| CTRI Number |
CTRI/2019/11/021918 [Registered on: 07/11/2019] Trial Registered Prospectively |
| Last Modified On: |
09/11/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Homeopathic medicines for low back pain |
|
Scientific Title of Study
|
Efficacy of individualized homeopathic medicines in treatment of lumbar spondylosis: Double-blind, randomized, placebo-controlled clinical trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1242-9021 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Akshaya Prakash |
| Designation |
Postgraduate Trainee |
| Affiliation |
National Institute of Homoeopathy |
| Address |
Dept. of Organon of Medicine and Homoeopathic Philosophy, OPD room no. 5 and 7, Block GE, Sector III, Salt Lake
Kolkata WEST BENGAL 700106 India |
| Phone |
8075760626 |
| Fax |
|
| Email |
akshayaprakash1989@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Nitai Chand Bhowmick |
| Designation |
Reader |
| Affiliation |
National Institute of Homoeopathy |
| Address |
Dept. of Organon of Medicine and Homoeopathic Philosophy, OPD room no. 7, Block GE, Sector III, Salt Lake
Kolkata WEST BENGAL 700106 India |
| Phone |
8001384666 |
| Fax |
|
| Email |
nitai.ch.bhowmik@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Nitai Chand Bhowmick |
| Designation |
Reader |
| Affiliation |
National Institute of Homoeopathy |
| Address |
Dept. of Organon of Medicine and Homoeopathic Philosophy, OPD room no. 7, Block GE, Sector III, Salt Lake
WEST BENGAL 700106 India |
| Phone |
8001384666 |
| Fax |
|
| Email |
nitai.ch.bhowmik@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Homoeopathy, Ministry of AYUSH, Govt. of India; Block GE, Sector III, Salt
Lake, Kolkata 700106, West Bengal, India |
|
|
Primary Sponsor
|
| Name |
National Institute of Homoeopathy |
| Address |
Block GE, Sector III, Salt Lake, Kolkata 700106, West Bengal, India |
| 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 |
| Akshaya Prakash |
National Institute of Homoeopathy |
Dept. of Organon of Medicine and Homoeopathic Philosophy, OPD room no. 5 and 7, Block GE, Sector III, Salt Lake Kolkata WEST BENGAL |
8075760626
akshayaprakash1989@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: M478||Other spondylosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualized homeopathic medicines in centesimal potencies |
Intervention is planned as administering indicated homeopathic medicines in centesimal potencies, as decided appropriate to the case or condition. In centesimal scale, each dose shall consist of 6-8 globules (no. 10) of cane sugar, medicated with a single drop of 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. Along with medicines, the intervention arm will receive standardized guidelines for mutual physiotherapy and spinal exercises. Duration of therapy: 3 months. |
| Comparator Agent |
Placebo, indistinguishable in appearance from verum |
Each dose of placebo shall
consist of 6-8 globules (no. 20) of cane sugar, to be taken orally on clean tongue with empty stomach; dosage and repetition depending upon the individual requirement of the cases. Patients will receive standardized guidelines for mutual physiotherapy and spinal exercises. Duration of therapy: 3 months. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with radiological diagnosis of lumbar spondylosis with mild to moderate degenerative radiological changes
2. Patients of age 18 to 65 years
3. Patients of both sexes
4. Literate patients, able to read and write in Bengali
5. Patients giving written consent to participate |
|
| ExclusionCriteria |
| Details |
1. Patients having severe degenerative changes as found in radiological findings
2. Patients having major disorder associated with lumbar spondylosis
3. Patients undergoing homeopathic treatment for any chronic disease within last 3 months.
4. Diagnosed cases of unstable mental or psychiatric illness or other uncontrolled or life - threatening illness affecting quality of life or any organ failure
5. Pregnancy and lactation
6. Substance abuse and/or dependence
7. Self-reported immune-compromised state |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Oswestry low back pain questionnaire |
At baseline, and every month, up to 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Roland Morris questionnaire |
At baseline, and every month, up to 3 months |
| McGill pain questionnaire short form (SF-MPQ) |
At baseline, and every month, up to 3 months |
|
|
Target Sample Size
|
Total Sample Size="66" Sample Size from India="66"
Final Enrollment numbers achieved (Total)= "55"
Final Enrollment numbers achieved (India)="55" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
18/11/2019 |
| Date of Study Completion (India) |
22/06/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Results arising out of the trial will be published in scientific journal in future |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Lumbar spondylosis (LS) is a degenerative disorder of the lumbar spine. Despite substantial research efforts, no gold-standard treatment for LS has been identified. The efficacy of individualized homeopathic medicines (IHMs) in LS has remained under-researched. In this study, the efficacy of IHMs was compared with identical-looking placebos in the treatment of LS. A double-blind, randomized (1:1), placebo-controlled trial was conducted at the National Institute of Homoeopathy, West Bengal, India. Patients were randomized to receive IHMs or identical-looking placebos, along with standardized concomitant care for both the groups. The Oswestry low back pain and disability questionnaire (ODQ) was the primary outcome; the Roland Morris questionnaire (RMQ) and the short form McGill pain questionnaire (SF-MPQ) were the secondary outcomes; each was measured at baseline and every month for 3 months. The intention-to-treat (ITT) sample was analyzed to detect any inter-group differences using two-ways repeated measures analysis of variance models overall and by unpaired t-tests at different time points. Enrolment was stopped prematurely because of time restrictions; 55 patients were randomized (verum: 28; control: 27); 49 were analyzed by ITT (verum: 26; control: 23). Inter-group differences in ODQ, RMQ and SF-MPQ total scores at 3 months were not statistically significant. SF-MPQ total score after 2 months revealed statistical significance, favoring IHMs against placebos. Some of the SF-MPQ subscales at different time points were also significant. Rhus toxicodendron, Sulphur and Pulsatilla nigricans were the most frequently indicated medicines. Owing to failure in detecting a statistically significant effect for the primary outcome and in recruiting a sufficient number of participants, our trial remained inconclusive. |