| CTRI Number |
CTRI/2025/02/080926 [Registered on: 19/02/2025] Trial Registered Prospectively |
| Last Modified On: |
12/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Role of Calcarea flourica in Lumbar spondylosis in adults |
|
Scientific Title of Study
|
Effect of homoeopathic medicine Calcarea flourica in the treatment of Lumbar spondylosis among adults : a prospective single-arm clinical study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Not applicable |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ayushi Gaur |
| Designation |
PG Scholar |
| Affiliation |
Bakson Homoeopathic medical college and hospital |
| Address |
Department of Practice of Medicine
Basement Floor
Room no B16 and B17
Bakson Homoeopathic Medical College and Hospital
B36 Knowledge Park 1
Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
9627927180 |
| Fax |
|
| Email |
ayushigaura999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Akshay Mathur |
| Designation |
Guide and HOD |
| Affiliation |
Bakson Homoeopathic medical college and hospital |
| Address |
Department of Practice of Medicine
Basement Floor
Room no B16 and B17
Bakson Homoeopathic Medical College and Hospital
B36 Knowledge Park 1
Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
9868121727 |
| Fax |
|
| Email |
drakshaymathur@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashwini Nair |
| Designation |
HOD & PG incharge |
| Affiliation |
Bakson Homoeopathic medical college and hospital |
| Address |
Department of Homoeopathic Materia Medica
Second Floor
Room no S1
Bakson Homoeopathic Medical College and Hospital
B36 Knowledge Park I
Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
09990178024 |
| Fax |
|
| Email |
pginchargebakson@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bakson Homoeopathic Medical College and Hospital
B36 Knowledge Park 1
Gautam Budhha Nagar
Greater Noida UP
201310 |
|
|
Primary Sponsor
|
| Name |
Bakson homoeopathic medical college and hospital |
| Address |
Principal office
Ground floor
Room no G 22
Bakson homoeopathic medical college and hospital
B36 Knowledge Park 1
Greater Noida
Gautam Buddha Nagar
Uttar Pradesh
201310 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| NIL |
Not Applicable |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ayushi Gaur |
Bakson homoeopathic medical college and hospital |
Out Patient Department(OPD)
Ground floor
Room no 1
Bakson homoeopathic medical college and hospital
B36 Knowledge Park 1
Greater Noida
201310
Gautam Buddha Nagar
UTTAR PRADESH |
9627927180
drayushigaura999@gmail.com |
| Dr Ayushi Gaur |
Dr D P Rastogi Central Research Institute Of Homoeopathy |
Out Patient Department(OPD)
Ground floor A1/1
Room no 110
Sector 24
Noida 201301
Gautam Buddha Nagar
Gautam Buddha Nagar
UTTAR PRADESH |
09627927180
drayushigaura999@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Bakson Institutional Ethics Committee |
Approved |
| Kendriya Homoeopathic Anusandhan Parishad |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M47||Spondylosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Calcaria florica |
pill form
30 pill size
centesimal scale
oral route of administration
first dose at the time of case taking
subsequent doses according to follow ups for a period of 6 months. |
| Comparator Agent |
NIL |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
59.00 Year(s) |
| Gender |
Both |
| Details |
Adults aged 30 years to 59 years.
Confirmed diagnosis of lumbar spondylosis based on clinical evaluation and imaging studies
Symptoms such as lower back pain and stiffness present.
Participants who provide informed consent to participate in the study. |
|
| ExclusionCriteria |
| Details |
Individuals who have undergone recent surgery on the lumbar spine or adjacent areas within
the last six months.
Participants who has scoliosis
Participants with severe systemic illness (e.g. malignancies, uncontrolled diabetes, severe
cardiovascular diseases).
Pregnant or lactating women.
Participants deemed at high risk for non-compliance with the study protocol, including those with substance abuse issues or psychiatric disorders.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Changes can be seen on Visual Analog Scale VAS
Changes can be positive or negative or no change |
15 months
Enrollment period for 6 Months
Follow Up every month for 6 Months
Study & Data Analysis for 3 months
First dose will be given after case taking
Subsequent doses according to the follow ups for a period of 6 months
VAS scale will be used as baseline at 3rd months and at 6th months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
Not applicable |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
25/02/2025 |
| 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="3"
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
|
This prospective single-arm clinical study aims to evaluate the effect of Homoeopathic medicine Calcarea Fluorica in the centesimal potency in the cases of lumbar spondylosis among adults, focusing on clinical outcomes such as pain relief and improvement in mobility. Primary outcome is to assess the changes in visual analogue scale (VAS) . VAS will be used at baseline, at 3rd month and at 6th month for analysis. The result will be concluded accordingly. Study duration is 15 months. Sample size will be 42. |