| CTRI Number |
CTRI/2025/03/081755 [Registered on: 06/03/2025] Trial Registered Prospectively |
| Last Modified On: |
05/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Role of homoeopathic medicines for lowering anti-CCP levels in rheumatoid arthritis |
|
Scientific Title of Study
|
A prospective clinical study to evaluate the role of individualized homoeopathic medicine on changes in anti- cyclic citrullinated peptide levels and clinical symptoms in patients with rheumatoid arthritis.
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sherin P James |
| Designation |
Postgraduate trainee |
| Affiliation |
National Institute of Homoeopathy |
| Address |
OPD room no:14, Department of Organon of Medicine, National Institute of Homoeopathy, GE Block, Sector 3, Salt lake, Kolkata 700106
WEST BENGAL
INDIA
Kolkata
WEST BENGAL
700106
India |
| Phone |
9746270251 |
| Fax |
|
| Email |
sherinpjames@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Indrani Chakrabarti |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Homoeopathy |
| Address |
OPD room no: 14, Department of Organon of Medicine, National Institute of Homoeopathy, GE Block, Sector 3, Salt lake, Kolkata 700106
WEST BENGAL
INDIA
Kolkata
WEST BENGAL
700106
India |
| Phone |
9433902555 |
| Fax |
|
| Email |
indrani.abc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Indrani Chakrabarti |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Homoeopathy |
| Address |
OPD room no: 14, Department of Organon of Medicine, National Institute Of Homoeopathy, GE Block, Sector 3, Salt lake, Kolkata 700106
WEST BENGAL
INDIA
Kolkata
WEST BENGAL
700106
India |
| Phone |
9433902555 |
| Fax |
|
| Email |
indrani.abc@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute Of Homoeopathy, GE Block, Sector 3,Salt Lake, Kolkata, West Bengal,700106,India |
|
|
Primary Sponsor
|
| Name |
National Institute of Homoeopathy |
| Address |
GE Block, Sector 3, Salt lake, Kolkata-700106
WEST BENGAL
INDIA |
| 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 SHERIN P JAMES |
National Institute Of Homoeopathy |
OPD ROOM NO 14,Department of Organon of Medicine,National Institute of Homoeopathy,GE Block, Sector 3,Salt lake,Kolkata 700106
WEST BENGAL
INDIA
Kolkata
WEST BENGAL |
9746270251
sherinpjames@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| National Institute Of Homoeopathy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M057||Rheumatoid arthritis with rheumatoid factor without organ or systems involvement, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualized Homoeopathic medicine in suitable potency |
All patients will be prescribed individualized homoeopathic medicine after detailed case taking in accordance with the directions given by Dr. C.F.S Hahnemann in Organon of Medicine 6th edition. Indicated individualized homoeopathic medicine in suitable potency will be prescribed. Dose and frequency of medicine will be decided as per homoeopathic principles. Follow up will be done monthly till 6 months from the baseline. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Cases fulfilling the diagnostic criteria of rheumatoid arthritis (ICD 10 M06.9) according to ACR OR ELAR score more than or equal to 6 out of 10
2.Cases with anti-CCP value above 20 IU per ml.
3.Patients in the age group of 18 to 65 years
4.Patients of all sexes, Religions and socio economic conditions
5.Patients who have not taken any treatment in the last 4 weeks for rheumatoid Arthritis
6.Patients who are willing to give written informed consent.
7.Patients who can read/ understand either English, Hindi, Bengali.
|
|
| ExclusionCriteria |
| Details |
1.Rheumatoid arthritis associated with complicated systemic diseases
2.Patients who are diagnosed with life threatening diseases, uncontrolled systemic illness, immune compromised states, psychiatric illness and malignancy
3.Patients not willing to undergo any investigation, if needed.
4.Patients on NSAIDs or DMARDs.
5.Pregnant women and lactating mothers.
6.Patients with substance abuse and or dependence
7.Patients who have been under homoeopathic treatment within in 3 months for any chronic illness.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| By measuring changes in Anti CCP levels |
At baseline and after 6 months of treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Disease Activity Score-28 (DAS-28) using ESR for Rheumatoid arthritis
|
At baseline and after 6 months of treatment |
|
|
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)
|
24/03/2025 |
| 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 Yet Recruiting |
| 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 systemic autoimmune disease characterized by inflammatory arthritis and extra-articular involvement. It is a chronic inflammatory disorder typically starts in small peripheral joints, is usually symmetric, and progresses to involve proximal joints and other joints if left untreated. Joint inflammation over time leads to the destruction of the joint with loss of cartilage and bone erosions. It is estimated to affect between 0.5 and 1.0% of the adult population worldwide. The disease is found to affect females more than the male population in the ratio 3:1. It is a multifactorial disease develops due to a combination of genetic and environmental factors. Patients with active RA also experience systemic inflammation associated with a variety of comorbidities, most importantly cardiovascular disease. Timely diagnosis and intervention are essential for preventing complications related to the disease, highlighting the need to identify diagnostic markers that can reliably predict the onset and progression of the condition. Timely diagnosis and intervention are essential for preventing complications related to the disease, highlighting the need to identify diagnostic markers that can reliably predict the onset and progression of the condition. Anti citrullinated protein antibodies (Anti CCP) are autoantibodies that are directed against peptides and proteins that are citrullinated. The detection of anti-cyclic citrullinated peptide (CCP) has emerged as a significant biomarker for the diagnosis of rheumatoid arthritis (RA). This assay exhibits a sensitivity comparable to that of rheumatoid factor (RF), yet it demonstrates superior specificity. Levels of anti CCP serves as a crucial serological marker for RA diagnosis, facilitating early detection, differentiation from other Rheumatoid arthritis forms, and prognostic assessment. An Individualized homoeopathic medicine based on totality of symptoms which include patient’s mental and physical sphere works holistically improving the mental sphere and improve physical signs and symptoms that are evident in homoeopathic cures. A Prospective, Nonrandomized, Open label, Single arm, Clinical Study with a sample size of 38 patients having Rheumatoid arthritis satisfying inclusion and exclusion criteria shall be enrolled for the study. Primary objective is to to find out whether Homoeopathic medicines are useful in changing the levels of Anti-CCP in rheumatoid arthritis at baseline and after a period of 6 months of intervention with individualized Homoeopathic medicines. Secondary objective is to evaluate effect of Homoeopathic medicines using Disease Activity Score 28 (DAS 28) for Rheumatoid arthritis before and after a period of 6 months of intervention. The usual follow up will be done at the interval of 4 weeks and will be recorded in follow up sheets. The descriptive data will be recorded in terms of absolute values, percentage etc. as appropriate. The final outcome will be analyzed as per appropriate statistical methods and inference will be done thereafter. The result will be published in scientific journals. |