| CTRI Number |
CTRI/2025/07/090657 [Registered on: 10/07/2025] Trial Registered Prospectively |
| Last Modified On: |
09/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study of individualized homoeopathic medicine for rheumatoid arthritis |
|
Scientific Title of Study
|
Effectiveness of individualized homoeopathic medicine in treatment of rheumatoid arthritis - A Quasi experimental 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 |
DrLVenkata Nagasai Charitha |
| Designation |
Post Graduate Trainee, Department of practice of Medicine |
| Affiliation |
National Homoeopathic Research Institute in Mental Health, kurichy, kottayam- |
| Address |
National Homoeopathic Research Institute in Mental Health,
Sachivothamapuram p.o, kurichy, kottayam-686532 kerala India
Kottayam
KERALA
686532
India
Kottayam
KERALA
686532
India |
| Phone |
9014278134 |
| Fax |
|
| Email |
charithaladdagiri@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrR Sitharthan |
| Designation |
BHMS,MD(Hom), PhD( Hom), PRINCIPAL, PROFESSOR , DEPARTMENT OF MEDICINE |
| Affiliation |
National Homoeopathic Research Institute in Mental Health, kurichy, kottayam |
| Address |
National Homoeopathic Research Institute in Mental Health,
Sachivothamapuram p.o, kurichy, kottayam-686532 kerala India
Kottayam
KERALA
686532
India
Kottayam
KERALA
686532
India |
| Phone |
9443203174 |
| Fax |
|
| Email |
sitharthan.r@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrR Sitharthan |
| Designation |
BHMS,MD(Hom), PhD( Hom), PRINCIPAL, PROFESSOR , DEPARTMENT OF MEDICINE |
| Affiliation |
National Homoeopathic Research Institute in Mental Health, kurichy, kottayam |
| Address |
National Homoeopathic Research Institute in Mental Health,
Sachivothamapuram p.o, kurichy, kottayam-686532 kerala India
Kottayam
KERALA
686532
India
Kottayam
KERALA
686532
India |
| Phone |
9443203174 |
| Fax |
|
| Email |
sitharthan.r@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Homoeopathic Research Institute in Mental Health |
|
|
Primary Sponsor
|
| Name |
Dr.L.venkata Nagasai Charitha |
| Address |
National Homoeopathic Research Institute in Mental
Health,Sachivothamapuram p o, kurichy, kottayam,
kerala-686532,India. |
| 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 |
| DrLvenkata Nagasai Charitha |
National Homoeopathy Research Institute in Mental Health (NHRIMH) |
OPD,IPD
,PERIPHERAL CAMPS
AND
UNITS,DEPARTMENT
OF PRACTICE OF
MEDICINE,NATIONAL
HOMOEOPATHY
RESEARCH
INSTITUTE IN
MENTAL HEALTH,SAC
CHIVOTTAMAPURAM
(P.O),KURICHY
,KERALA
686532,INDIA
Kottayam
KERALA
Kottayam
KERALA |
9014278134
charithaladdagiri@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M048||Other autoinflammatory syndromes, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualized homeopathic medicine |
After enrollment the case will be
repertorised.Appropriate
potentized Individualised
Homoeopathic Medicine will be
administered in minimum dose
in appropriate potency
according to the need of the
case. Medicine is administered
orally. Repetition will be done
when improvement comes to a
standstill in a higher potency of the same medicine and if the
medicine is not found to be
effective the case will be
retaken then another
appropriate medicine is given.
The above homoeopathic
intervention will be given for a
period of 6 months. |
| Comparator Agent |
Not applicable |
Not applicable |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
20-70years both males and females
,Patients presenting with symmetrical polyarthritis
, Anti-CCP antibodies greater than 20IU/mL |
|
| ExclusionCriteria |
| Details |
Patients with other severe systemic illness
,Pregnant women, lactating mothers,
Immunocompromised patients |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the effectiveness of individualized homoeopathic medication in reducing the
disease activity in rheumatoid arthritis measured by simplified Disease Activity Index(SDAI). |
Baseline,3rd month,6th month,9th month,12th month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the effectiveness of homoeopathic medicine in reducing the
levels of anti-CCP in rheumatoid arthritis. |
Baseline,6th month and end of study |
|
|
Target Sample Size
|
Total Sample Size="38"
Sample Size from India="38"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
20/07/2025 |
| 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="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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [charithaladdagiri@gmail.com].
- For how long will this data be available start date provided 20-07-2025 and end date provided 11-11-2027?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
|
Brief Summary
|
This study aims to evaluate the effectiveness of individualized homoeopathic medicine in the treatment
of Rheumatoid Arthritis (RA). It is designed as a quasi-experimental, prospective clinical trial conducted
at the National Homoeopathy Research Institute in Mental Health, Kottayam. The primary objective is
to assess clinical improvement in RA symptoms using the Simplified Disease Activity Index (SDAI), while
the secondary objective is to examine changes in anti-CCP antibody levels, which are highly specific
biomarkers for RA.A total of 38 patients, selected via purposive sampling, will be enrolled based on
criteria including ACR score greater than or equal to 6 and anti-CCP greater than 20 IU/mL, ensuring the inclusion of patients with
definitive RA and a significant autoimmune component. Participants will receive individualized
homoeopathic treatment based on classical homoeopathic principles, with prescriptions determined
through repertorization using RADAR software and standard materia medica references. Clinical
assessments—including SDAI scoring and laboratory investigations will be carried out at baseline and
every three months during a 12-month intervention period, with a total study duration of 18 months.
Data will be statistically analyzed using SPSS, with significance set at p lessthan 0.05. |