| CTRI Number |
CTRI/2025/12/099105 [Registered on: 15/12/2025] Trial Registered Prospectively |
| Last Modified On: |
03/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
To assess the efficacy of homoeopathic medicine in management of lumbar spondylosis. |
|
Scientific Title of Study
|
Assessment of the efficacy of homoeopathic medicines in management of lumbar spondylosis- a randomised controlled clinical 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 Ayush Kumar |
| Designation |
Associate Professor Department of Homoeopathic Materia Medica |
| Affiliation |
Dr D Y Patil Homoeopathic Medical College and Research Centre Pimpri Pune |
| Address |
Department of Homoeopathic Materia Medica, Ground floor, room no. 2
Sant Tukaram Nagar Pimpri Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
8793358167 |
| Fax |
|
| Email |
ayush.kumar@dpu.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dharmendra Sharma |
| Designation |
Principal |
| Affiliation |
Dr D Y Patil Homoeopathic Medical College and Research Centre Pimpri Pune |
| Address |
Ground floor, room- Principal cabin
Sant Tukaram Nagar Pimpri Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9422330045 |
| Fax |
|
| Email |
principal.homoeopathy@dpu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ayush Kumar |
| Designation |
Associate Professor Department of Homoeopathic Materia Medica |
| Affiliation |
Dr D Y Patil Homoeopathic Medical College and Research Centre Pimpri Pune |
| Address |
Department of Homoeopathic Materia Medica, Ground floor, room no. 2
Sant Tukaram Nagar Pimpri Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
8793358167 |
| Fax |
|
| Email |
ayush.kumar@dpu.edu.in |
|
|
Source of Monetary or Material Support
|
| Infrastructure of OPD and IPD of Dr D Y Patil Homoeopathic Medical College and Research Centre Pimpri Pune will be utilised for study. As mentioned in the site, patients of OPD and IPD of the hospital will also be part of the study. |
|
|
Primary Sponsor
|
| Name |
Dr Ayush Kumar |
| Address |
Dr D Y Patil Homoeopathic Medical College and Research Centre Pimpri Pune
Sant Tukaram Nagar Pimpri Pune 411018
|
| Type of Sponsor |
Other [It is self sponsored project with no external funding] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ayush Kumar |
Dr D Y Patil Homoeopathic Medical College and Research Centre |
1st Floor, Homoeopathic Hospital OPD and IPD
Sant Tukaram Nagar Pimpri Pune 411018
Pune
MAHARASHTRA |
8793358167
ayush.kumar@dpu.edu.in |
| Dr Ayush Kumar |
Krishna Homoeopathic Clinic |
1st floor, Shop no. 14, Bhondave Empire, Ganesh Nagar, Pipeline Road, Shinde Vasti, Ravet, Pune- 412410
Pune
MAHARASHTRA |
08793358167
ayush.kumar@dpu.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr D Y Patil Homoeopathic Medical College and Research Centre Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M479||Spondylosis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Indicated homoeopathic medicine and physiotherapy |
Indicated homoeopathic medicine will be administered along with physiotherapy to 50 patients of lumbar spondylosis. Its effects will be compared with the comparator which is placebo with physiotherapy. |
| Comparator Agent |
Placebo and physiotherapy |
Placebo will be given along with physiotherapy to another 50 patients of lumbar spondylosis. Its effects will be compared with intervention which is indicated homoeopathic medicine along with physiotherapy. |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1- Pre-diagnosed cases of Lumbar spondylosis in male and female patients between 35 to 65 years of the age group will be included in this study.
2- Cases will be included based on Kellgren and Lawrence classification, grade 1 and grade 2.
|
|
| ExclusionCriteria |
| Details |
1- Patients don’t give consent for the treatment.
2- Patients having irregular follow-ups.
3- H/o Spinal Injury, Lumbo-sacral injury (fracture).
4- Lumbar Disc Herniation, Disc Prolapse, Lumbar Canal Stenoenosis, or any gross pathology in spine which can lead to complication
5- Pregnant women
6- Age –above 65 years
7- Kellgren and Lawrence classification grade 3 and grade 4. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the therapeutic effectiveness of homoeopathic medicines in reducing pain and improving mobility, in patients with lumbar spondylosis compared to a placebo group. |
6 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the long-term effectiveness of homoeopathic treatment in maintaining symptom relief and preventing the progression of lumbar spondylosis. |
6 months |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
15/12/2025 |
| 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="3"
Months="0"
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 - 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 - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [ayush.kumar@dpu.edu.in].
- For how long will this data be available start date provided 15-12-2025 and end date provided 14-12-2028?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
|
Brief Summary
|
The 2010 Global Burden of Disease Study estimated that low back pain is amongst the top 10 diseases and injuries that account for the highest number of disability. Homoeopathic medicines are very effective in the treatment of lumbar spondylosis. These medicines not only relieve the symptoms of lumbar spondylosis i.e. pain, stiffness, numbness, and functional disability but also improve the quality of life. Homoeopathic medicines can prevent spine compression and osteophyte formation. This study was undertaken to fill the knowledge gap and further explore the effectiveness of homoeopathic management in lumbar spondylosis. This study aims to assess the efficacy of homoeopathic medicines in management of Lumbar Spondylosis. |