| CTRI Number |
CTRI/2025/03/083647 [Registered on: 28/03/2025] Trial Registered Prospectively |
| Last Modified On: |
28/03/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Individualized Homoeopathic medicines in Lumbar spondylosis. |
|
Scientific Title of Study
|
Add on effect of homoeopathy to yoga in the management of lumbar spondylosis: A randomized controlled trial |
| 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 Laijun Nahar |
| Designation |
Research Officer,(Homoeopathy) Scientist-1 |
| Affiliation |
Central Council for Research in Homoeopathy |
| Address |
Room no: OPD 1,
Dr. Anjali Chatterji Regional Research Institute for Homoeopathy, 50 Rajendra Chatterjee Road
North Twentyfour Parganas
WEST BENGAL
700035
India |
| Phone |
7980274752 |
| Fax |
|
| Email |
laijun786@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Laijun Nahar |
| Designation |
Research Officer, (Homoeopathy) Scientist-1 |
| Affiliation |
Central Council for Research in Homoeopathy |
| Address |
Room no: OPD 1, Dr. Anjali Chatterji Regional Research Institute for Homoeopathy, 50 Rajendra Chatterjee Road
North Twentyfour Parganas
WEST BENGAL
700035
India |
| Phone |
7980274752 |
| Fax |
|
| Email |
laijun786@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Laijun Nahar |
| Designation |
Research Officer, (Homoeopathy) Scientist-1 |
| Affiliation |
Central Council for Research in Homoeopathy |
| Address |
Room no: OPD 1, Dr. Anjali Chatterji Regional Research Institute for Homoeopathy, 50 Rajendra Chatterjee Road
North Twentyfour Parganas
WEST BENGAL
700035
India |
| Phone |
7980274752 |
| Fax |
|
| Email |
laijun786@gmail.com |
|
|
Source of Monetary or Material Support
|
| Director General, Central Council for Research in Homoeopathy, 61-65 Institutional Area, Opposite D Block, Janakpuri, New Delhi: 110058 |
|
|
Primary Sponsor
|
| Name |
Director General, Central Council for Research in Homoeopathy |
| Address |
61-65, Institutional Area, Opp. D Block, Janakpuri, New Delhi-110058 |
| Type of Sponsor |
Research institution |
|
|
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 Laijun Nahar |
Dr. Anjali Chatterji Regional Research Institute for Homoeopathy, Kolkata |
Room no: OPD 1, Dr. Anjali Chatterji Regional Research Institute for Homoeopathy, 50, Rajendra Chatterjee Road, Near Onkar Petrol Pump
North Twentyfour Parganas
WEST BENGAL |
7980274752
laijun786@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of Dr. Anjali Chatterji Regional Research Institute for Homoeopathy, Kolkata |
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 |
Homoeopathic medicine add on with yoga |
Homoeopathic medicines as detailed in the standard Homoeopathic Materia Medica
and in the Homoeopathic Pharmacopoeia (India/US) will be used in the study on the
basis of homoeopathic principles. The medicines identified for the trial shall be
procured from a GMP compliant pharmaceutical firm approved by the Council.
Medicines will be dispensed in sugar globules of standard size 30 or in distilled
water. Indicated medicine will be repeated as per the need of each case depending on the intensity of symptoms. Along with homoeopathic medicines yoga practices advised (by qualified yoga expert) to the all-enrolled patient.
Route of administration: The medicine should be taken orally on a clean tongue and an empty stomach.
Duration of therapy: 3 months |
| Comparator Agent |
Yoga |
Yoga practices by qualified yoga expert.
Duration of therapy: 3 months |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Age between 30 to 70 years.
2. Both male and female patients.
3. Participants with chronic low back pain due to lumbar spondylosis (M47.8) of more than 3 months duration.
4. Participants with a radiological diagnosis of lumbar spondylosis with mild to moderate degenerative radiological changes.
5. A pain intensity of 5 or higher on a numerical rating scale of 0 to 10 is required for enrollment.
6. Washout phase of conventional or other medications for lumbar spondylosis, if any of, 2 weeks prior to enrollment.
7. Participants who are willing to give informed consent to participate in the study.
|
|
| ExclusionCriteria |
| Details |
1. Participants with severe degenerative changes as found radiologically and those with major spinal disorders associated with LS.
2. Low back pain with systemic disorders (i.e., Primary joint disease such as active rheumatoid arthritis; Metabolic bone disease; Malignant bone disease; Uncontrolled DM and HTN, Cardiovascular, CKD and other severe illness, not able to consultation)
3. Pregnancy or lactation
4. Critically patients requiring orthopedic corrections
5. Substance abuse, alcoholism
6. Psychologically unstable patients. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The Bournemouth questionnaire (BQ) score for pain |
Baseline and every month up to 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Measurement of back-related disability through Modified Oswestry disability questionnaire (MODQ) for Indian population |
Baseline and every month up to 3 months |
| Modified Naranjo Criteria for Homeopathy (MONARCH) may be taken as secondary outcome for evaluating the causal attribution between the given intervention and the clinical improvement at the end of treatment. |
At the end of study i.e., after 3 months of study |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
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 3 |
|
Date of First Enrollment (India)
|
10/07/2025 |
| 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="7"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Low back pain is a common musculo-skeletal disorder with a 70% lifetime prevalence that causes major economic losses through medical and lost work days costs. The occurrence of low back pain in Indian population is alarming with nearly 60% to 80% of the people in this country have suffered from low back pain at some time during their lifespan. Low back pain is a leading cause of disability. Conventional medical treatment have many side effects. CAM therapy is being popular in patients with musculo-skeletal disorders including LBP. There are several studies showing that the homoeopathic medicines and yoga practices are effective in LBP but the studies showing comparative as well as additive effect of homoeopathy and yoga in chronic LBP are lacking even after going through different search portals. To fulfil this research-gap this RCT will be conducted following the strict guidelines as per the protocol. In this project, we intend to compare the effect of individualized homoeopathy with add-on to Yoga practices (YP) and patients on Yoga practices (YP) alone in 72 patients suffering from chronic low back pain due to lumbar spondylosis using Bournemouth questionnaire and Modified Oswestry disability questionnaire (MODQ) at baseline and every month up to 3 months of study at Dr. Anjali Chatterji Regional Research Institute for Homoeopathy, Kolkata, West Bengal, India. It is an open label, randomized (1:1), parallel arm, comparative trial. The generated results will undergo statistical analysis and will be published in scientific journal.
|