| CTRI Number |
CTRI/2024/12/078524 [Registered on: 24/12/2024] Trial Registered Prospectively |
| Last Modified On: |
17/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
usefulness of homoeopathic medicines in the management of rheumatoid arthritis |
|
Scientific Title of Study
|
Evaluating the usefulness of individualized homoeopathic medicines in the management of rheumatoid arthritis A prospective single arm pre post 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 Gurleen Kaur |
| Designation |
PG Scholar |
| Affiliation |
Bakson Homoeopathic Medical college and Hospital |
| Address |
Department of Homoeopathic Materia medica
second floor
room no S1
Bakson Homoeopathic Medical college and hospital
36 B
Phase 1
Knowledge Park 1
Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
8287363613 |
| Fax |
|
| Email |
kaurgahuja01@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashwini Nair |
| Designation |
Guide and 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
36 B
Phase 1
Knowledge Park 1
Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
9990178024 |
| Fax |
|
| Email |
pginchargebakson@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashwini Nair |
| Designation |
Guide and 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
36 B
Phase 1
Knowledge Park 1
Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
9990178024 |
| Fax |
|
| Email |
pginchargebakson@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bakon Homoeopathic Medical college and Hospital
36 B
Phase 1
Knowledge park 1
Gautam buddha Nagar
Greater Noida
Uttar Pradesh
201310
India
|
|
|
Primary Sponsor
|
| Name |
Bakon Homoeopathic Medical college and Hospital |
| Address |
Principal office Ground floor
room no G 22
Bakson Homoeopathic Medical college and Hospital and Hospital
36 B
Phase 1
Knowledge park 1
Gautam buddha Nagar
Greater Noida
Uttar Pradesh
201310 |
| Type of Sponsor |
Private medical college |
|
|
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 Gurleen kaur |
Bakson Homoeopathic Medical college and Hospital |
Outpatient department (OPD)
Ground floor
room no 1
Bakson Homoeopathic Medical college and Hospital
36 B
Phase 1
Knowledge Park 1
Greater Noida
201310
Gautam Buddha Nagar
UTTAR PRADESH |
8287363613
kaurgahuja01@gmail.com |
| Dr Gurleen kaur |
Dr DP Rastogi Central Research Institute of Homoeopathy |
Outpatient department (OPD)
Ground floor
A1/1
Room no 110
sector 24
Noida
201301
Gautam Buddha Nagar
UTTAR PRADESH |
8287363613
kaurgahuja01@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: M05||Rheumatoid arthritis with rheumatoid factor, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Homoeopathic medicine |
oral route of administration
Pill Form
30 pill size
centesimal scale
First dose at the time of case taking
subsequent doses according to the follow up
Potency according to the case |
| Comparator Agent |
not applicable |
not applicable |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
59.00 Year(s) |
| Gender |
Both |
| Details |
Males and females of age group 25-59 years Participants fulfilling 2010 ACR EULAR criteria for definite RA
Participants who will give the voluntary consent
|
|
| ExclusionCriteria |
| Details |
Clinically diagnosed cases of any systemic illnesses due to extra-articular effects of RA or any other cause.
Participants with DAS-28 CRP SCORE value greater than 5.1 indicating high disease activity.
Participants with HAQ-DI score above 2
Participants with any psychiatric illness or those under any drug abuse
Pregnant and lactating females
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| changes in the DAS-28 CRP score |
at the baseline, third month and sixth month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| changes in Health Assessment questionnaire – Disability Index (HAQ-DI) score and value of Rheumatoid factor as well as listing out the most commonly indicated medicines |
HAQ-DI at every month and Rheumatoid factor value at the baseline, 3rd & 6th month |
|
|
Target Sample Size
|
Total Sample Size="34"
Sample Size from India="34"
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)
|
27/12/2024 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study aims to evaluate the usefulness of individualized homoeopathic medicines in the management of Rheumatoid Arthritis by assessing the changes in DAS-28 CRP score, HAQ-DI score and Rheumatoid factor. A total of 34 participants, including both males and females between the age groups 25-59, with DAS-28 CRP Score below 5.1 and HAQ-DI score below 2 will be enrolled from the OPD/POPD of Bakson Homoeopathic Medical College and Hospital, Greater Noida and Dr. D.P Rastogi Central Research Institute, Greater Noida after obtaining a voluntary consent from the participants. Individualized homoeopathic medicines will be prescribed after detailed case taking and repertorization. Follow ups will be taken every month along with the calculation of HAQ-DI scores Rheumatoid factor, DAS-28 CRP values will be collected at the baseline, third month and at sixth month. The final data analysis will be done in the last three months of the study by applying suitable biostatistical tests on the data collected.
|