| CTRI Number |
CTRI/2021/02/031477 [Registered on: 23/02/2021] Trial Registered Prospectively |
| Last Modified On: |
23/02/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Homeopathic treatment of sciatica pain |
|
Scientific Title of Study
|
Double-blind, randomized, placebo-controlled, feasibility trial of individualized
homeopathic medicines in sciatica pain |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1264-1497 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pulakendu Bhattacharya |
| Designation |
Lecturer |
| Affiliation |
D. N. De Homoeopathic Medical College and Hospital |
| Address |
Research OPD, Room no. 12, 12, Gobinda Khatick Road, Tangra, Kolkata 700046
Kolkata
WEST BENGAL
700046
India |
| Phone |
8442992147 |
| Fax |
|
| Email |
drpulakendu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Shyamal Kumar Mukherjee |
| Designation |
Principal and Administrator |
| Affiliation |
D. N. De Homoeopathic Medical College and Hospital |
| Address |
Principals Chamber, Administrative Division, 12, Gobinda Khatick Road, Kolkata, WEST BENGAL
Kolkata
WEST BENGAL
700046
India |
| Phone |
9831113383 |
| Fax |
|
| Email |
shyamalmukhergee@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Irfan Mondal |
| Designation |
3rd BHMS undergraduate student |
| Affiliation |
D. N. De Homoeopathic Medical College and Hospital |
| Address |
Research OPD, room no. 12, 12, Gobinda Khatick Road, Kolkata, WEST BENGAL
Kolkata
WEST BENGAL
700046
India |
| Phone |
9123712004 |
| Fax |
|
| Email |
irfanmondal9533@gmail.com |
|
|
Source of Monetary or Material Support
|
| D N De Homoeopathic Medical College and Hospital |
|
|
Primary Sponsor
|
| Name |
D N De Homoeopathic Medical College and Hospital |
| Address |
12, Gobinda Khatick Road, Tangra, Kolkata, West Bengal 700046 |
| 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 |
| Pulakendu Bhattacharya |
D. N. De Homoeopathic Medical College and Hospital |
Research OPD, Room no. 12; 12, Gobinda Khatick Road, Tangra, Kolkata, West Bengal 700046
Kolkata
WEST BENGAL |
8442992147
drpulakendu@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 |
Homeopathic medicines in
centesimal potencies |
It is planned as administering indicated homeopathic remedies in centesimal potencies, as decided appropriate to the case or condition. In centesimal scale, 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
individual requirement of the
cases. All medicines will be procured from a Good Manufacturing Practice
(GMP)-certified firm. Route of administration of medicine: Oral. General advices will be given for posture maintenance, hot fomentation and spinal extensor exercises. Duration of therapy: 2 months. |
| Comparator Agent |
Placebo |
Placebo, identical in appearance with and indistinguishable from
the medicine. Each dose of
placebo shall consist of 4
globules (no. 30) of cane sugar, moistened with rectified spirit, to be taken orally on clean tongue with empty stomach; dosage and repetition depending upon
the individual requirement of the cases. All sundry items will be procured from a Good Manufacturing Practice (GMP)-certified firm. Route of administration: Oral. General advices will be given for posture maintenance, hot fomentation and spinal extensor exercises. Duration of therapy: 2 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of either sex
2. Age 18-65 years
3. Patients experiencing low back pain radiating to lower limb (unilateral or bilateral) since 3 months or more (2018/19 ICD-10-CM diagnosis code
M54.31); confirmed by straight leg raising test.
4. Patients who are literate and capable of filling the questionnaire and providing
informed consent. |
|
| ExclusionCriteria |
| Details |
1. Patients suffering from uncontrolled systemic diseases or infections; e.g. diabetes mellitus, cardiovascular diseases, thyroid diseases, etc.
2. Patients having history of surgery to the lower back
3. Patients suffering from 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 to enrolment in the study
5. Spinal corticosteroid injection within 6 months
6. Diagnosed cases of unstable psychiatric illness
7. Pregnant, lactating and puerperial women
8. Self-reported immune-compromised state
9. Substance abuse and/or dependence |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The Roland Morris pain and disability questionnaire (RMPDQ) |
At baseline and after 2 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| McGill pain questionnaire (MPQ) |
At baseline and after 2 months |
| Oswestry LBP questionnaire |
At baseline and after 2 months |
|
|
Target Sample Size
|
Total Sample Size="42"
Sample Size from India="42"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
24/02/2021 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
None, to be published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Data are available indefinitely at (Link to be included www.dndeofficial.org/).
- For how long will this data be available start date provided 01-12-2021 and end date provided 30-11-2026?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Sciatica is a debilitating condition in which the patient experiences pain and/or paresthesia in the distribution of the sciatic nerve or associated lumbo-sacral nerve root. Sciatica is a relatively common condition with a lifetime incidence varying from 13-40%. The different treatment methods are bed rest (trade-off), analgesics or NSAIDS, acupuncture, epidural steroid injections, spinal manipulation, traction therapy, physical therapy, behavioral treatment, surgical intervention etc. with various results. There are number of studies for the treatment of LBP in homeopathy, including the cases of sciatica pain. But, till date, there is no controlled trial of individualized homeopathy in sciatica pain. In this double-blind, randomized, placebo-controlled trial at D. N. De Homoeopathic Medical College and Hospital, 42 patients suffering from sciatica will be randomized to receive either individualized homeopathic medicines (verum; n=21) or identical-looking placebo (control; n=21). We aim to address the feasibility issues of conducting a definitive efficacy trial of individualized homeopathic medicines in the treatment of sciatica pain and disability, and to investigate whether there are any differences in outcomes between these two groups over 2 months of intervention. Roland Morris pain and disability questionnaire (RMPDQ), McGill pain questionnaire (MPQ), and Oswestry LBP questionnaire will be used as the primary and secondary outcome measures respectively. Feasibility issues will be checked and comparative analysis will be carried out to examine group differences, if any. Results will be published in scientific journals.
|