| CTRI Number |
CTRI/2023/03/050893 [Registered on: 20/03/2023] Trial Registered Prospectively |
| Last Modified On: |
20/03/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Homoeopathic treatment of joint pain in adults |
|
Scientific Title of Study
|
A double-blind, randomized, placebo-controlled trial of individualized homoeopathic medicines in improving pain of rheumatoid arthritis in adults |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1288-8168 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Chayan Panja |
| Designation |
Postgraduate Trainee |
| Affiliation |
D N De Homoeopathic Medical College and Hospital |
| Address |
Dept. of Materia Medica, OPD no. PG2 and room no. 1 (Medicine),
12, Gobinda Khatick Road, Tangra, Kolkata
Kolkata
WEST BENGAL
700046
India |
| Phone |
6291350019 |
| Fax |
|
| Email |
chayanpanja3500@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Md Sakhawat Hossain |
| Designation |
Professor and Head |
| Affiliation |
D N De Homoeopathic Medical College and Hospital |
| Address |
Dept. of Materia Medica, OPD no. PG2 and room no. 1 (Medicine),
12, Gobinda Khatick Road, Tangra, Kolkata
Kolkata
WEST BENGAL
700046
India |
| Phone |
9433852961 |
| Fax |
|
| Email |
imdrmsh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Md Sakhawat Hossain |
| Designation |
Professor and Head |
| Affiliation |
D N De Homoeopathic Medical College and Hospital |
| Address |
Dept. of Materia Medica, OPD no. PG2 and room no. 1 (Medicine),
12, Gobinda Khatick Road, Tangra, Kolkata
Kolkata
WEST BENGAL
700046
India |
| Phone |
9433852961 |
| Fax |
|
| Email |
imdrmsh@gmail.com |
|
|
Source of Monetary or Material Support
|
| D N De Homoeopathic Medical College and Hospital, 12, Gobinda Khatick Road, Tangra, Kolkata 700046 |
|
|
Primary Sponsor
|
| Name |
D N De Homoeopathic Medical College and Hospital |
| Address |
12, Gobinda Khatick Road, Tangra, Kolkata 700046, West Bengal |
| 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 |
| Chayan Panja |
D N De Homoeopathic Medical College and Hospital |
OPD no. PG2 and room no.1 (Medicine), Dept of Mteria Medica, 12, Gobinda Khatick Road, Tangra
Kolkata
WEST BENGAL |
6291350019
chayanpanja3500@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M069||Rheumatoid arthritis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Identical-looking placebos plus concomitant care |
This group will receive placebo, identical in appearance with the verum. Each dose will consist of 4 cane sugar globules no. 40 moistened with 90% v/v ethanol, to be taken orally on clean tongue with empty stomach; dosage and repetition will be maintained depending upon the individual requirement of the cases. All sundry items will be procured from a Good Manufacturing Practice (GMP) certified firm. All the enrolled patients will receive advices on general management i.e. adequate rest, physical activity, exercise and proper dietary management. Duration of the study: 3 months. |
| Intervention |
Individualized homoeopathic medicines in centesimal potencies plus concomitant care |
Intervention is planned as administering indicated homoeopathic medicines in centesimal potencies (CH). Each dose will consist of 4 cane sugar globules no. 40 moistened with the indicated medicine (preserved in 90% v/v ethanol), to be taken orally on clean tongue with empty stomach; dosage and repetition depending upon the individual requirement of the cases. Patients will be advised to refrain from handling the globules or from eating, drinking, smoking or brushing teeth within 30 minutes of taking the globules and will be asked to suck the globules rather than simply swallowing those. All the medicines and sundry items will be procured from a Good Manufacturing Practice (GMP) certified firm. All the enrolled patients will receive advices on general management i.e. adequate rest, physical activity, exercise and proper dietary management. Duration of the study: 3 months. |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients suffering from rheumatoid arthritis (M06.9) for 3 months or more, diagnosis confirmed through the criteria given by the 2010 American College of Rheumatology and European League Against Rheumatism (ACR/EULAR)
Number and site of involved joints -
2 to 10 large joints: 1 point (shoulders, elbows, hips, knees, and ankles)
1 to 3 small joints: 2 points (metacarpophalangeal joints, proximal interphalangeal joints, second through fifth metatarsophalangeal joints, thumb interphalangeal joints, and wrists)
4 to 10 small joints: 3 points
Greater than 10 joints (including at least 1 small joint): 5 points
Serological testing for rheumatoid factor[RA] or anti-citrullinated peptide/protein antibody [ACPA] at least one test is needed for classification
Low positive: 2 points
High positive: 3 points
Acute phase reactants (at least one test result is needed for classification)
Negative erythrocyte sedimentation rate [ESR] and C-reactive protein [CRP]: 0 point
Elevated acute phase reactant [ESR] or C-reactive protein [CRP]:1 point
Symptom duration at least six weeks: 1 point.
