| CTRI Number |
CTRI/2025/09/095458 [Registered on: 29/09/2025] Trial Registered Prospectively |
| Last Modified On: |
29/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effect of homeopathy medicines on lower back pain (Lumbago). |
|
Scientific Title of Study
|
To assess the effectiveness of individulized homoeopathic intervention in cases of lumbago using NPRS-A randomized parallel arm placebo controlled study |
| 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 Vandana Yadav |
| Designation |
PG Scholar |
| Affiliation |
Dr M P K Homoeopathic Medical College Hospital and Research Centre |
| Address |
Department of Organon of Medicine Dr M P K Homoeopathic Medical College Hospital and Research Centre a constituent college of Homoeopathy University Saipura Sanganer Jaipur
Jaipur
RAJASTHAN
302029
India |
| Phone |
6392305732 |
| Fax |
|
| Email |
drvandana1209@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr S N Sharma |
| Designation |
Professor |
| Affiliation |
Dr M P K Homoeopathic Medical College Hospital and Research Centre |
| Address |
Department of Organon of Medicine Dr M P K Homoeopathic Medical College Hospital and Research Centre a constituent college of Homoeopathy University Saipura Sanganer Jaipur
Jaipur
RAJASTHAN
302029
India |
| Phone |
9414320633 |
| Fax |
|
| Email |
raghavdrsn@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vandana Yadav |
| Designation |
PG Scholar |
| Affiliation |
Dr M P K Homoeopathic Medical College Hospital and Research Centre |
| Address |
Department of Organon of Medicine Dr M P K Homoeopathic Medical College Hospital and Research Centre a constituent college of Homoeopathy University Saipura Sanganer Jaipur
Jaipur
RAJASTHAN
302029
India |
| Phone |
6392305732 |
| Fax |
|
| Email |
drvandana1209@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Girendra Pal Homoeopathic Hospital and Research Centre Collegiate Hospital of Dr M P K Homoeopathy University Saipura Sanganer Jaipur Rajasthan 302029 |
|
|
Primary Sponsor
|
| Name |
Dr M P K Homoeopathic Medical College Hospital and Research Centre |
| Address |
10, 11, 12, Ward no 36 Saipura Sanganer, Jaipur, Rajasthan-302029 |
| Type of Sponsor |
Private 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 Vandana Yadav |
Dr Girendra Pal Homoeopathic Hospital and Research Centre |
Department of Organon of Medicine OPD Room No 2 Dr M P K Homoeopathic Medical College Hospital and Research Centre a constituent college of Homoeopathy University 10, 11, 12, Ward No 36 Saipura, Sanganer, Jaipur, Rajasthan- 302006
Jaipur
RAJASTHAN |
6392305732
drvandana1209@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee by Homoeopathy University Jaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M479||Spondylosis, unspecified, (2) ICD-10 Condition: M478||Other spondylosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Homoeopathic Medicine selected on the basis of placebo controlled according to Richard Hughes |
Homoeopathic medicine shall be given orally in centesimal potency as per case and Hahnemannian Guidelines given in the 5th edition of Organon of Medicine in the form of Globule No 40 Dose and repetition as per need of case and reassessment at the end of 3 month |
| Intervention |
Homoeopathic Medicine selected on the basis of totality of Symptoms |
Homoeopathic medicine shall be given orally in centesimal potency as per case and Hahnemannian Guidelines given in the 5th edition of Organon of Medicine in the form of Globule No 40 Dose and repetition as per need of case and reassessment at the end of 3 month |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed with lumbago (low back pain) with or without radiation, persisting for more than 6 weeks. Willing to participate and provide informed written consent. Baseline NPR Score greater than or equal to 4 |
|
| ExclusionCriteria |
| Details |
Pain due to trauma, malignancy, infections or systemic diseases. Pregnant women and lactating women will not be included in the study. Patients with structural deformities (e.g. severe scoliosis or ankylosing spondylitis). Patients undergoing other concurrent pain managment therapies (NSAIDs, physiotherapy). Known psychiatric illness or cognitive impairment that may be interfere with reporting. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| On the basis of NPRS- Pre and Post test scores of lumbago. |
Pre score will be taken at baseline of treatment and post score will be assessed at the end of study that is 12 weeks using NPRS test scores of lumbago. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The study is expected to show effectiveness of homoeopathic medicines selected on the basis of totality of symptoms in cases of lumbago. |
12 months |
| The Study is pxpected to show effectiveness of homoeopathic medicines selected on the basis of placebo controlled in cases of lumbago. |
12 Months |
| The Study will help to compare the two methods- Totality of symptoms and plecebo controlled in the selection of medicine in the cases of Lumbago. |
12 Months |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
30/10/2025 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Aim: To assess the effectiveness of individulized homoeopathic intervention for pain management in cases of lumbago using NPRS.
To evaluate the effect of individulised homoeopathic intervention for pain managment in cases of lumbago using pre and post NPRS.
To analyse different prescription approaches in providing pain relief ini cases of lumbago.
To assess the predominant miasm in the cases of lumbago. |