| CTRI Number |
CTRI/2023/06/054046 [Registered on: 16/06/2023] Trial Registered Prospectively |
| Last Modified On: |
16/06/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Homeopathy
Other (Specify) [Treatment using homoeopathic medicines ] |
| Study Design |
Other |
|
Public Title of Study
|
Treatment of Sciatica pain with homoeopathy |
|
Scientific Title of Study
|
A comparative study of centesimal potency & fifty millesimal potency in the treatment of sciatica pain in adults-an open label parallel arm pilot study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prof Dr Mihir Kanti Biswas |
| Designation |
HOD, DEPT OF MATERIA MEDICA |
| Affiliation |
Mahesh bhattacharya homoeopathic medical college and hospital |
| Address |
Mahesh bhattacharya homoeopathic medical college and hospital
Dr B.K Chakraborty Sarani(Drainage canal road) Dumoorjala Howrah
Haora
WEST BENGAL
711104
India |
| Phone |
9051236301 |
| Fax |
|
| Email |
drmkb33@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Madhusree Dutta |
| Designation |
PG SCHOLAR PART I |
| Affiliation |
West Bengal University of Health Sciences |
| Address |
Mahesh bhattacharya homoeopathic medical college and hospital
Dr B.K Chakraborty Sarani(Drainage canal road) Dumoorjala Howrah
Haora
WEST BENGAL
711104
India |
| Phone |
08777486871 |
| Fax |
|
| Email |
madhusreedutta2811@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Baishakhi Ghosh |
| Designation |
Lecturer |
| Affiliation |
Mahesh bhattacharya homoeopathic medical college and hospital |
| Address |
Mahesh bhattacharya homoeopathic medical college and hospital
Dr B.K Chakraborty Sarani(Drainage canal road) Dumoorjala Howrah
Haora
WEST BENGAL
711104
India |
| Phone |
08442992146 |
| Fax |
|
| Email |
drbaishakhibhatt@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mahesh bhattacharya homoeopathic medical college and hospital. |
|
|
Primary Sponsor
|
| Name |
Mahesh Bhattacharya Homoeopathic Medical College and Hospital |
| Address |
Dr B.N Chakraborty Sarani (Drainage Canal Road) Dumurjola, Howrah |
| 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 Mihir Kanti Biswas |
Mahesh Bhattacharya Homoeopathic Medical College and Hospital |
Department of Homoeopathic materia medica, OPD no. - 4,9 and 11
Mahesh Bhattacharya Homoeopathic Medical College and Hospital.
Dr B.N. Chakraborty Sarani (Drainage Canal Road) Dumurjola, Howrah - 711104
Haora
WEST BENGAL |
9051236301
drmkb33@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institution ethics 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 |
| Comparator Agent |
Individualised homoeopathic medicines in centesimal potencies |
This arm will receive individualised homoeopathic medicines in centisimal potencies. Each dose shall consist of 4 globules (no. 30) of cane sugar, medicated with the indicated medicine (preserved in 90% v/v ethanol) to be taken orally on clean tongue with empty stomach;dosage and repetition depending upon the requirement of the cases. All medicines will be procured from a Good Manufacturing Practice (GMP) certified firm. All patients will be given general advices on posture maintenance,applying hot fomentation to back, use of firm bed, spinal extensor exercises, and avoiding lifting heavy weights. Route of administration of medicine: Oral. Duration of therapy:3 months. |
| Intervention |
Individualised homoeopathic medicines in fifty millesimal potencies |
Intervention is planned as administering indicated homoeopathic medicine in fifty millesimal potencies, as decided appropriate to the case or condition. The medicine is taken orally on clean tongue with empty stomach;dosage and repetition depending upon the individual requirement of the cases. All medicines will be procured from a Good Manufacturing Practice (GMP)-certified firm. All patients will be given general advices on posture maintenance, applying hot fomentation to back ,use of firm bed, spinal extensor exercises,and avoiding lifting heavy weights. Route of administration of medicine: Oral. Duration of therapy: 3 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients experiencing low back pain radiating to lower limbs (unilateral or bilateral) since 3 months or more ( 2018/19 ICD-20-CM diagnosis code M54.31); confirmed by straight leg raising test (SLR) test.
2.Both sexes.
3.Literate patients, must be able to read and write bengali and or English.
4.Patients providing written informed consent or a thumb print on the already written informed consent form |
|
| ExclusionCriteria |
| Details |
1.Patients suffering from uncontrolled diabetes mellitus, cardiovascular diseases, Thyroid disorders.
2.Patient having a history of surgery to the lower pain.
3.Patients who are already diagnosed with disc prolapse, psoriatic arthritis and gout, cases willing for or requiring immediate surgical intervention or already underwent any major spinal or hip surgery in last 6 months.
4.Patients who are undergoing treatment with NSAIDs during 6 weeks prior enrollment in the study.
5.Spinal corticosteroid injection within 6 months.
6.Diagnosed cases of unstable Psychiatric illness.
7.Pregnant and non-lactating women.
8.Self-reported immune-compromised state.
9.Undergoing any homoeopathic treatment within last 2 weeks.
Substance abuse and/or dependence. |
|
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Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Roland Morris Disability Questionnaire (RMDQ) |
At baseline, every month, upto 3 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Visual analog scale (VAS) |
At baseline, every month, upto 3 months. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
26/06/2023 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Sciatica pain is an extremely common clinical condition where the standard management involves epidural steroidal injections and long-term use of which is extremely harmful for the health of the patient. Inadequate number of studies and evidences in favour of homoeopathy compel patients to opt for the standard allopathic management but this obstinate pain can be very finely managed by homoeopathy without any known side effects. This is an area where homoeopathy can stand up and make a notice. This study attempts to verify and compare thee effectiveness of individualised homoeopathic medicines in centisimal potency and fifty millesimal potency in the treatment of sciatica pain in adults. The scales of potentisation is one of the fundamental concepts of homoeopathy and thus it deserves adequate emphasis. |