A total score of greater than or equal to 6 classifies the patient as having RA.
2. DAS-28 ESR score between 2.6 and less than 3.2 (low disease activity) and between 3.2 and 5.1 (moderate disease activity).
3. Age between 18 and 65 years
4. Patients of either sex including transgender, if any.
5. Literate patients; ability to read English and/or Bengali, hindi, Illiterate people will be interviewed by the investigators maintaining adequate privacy to fill up the scales or questionnaires.
6. Providing written informed consent voluntarily.
7. Patients with known but controlled systemic diseases are also eligible for the study.
|
|
| ExclusionCriteria |
| Details |
1. Cases with complication showing extra articular features like digital arteritis, pericarditis, cervical cord compression etc
2. Apparently Similar resembling disease conditions; e.g., idiopathic osteoarthritis, systemic lupus erythematosus, psoriatic arthritis.
3. Vulnerable population- unconscious, non-ambulatory, too sick for consultation, differently abled, terminally ill or critically ill patients, institutionalized subjects, mentally incompetent people.
4. Diagnosed cases of unstable mental or psychiatric illness or other uncontrolled or life-threatening illness affecting quality of life or any organ failure.
5. Pregnant and puerperal women, lactating mothers
6. Patient under tobacco chewing and/or smoking, alcoholism and/or any other form(s) of substance abuse and/or dependence
7. Self-reported immune-compromised state
8. Already undergoing homoeopathic treatment for chronic disease within last 6 months.
9. Simultaneous participation in any other trials |
|
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Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| DAS-28 ESR Score |
At baseline, and after 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| DAS-28 CRP |
At baseline, and after 3 months |
| Clinical disease activity index (CDAI) and simple disease activity index (SDAI) |
At baseline, and after 3 months |
| Measure Yourself Medical Outcome Profile (MYMOP-2) |
At baseline, every month, up to 3 months |
|
|
Target Sample Size
|
Total Sample Size="51"
Sample Size from India="51"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
03/04/2023 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
None, yet to be published |
|
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
Response - Analytic Code
- 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 - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [chayanpanja3500@gmail.com].
- For how long will this data be available start date provided 01-01-2026 and end date provided 31-12-2030?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
|
Brief Summary
|
Rheumatoid arthritis (RA) is a chronic inflammatory disease characterized by swelling of joints, joint tenderness and destruction of synovial joints, resulting in disability and untimely mortality. It is the most common inflammatory arthritis, affecting from 0.8% to 1% of the general population worldwide, with a female/male ratio of 3:1. The most common and predominant symptoms include joint pain and morning stiffness along with swelling. RA primarily involves small peripheral joints, usually of the hands. Axial joint involvement, is seen especially of the cervical region. We intend to undertake this research project to evaluate the efficacy of homoeopathic medicines in the treatment of RA in adults. A double blind, randomized (2:1),placebo-controlled trial will be conducted on 51 patients who are suffering from RA at the outpatient department of D.N. De Homoeopathic Medical College and Hospital. Primary outcome measure is DAS-28 ESR score; secondary outcomes are DAS-28 CRP, CDAI, SDAI and MYMOP-2. DAS-28 ESR, DAS-28 CRP, CDAI and SDAI to be measured at baseline and after 3 months. MYMOP-2 will be measured at baseline, every month, up to 3 months. Comparative analyses will be carried out to detetct group differences. Results will be published in scientific journals. |