| CTRI Number |
CTRI/2025/09/094672 [Registered on: 12/09/2025] Trial Registered Prospectively |
| Last Modified On: |
11/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Role of Homoeopathy in Management of Rheumatoid arthritis |
|
Scientific Title of Study
|
Efficacy of individualized homoeopathic intervention versus specific homoeopathic intervention using Guaiacum officinale in centesimal scale in reducing rheumatoid factor levels in patients of rheumatoid arthritis: A single-blind randomized controlled trial. |
| 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 Abhishek Kumar singh |
| Designation |
Junior Resident |
| Affiliation |
Institute |
| Address |
Nehru Homoeopathic Medical College and Hospital , Defence Colony,B block
Department of Practice of Medicine , Nehru Homoeopathic Medical College and Hospital ,Defence Colony, B block ,New Delhi
South
DELHI
110024
India |
| Phone |
7903602529 |
| Fax |
|
| Email |
abhisheksenger486@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mohit Mathur |
| Designation |
Professor (Practice of Medicine) |
| Affiliation |
Nehru Homoeopathic Medical College And Hospital |
| Address |
Nehru Homoeopathic Medical College and Hospital ,New Delhi
Department of Practice of Medicine , Nehru Homoeopathic Medical College and Hospital
South
DELHI
110024
India |
| Phone |
9818449588 |
| Fax |
|
| Email |
drmohitmathur@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Abhishek Kumar singh |
| Designation |
Junior Resident |
| Affiliation |
Institute |
| Address |
Nehru Homoeopathic Medical College and Hospital
Department of Practice of Medicine , Nehru Homoeopathic Medical College and Hospital,New Delhi
South
DELHI
110024
India |
| Phone |
7903602529 |
| Fax |
|
| Email |
abhisheksenger486@gmail.com |
|
|
Source of Monetary or Material Support
|
| Nehru Homoeopathic Medical College And Hospital , Defence Colony,B block,New Delhi,110024 |
|
|
Primary Sponsor
|
| Name |
Nehru Homoeopathic Medical College And Hospital , Defence Colony B block ,New Delhi |
| Address |
Department of Practice of Medicine , Nehru Homoeopathic Medical College and Hospital ,Defence Colony, B block ,New Delhi |
| Type of Sponsor |
Government 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 Abhishek kumar Singh |
Nehru Homoeopathic Medical College and Hospital |
Opd 13,Rheumatoid Arthritis Project,Nehru Homoeopathic Medical College and Hospital,Defence Colony B Block,New Delhi
South
DELHI |
7903602529
abhisheksenger486@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institutional Ethics committee-NHMC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M058||Other rheumatoid arthritis with rheumatoid factor, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Guaiacum officinale in centesimal scale |
The Comparator arm will consist of patients randomized to receive Guaiacum officinale in centesimal potency.This remedy is one of the most commonly indicated medicines for Rheumatoid Arthritis in homeopathy.It is used here as a standardized control intervention against individualized prescriptions.The potency and repetition will be decided as per patients symptoms severity,susceptibility.Each dose will be consist of 4 medicated globules administered orally.Follow ups will be scheduled every 2 weeks or as per need of the case.Duration of this Study will be for 1 Years. |
| Intervention |
Individualized Homoeopathic Medicine |
Individualized Homoeopathic Medicines will be Prescribed Based on Detailed Case taking, Symptom Totality Formation, and Repertorization using appropriate repertories. A single remedy will be selected according to homoeopathic principles and administered in the centesimal scale. Potency and repetition will be individualized depending on the patient symptom severity susceptibility. Each dose will consist of 4 medicated globules administered orally, either as a single or repeated dose according to clinical response. Follow-ups will be scheduled every 2 weeks or as per the need of the case. Duration of Study will be for 1 Year. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Age between 18–65 years.
2.Cases of Both sexes.
3.Diagnosed with RA as per 2010 ACR or EULAR criteria.
4.Positive Rheumatoid Factor at baseline.
5.Disease duration more than 6 weeks.
6.Patient willing to participate voluntarily and provide written informed consent.
|
|
| ExclusionCriteria |
| Details |
1.Patients with other severe systemic illnesses, malignant disorders, autoimmune diseases or any organic disease.
2.Patients on long-term corticosteroids or immunosuppressants. Any major surgery in the last 6 months.
3.Patients under other medication from past 2-3 months for the same complaint.
4.Unexplained weight loss.
5.RA with severe joint deformities or contractures.
6.Patients with cognitive impairment.
7.Pregnant women and lactating mothers.
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Rheumatoid Factor levels |
Rheumatoid Factor levels will be evaluated at baseline and at 12 weeks interval |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Disease Activity Score 28 (DAS 28) |
DAS 28 Score will be evaluated at baseline and at 12 weeks interval |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
13/10/2025 |
| 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="0"
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 study is a single-blind randomized controlled trial comparing the efficacy of individualized homoeopathic treatment versus specific homoeopathic intervention with Guaiacum officinale (centesimal scale) in patients with Rheumatoid Arthritis (RA). RA is a chronic autoimmune disease affecting 0.5–1% of the population, more common in women, and often associated with elevated Rheumatoid Factor (RF) levels, which predict severe disease. A total of 60 patients (30 in each group) will be enrolled and treated for 12 weeks. The primary outcome is reduction in RF levels, while secondary outcomes include improvement in disease activity using DAS28 score and clinical symptom relief. Patients in the experimental arm will receive individualized remedies based on totality of symptoms, while the comparator arm will receive Guaiacum officinale. Statistical analysis will assess within- and between-group differences. The trial seeks to establish whether individualized homeopathy offers superior benefits over a fixed specific remedy in RA management |