024/11/077279 [Registered on: 25/11/2024] Trial Registered Prospectively |
| Last Modified On: |
19/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Homoeopathic treatment of sciatica pain |
|
Scientific Title of Study
|
Effectiveness of Individualized Homoeopathic Medicines in Pain and Health-Related Quality of life in Patients with Sciatica using Synthesis Repertory: A Single Group, Pre-Post Interventional 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 Soumitra Bose |
| Designation |
Post graduate trainee |
| Affiliation |
Mahesh Bhattacharyya Homoeopathic Medical College and Hospital |
| Address |
Department of Repertory
Dr.B.N. Chakraborty Sarani, Doomurjola, Howrah-711104, West Bengal
Haora
WEST BENGAL
711104
India |
| Phone |
9775514200 |
| Fax |
|
| Email |
bosesoumitra68@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Samit Dey |
| Designation |
Professor |
| Affiliation |
Mahesh Bhattacharyya Homoeopathic Medical College and Hospital |
| Address |
Department of Repertory
Dr.B.N. Chakraborty Sarani, Doomurjola, Howrah-711104, West Bengal
Haora
WEST BENGAL
711104
India |
| Phone |
9875371414 |
| Fax |
|
| Email |
dr.samit77@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Samit Dey |
| Designation |
Professor |
| Affiliation |
Mahesh Bhattacharyya Homoeopathic Medical College and Hospital |
| Address |
Department of Repertory
Dr.B.N. Chakraborty Sarani, Doomurjola, Howrah-711104, West Bengal
Haora
WEST BENGAL
711104
India |
| Phone |
9875371414 |
| Fax |
|
| Email |
dr.samit77@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mahesh Bhattacharyya Homoeopathic Medical College and
Hospital |
|
|
Primary Sponsor
|
| Name |
Dr Soumitra Bose |
| Address |
Department of Repertory, Dr.B.N. Chakraborty Sarani, Doomurjola, Howrah-711104, West Bengal |
| 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 Soumitra Bose |
Mahesh Bhattacharyya Homoeopathic Medical College and Hospital |
Department of Repertory
Dr.B.N. Chakraborty Sarani, Doomurjola, Howrah-711104, West Bengal
Haora
WEST BENGAL |
9775514200
bosesoumitra68@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Mahesh Bhattacharyya Homoeopathic Medical College and Hospital |
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 |
All patients enrolled in the study will receive individualized homoeopathic medicine.
Centesimal potencies will be used. All medicines procured are GMP-certified. Participants will receive dietary and lifestyle
advice to support overall health.
|
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients experiencing low back pain radiating to lower limb (unilateral or bilateral) since 3
months or more; confirmed by Straight leg raise (SLR) test.
Cases of sciatica with following symptoms: (1) Constant or intermittent pain anywhere in
the course of sciatic nerve.
(2) Sharp, Shooting pain anywhere in the course of sciatic nerve.
(3) Burning or tingling sensation anywhere in the course of sciatic nerve.
Patients of age group 18 – 65 years.
Person not taking any other medicines either Homoeopathic or other forms for the last 1
month for the same suffering.
|
|
| ExclusionCriteria |
| Details |
Patients suffering from uncontrolled endocrine disorders, cardiovascular
diseases and other uncontrolled or life-threatening illnesses affecting quality of
life or any organ failure.
Confirmed cases of spinal injury, disc prolapse, cases willing for or requiring
immediate surgical intervention or already underwent any major spinal or hip
surgery in last 6 months.
Spinal corticosteroid injection within 6 months.
Diagnosed psychological, personality, and neurological disorders such as
dementia, Alzheimer’s disease, and parkinsonism.
Chronic alcoholism and substance abuse.
Pregnancy and lactating ladies. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in the pain of sciatica measured using Numerical Pain Rating Scale (NPRS) |
Each patient will get follow-up for at least 3 months at the interval of 1 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Improvement in quality of life assessed using Oswestry Low Back Pain Disability
Questionnaire (OLBPDQ). |
Each patient will get follow-up for at least 3 months at the interval of 1 month |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
02/12/2024 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
INTRODUCTION: Hippocrates was, the first physician to use the term ‘sciatica’, deriving from the Greek ‘’ischios’’, hip. Sciatica (ME84.3 as per ICD-11) is commonly used to describe radiating leg pain. It is caused by inflammation or compression of the lumbosacral nerve roots (L4-S1) forming the sciatic nerve. A crucial function of the sciatic nerve is to provide direct motor activity to the hamstrings and lower extremity adductors, as well as indirect motor function to the anterior lower leg muscles, calf muscles, and select intrinsic foot muscles. Furthermore, its terminal branches indirectly contribute to sensation in the posterior and lateral lower leg and the plantar aspect of the foot. Importantly, sciatica predominantly arises from an inflammatory condition, leading to sciatic nerve irritation. Conversely, direct nerve compression results in more pronounced motor dysfunction, necessitating a thorough and prompt diagnostic evaluation if present. From a maximum incidence of 40%, the prevalence of sciatica varies greatly between research. Most instances occur in life’s fourth and fifth decades. In conservative treatment pain medications have uncertain benefits for sciatica and can have adverse effects, because of their role and use only very sparsely for a short period (weeks rather than months) and in the lowest possible dose for pain relief. Corticosteroids may improve symptoms for a short period (six weeks), as compared to a placebo. In Homeopathy, we do not treat based on the name of the disease, i.e. sciatica, but we treat the patients as a whole using constitutional medicines based on a summary of symptoms. These drugs reduce pain and limit disability. There have been many studies on sciatica in other areas, but very few works have been done in homoeopathy. This study presents cases clinically and radio-logically diagnosed as sciatica and their response to individualized homeopathic medicine in the context of pain via the Numerical Pain Rating Scale (NPRS) and changes the overall health-related quality of life by using the Oswestry Low Back Pain Disability Questionnaire (OLBPDQ) and with the help of the Synthesis repertory. |