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To evaluate the safety and comparative efficacy of investigational product BioSOLVECurcuminTM in patients with active Rheumatoid Arthritis in Knee, Hand and Neck.

A randomized, double-blind, placebo-controlled parallel group study to evaluate the safety and comparative efficacy of investigational product BioSOLVECurcuminTM in patients with active Rheumatoid Arthritis in Knee, Hand and Neck.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/08/020535
Enrollment
24
Registered
2019-08-02
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: M249- Joint derangement, unspecified

Interventions

Intervention1: BioSOLVECurcuminTM: To be taken 2 capsules of 500 mg to be taken in morning before breakfast and at night after dinner per a day fro 12 weeks Control Intervention1: Placebo: To be taken

Sponsors

ZeusHygia LifeSciences Private Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients in the age group of 18-65 years, either male or female. 2.Diagnosis of RA according to the revised 2010 American College of Rheumatology (ACR) criteria (with RA functional class of II). Total number of the Swollen Joint Count (SJC) and Tender Joint Count (TJC) should be greater than 8. 3.Continuing or recurring pain (i.e joint pain daily, unless on pain medication). 4. Ability and willingness to participate in all components of the study 5. Patients who able to understand and sign written informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients to whom one of following applies will be excluded: dysfunction of liver; severe cardiovascular, urinary, hematopoietic, or endocrine system disease; immunodeficiency; uncontrolled infection or active gastrointestinal tract disease; recent vaccination; gravida; women in lactation period or those recently intending to become pregnant; hypersensitivity to study product; treatment with any other disease-modifying anti-rheumatic drug (DMARD) or NSAIDS within 30 days before enrolment; history of alcohol abuse; history of hyperglycemia or motor coordination disorder; or participation in other clinical trials within 3 months before enrolment. 2.Patients with any surgical procedure, including bone or joint surgery or synovectomy within 12 weeks prior to screening. 3.Patients with significant systemic involvement of secondary RA (including diseases such as vasculitis, pulmonary fibrosis or Feltys syndrome), inflammatory joint disease other than RA (e.g. gout, psoriatic arthritis, seronegative spondyloarthropathy and Lyme disease) 4. Subjects with other systemic autoimmune disorder (e.g. systemic lupus erythematosus, inflammatory bowel disease, scleroderma, inflammatory myopathy, overlap diseases

Design outcomes

Primary

MeasureTime frame
To assess the comparative efficacy of investigational product BioSOLVECurcuminTM by the assessment of ACR-20, WOMAC scale and VAS in patients with active rheumatoid arthritis in knees, hands and neck.Timepoint: Baseline Visit Day 1,Day 30,Day 60, End of Visit (Day 90)—

Secondary

MeasureTime frame
To assess the safety of investigational product BioSOLVECurcuminTM in active rheumatoid arthritis patients.Timepoint: Baseline Visit Day 1,Day 30,Day 60, End of Visit (Day 90)—

Countries

India

Contacts

Public ContactDivya C

BioAgile Therapeutics Private Limited

pm@bioagiletherapeutics.com08043754520

Outcome results

None listed

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