| CTRI Number |
CTRI/2024/05/067425 [Registered on: 15/05/2024] Trial Registered Prospectively |
| Last Modified On: |
15/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Understanding how Homoeopathy helps in treating Rheumatoid Arthritis based on mind symptoms. A clinical study using Homoeopathic Medical Repertory by Dr. Robin Murphy. |
|
Scientific Title of Study
|
Significance of Mind rubrics as eliminating rubric in indicating Homoeopathic Similimum in the management of patients with Rheumatoid Arthritis using Homoeopathic Medical Repertory by Dr Robin Murphy as a tool. A Prospective Open Label Single Arm Interventional 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 Shakthi Vigneshwar G |
| Designation |
Postgraduate trainee |
| Affiliation |
State National Homoeopathic Medical College and Hospital Lucknow |
| Address |
Department of Case Taking and Repertory State National Homoeopathic Medical College and Hospital 1-Viraj khand Gomti Nagar Lucknow.
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
8838959561 |
| Fax |
|
| Email |
appumanon@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vinay Shankar Tiwari |
| Designation |
Reader |
| Affiliation |
State National Homoeopathic Medical College and Hospital Lucknow |
| Address |
Department of Homoeopathic Pharmacy State National Homoeopathic Medical College and Hospital 1-Viraj khand Gomti Nagar Lucknow UTTAR PRADESH 226010
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
9893084182 |
| Fax |
|
| Email |
drvinaytiwariarogya@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shakthi Vigneshwar G |
| Designation |
Postgraduate trainee |
| Affiliation |
State National Homoeopathic Medical College and Hospital Lucknow |
| Address |
Department of Case Taking and Repertory State National Homoeopathic Medical College and Hospital 1-Viraj khand Gomti Nagar Lucknow
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
8838959561 |
| Fax |
|
| Email |
appumanon@gmail.com |
|
|
Source of Monetary or Material Support
|
| Out patient department of State National Homoeopathic Medical College and Hospital 1-viraj khand Gomti Nagar Lucknow UTTARPRADESH 226010 |
|
|
Primary Sponsor
|
| Name |
Dr Shakthi Vigneshwar G |
| Address |
Department of Case Taking and Repertory State National Homoeopathic Medical College and Hospital 1-viraj khand Gomti Nagar Lucknow Uttar Pradesh -226010 |
| Type of Sponsor |
Other [self] |
|
|
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 Shakrhi Vigneshwar G |
State National Homoeopathic Medical College and Hospital Lucknow |
OPD-8 Department of Case Taking and Repertory State National Homoeopathic Medical College and Hospital 1-Viraj khand Gomti Nagar Lucknow.
Lucknow
UTTAR PRADESH |
8838959561
appumanon@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of State National Homoeopathic Medical College and Hospital Lucknow |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M069||Rheumatoid arthritis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualized Homoeopathic Medicine Using Homoeopathic Medical Repertory By Dr Robin Murphy |
Patients qualifying to inclusion criteria will be included in the study. Proper case taking of all enrolled patients will be done in standardized case taking proforma which is being used in State National Homoeopathic medical college and hospital. Homoeopathic medicines will be prescribed to all patients after analysis and evaluation of symptoms and proper repertorization using Homoeopathic Medical Repertory by Dr Robin Murphy. Indicated homoeopathic remedy will be administered as decided appropriate to the case or condition in appropriate potency and doses. Medicines will be given oral route. Each case will be followed up at regular interval preferably at a period of 15 days or as per requirement. Patient will be studied for 6 months after enrolment in study. Outcome assessment of the patients will be carried out after 6 months of homoeopathic medication based on Disease Activity Score 28 and Rheumatoid Arthritis Disease Activity Index – 5 Questionnaire at the end of 6 months. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient who are willing for inclusion in the study and giving consent to participate and those who are able to come for the further follow-ups.
2. Patients satisfying (with the score of ≥ 6) the 2010 ACR/EULAR criteria for diagnosis of Rheumatoid Arthritis.
3. Patients belonging to both sexes.
4. Patient belonging to the age group of between 20 years to 80 years.
5. Improvement criteria is based on Disease Activity Score in 28 joints (DAS28) and Rheumatoid Arthritis Disease Activity Index - 5 (RADAI-5) Questionnaire. |
|
| ExclusionCriteria |
| Details |
1. Patient unwilling for inclusion in the study and those who are not able to come for follow-ups.
2. Patients taking treatment from any other systems of medicine for Rheumatoid arthritis. Patients with known immune-compromised diseases or other severe systemic illness.
3. Patients with other known auto-immune diseases.
4. Patients with malignancies or other severe systemic illnesses.
5. Pregnant and lactating women.
6. Any other condition requiring emergency or surgical intervention. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effect of individualized homoeopathic medicine selected using mind rubrics as eliminating rubric from Homoeopathic Medical Repertory by Dr Robin Murphy using Rheumatoid Arthritis Disease Activity Index - 5 Questionnaire (RADAI-5) before and after the treatment. |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effect of individualized homoeopathic medicine selected using mind rubrics as eliminating rubric from Homoeopathic Medical Repertory by Dr Robin Murphy using Disease Activity Score in 28 joints (DAS28) Rheumatoid Arthritis Disease Activity Index - 5 Questionnaire (RADAI-5) before and after the treatment. |
3 months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
26/05/2024 |
| 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="6"
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
|
Rheumatoid arthritis (RA) is a chronic multisystem disease of unknown cause. Although there are a variety of systemic manifestations, the characteristic feature of RA is persistent inflammatory synovitis, usually involving peripheral joints in a symmetric distribution. The potential of the synovial inflammation to cause cartilage destruction and bone erosions and subsequent changes in joint integrity is the hallmark of the disease. Despite its destructive potential, the course of RA can be quite variable. Some patients may experience only a mild oligoarticular illness of brief duration with minimal joint damage, whereas others will have a relentless progressive polyarthritis with marked functional impairment. At the end of study, it is expected that the individualized homoeopathic medicine selected using mind rubrics as eliminating rubric from Homoeopathic Medical Repertory by Dr Robin Murphy have effective role in the management of patients who are suffering with Rheumatoid Arthritis. It is expected that the patient improves symptomatically which is evident through the valid scales (Diseased Activity Score DAS28 and Rheumatoid Arthritis Disease Activity Index RADAI 5). This study will further emphasize the importance of mind symptoms in treating patients suffering from chronic systemic illnesses like Rheumatoid Arthritis. |