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Homoeopathic treatment of joint pain in adults

A double-blind, randomized, placebo-controlled trial of individualized homoeopathic medicines in improving pain of rheumatoid arthritis in adults

Status
Recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/03/050893
Enrollment
51
Registered
2023-03-20
Start date
Unknown
Completion date
Unknown
Last updated
2023-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: M069- Rheumatoid arthritis, unspecified

Interventions

Sponsors

D N De Homoeopathic Medical College and Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
DAS-28 ESR ScoreTimepoint: At baseline, and after 3 months

Secondary

MeasureTime frame
Clinical disease activity index (CDAI) and simple disease activity index (SDAI)Timepoint: At baseline, and after 3 months;DAS-28 CRPTimepoint: At baseline, and after 3 months;Measure Yourself Medical Outcome Profile (MYMOP-2)Timepoint: At baseline, every month, up to 3 months

Countries

India

Contacts

Public ContactMd Sakhawat Hossain

D N De Homoeopathic Medical College and Hospital

imdrmsh@gmail.com9433852961

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026