| CTRI Number |
CTRI/2023/06/053934 [Registered on: 15/06/2023] Trial Registered Prospectively |
| Last Modified On: |
02/06/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinical study to understand effect of homoeopathic medicines in Rheumatoid arthritis persons life quality. |
|
Scientific Title of Study
|
“A CLINICAL STUDY ON THE EFFECTIVENESS OF HOMOEOPATHIC
MEDICINES FOR IMPROVING THE QUALITY OF LIFE IN
RHEUMATOID ARTHRITIS†|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr KARTHIKA R K |
| Designation |
PG SCHOLAR |
| Affiliation |
Dr M.G.R Medical university, Chennai,White Memorial Homoeo Medical College And Hospital |
| Address |
Department of Practice of Medicine, White Memorial Homoeo Medical College and Hospital, Attoor, Veeyanoor P O
Kanniyakumari District,
Tamilnadu
629177.
Kanniyakumari
TAMIL NADU
629177
India |
| Phone |
9400993475 |
| Fax |
|
| Email |
drrkkarthikaratheesh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr R RICHARD FRANKLIN |
| Designation |
Professor and HOD Department of Practice of Medicine |
| Affiliation |
White Memorial Homoeo Medical College and Hospital |
| Address |
Department of Practice of Medicine, White Memorial Homoeo Medical College and Hospital, Attoor, Veeyanoor P O
Kanniyakumari District,
Tamilnadu
629177.
Kanniyakumari
TAMIL NADU
629177
India |
| Phone |
9486452262 |
| Fax |
|
| Email |
rrfranklin24@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr KARTHIKA R K |
| Designation |
PG SCHOLAR |
| Affiliation |
White Memorial Homoeo Medical College And Hospital |
| Address |
Department of Practice of Medicine, White Memorial Homoeo Medical College and Hospital, Attoor, Veeyanoor P O
Kanniyakumari District,
Tamilnadu
629177.
Kanniyakumari
TAMIL NADU
629177
India |
| Phone |
9400993475 |
| Fax |
|
| Email |
drrkkarthikaratheesh@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Practice of Medicine, WHITE MEMORIAL HOMOEO MEDICAL COLLEGE AND HOSPITAL, attoor, kanniyakumari, Tamilnadu |
|
|
Primary Sponsor
|
| Name |
Department of Practice of Medicine,White Memorial Homoeo Medical College and Hospital |
| Address |
White Memorial Homoeo Medical College And Hospital, Attoor, Veeyanoor P O
Kanniyakumari District, Tamilnadu
629177. |
| 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 KARTHIKA R K |
WHITE MEMORIAL HOMOEO MEDICAL COLLEGE & HOSPITAL |
Department of Practice of Medicine OPD unit, IPD unit, Health camps and Peripheral centers
Kanniyakumari
TAMIL NADU |
9400993475
drrkkarthikaratheesh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| WHITE MEMORIAL HOMOEO MEDICAL COLLEGE AND HOSPITAL ETHICS COMMITTEE WMHMCH- EC |
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 |
Assessment of Health Assessment Questionnaire – Disability Index (HAQ-DI) will be done at 3 months intervals. |
| Intervention |
Homoeopathic medicine |
Each case will be reviewed at 3-4 weeks intervals or as per their need in case of emergency, and it will be followed up for a period of 6 months. |
| Intervention |
Homoeopathic medicine |
Homoeopathic medicines selected based on symptom similarity will be administrated to the patients in the proper dose, potency, and repetition of medicines according to Homoeopathic principles. |
| Intervention |
Homoeopathic medicine |
potency- based on susceptability of the participant,
Dose- minimum dose, Route of administration- oral |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects belonging to both sexes.
2. Cases fulfilling the diagnostic criteria, 2010 ACR/EULAR criteria of rheumatoid arthritis.
3. Patients belonging to the age group 20-60 years. |
|
| ExclusionCriteria |
| Details |
1. Pregnant and Lactating Women.
2. Patients with known serious systemic illness.
3. Age less than 20 and more than 60.
4. Patients with stages 3 and 4. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Each case is assessed using Health Assessment Questionnaire – Disability Index (HAQ-DI), Each case will be reviewed at 3-4 weeks intervals or as per their need in case of emergency. |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| After completion of study follow up and assessment of Health Assessment Questionnaire – Disability Index (HAQ-DI) will be done |
1 year |
|
|
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)
|
20/06/2023 |
| 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
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) - All the data to be provided when needed through e mail drrkkarthikaratheesh@gmail.com
- For how long will this data be available start date provided 04-03-2025 and end date provided 04-03-2030?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
To study the effectiveness of Homoeopathic medicines for improving the Quality of Life in Patients with Rheumatoid Arthritis. Importance of the study: The positive outcome of this study will be beneficial to improving the Quality of life in Rheumatoid Arthritis patients in the future. Patients can use this treatment safely and thereby can reduce morbidity and mortality and also can overcome the side effects of conventional treatments. The cost-effectiveness of Homoeopathic treatment will help them to reduce the burden on family and society. |