| CTRI Number |
CTRI/2024/12/078646 [Registered on: 27/12/2024] Trial Registered Prospectively |
| Last Modified On: |
26/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Role of cimicifuga racemosa and other homoeopathic medicines in cases of cervical spondylosis in adults |
|
Scientific Title of Study
|
Effect of cimicifuga racemosa and individualized homoeopathic medicines in management of cervical spondylosis in adults a prospective comparative 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 Vaishali Rajput |
| Designation |
Pg scholar |
| Affiliation |
Bakson homoeopathic medical and hospital |
| Address |
Department of homoeopathic materia medica
second floor
room no S1
Bakson homoeopathic medical college and hospital
B 36
Knowledge park I
Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
7906184264 |
| Fax |
|
| Email |
vaishalirajput.ktp@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Preeti Laroia |
| Designation |
Guide & Professor |
| Affiliation |
Bakson homoeopathic medical and hospital |
| Address |
Department of homoeopathic materia medica
second floor
room no S1
Bakson homoeopathic medical college and hospital
B 36
Knowledge park I
Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
9312352020 |
| Fax |
|
| Email |
preeti.laroia@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashwini Nair |
| Designation |
HOD & Pg incharge |
| Affiliation |
Bakson homoeopathic medical and hospital |
| Address |
Department of homoeopathic materia medica
second floor
room no S1
Bakson homoeopathic medical college and hospital
B 36
Knowledge park I
Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
9990178024 |
| Fax |
|
| Email |
pginchargebakson@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bakson Homoeopathic Medical College and Hospital
B 36 Knowledge park 1
Greater Noida
Gautam Buddha Nagar
201310
Uttar Pradesh
India |
|
|
Primary Sponsor
|
| Name |
Bakson Homoeopathic Medical College and Hospital |
| Address |
Principal Office
Ground Floor
Room No G22
Bakson Homoeopathic Medical College and Hospital
B 36
Knowledge park 1
Greater Noida
Gautam Buddha Nagar
201310
Uttar Pradesh |
| 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 Vaishali Rajput |
Bakson Homoeopathic Medical College and Hospital |
Out Patient Department (OPD)
Ground Floor
Room No 1
Bakson Homoeopathic Medical College and Hospital
B 36
Knowledge Park 1
Greater Noida
201310
Gautam Buddha Nagar
UTTAR PRADESH |
7906184264
vaishalirajput.ktp@gmail.com |
| Dr Vaishali Rajput |
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
UTTAR PRADESH |
07906184264
vaishalirajput.ktp@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: M478||Other spondylosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Cimicifuga Racemosa |
Pill Form
30 pill size
Oral route of administration Centesimal scale
First dose at the time of case taking subsequent doses according to follow ups for a period of 6 months |
| Intervention |
Individualized Homoeopathic Medicine |
Pill Form
30 pill size
Oral route of administration
Centesimal scale
First dose at the time of case taking subsequent doses according to follow ups for a period of 6 months |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
59.00 Year(s) |
| Gender |
Both |
| Details |
Participants presenting with signs and symptoms of cervical spondylosis
X- Ray grading, I & II with minimum to definite anterior osteophytosis with possible narrowing of disc space
Both male and female participants between 20-59 years of age
|
|
| ExclusionCriteria |
| Details |
Participants with any severe systemic illnesses
Participants with radiculopathy and myelopathy
Pregnant and lactating mothers
Participants of malignancy, fracture, primary neurological disease, previous surgery of neck
Participants with any psychiatric illness
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Changes will be observed on NDI scale
Changes can be positive or negative or no changes |
NDI scale will be used at baseline, every 2 weeks upto 24 weeks
15 months study
6 months enrolment
3 months follow up
3 months analysis
first dose at the time of case taking and subsequent doses according to follow up
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
N/A |
|
|
Target Sample Size
|
Total Sample Size="68"
Sample Size from India="68"
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)
|
10/01/2025 |
| 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 is a randomized comparative parallel arm study, to compare the effect of cimicifuga racemosa and individualized homoeopathic medicines in the management of cervical spondylosis by using NDI scale. The primary outcome is to assess the change in NDI scale in both groups at baseline and after treatment period of 6 months. |