A Clinical study to assess the efficacy and safety of Arthoplus in Patients with Rheumatoid Arthritis (RA).

Phase 3

Conditions: Health Condition 1: M058- Other rheumatoid arthritis with rheumatoid factor

Registration Number: CTRI/2023/10/058979

Lead Sponsor: Valyou Products Private Limited

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1.Male and female participants aged over 18 years old with a DAS28_ESR score greater than 2.6.

2.Participants have been diagnosed with RA by a general practitioner and/or orthopedic physician/surgeon according to the 2010 American College of Rheumatology 168 (ACR).

3.Able to evaluate disease activity by themselves.

4.Participants who have no plans to start new treatments during the study period

5.Patients who require anti-inflammatory treatment, do not use anti-inflammatory/analgesic medications on a regular basis, or are unsatisfied with their treatments and want to alter them.

6.Patients ready to give written informed consent and willing to comply the study protocol.

Exclusion Criteria

1. Participants using other complementary and alternative medicine or any addiction to psychotropic agents and opioids.

2. Participants with RA, septic arthritis, during the past 3 months.

3. Participants with uncontrolled medical conditions such as diabetes, uncontrolled hypertension, cardiovascular disease, gallbladder disease, renal disease, endocrine disease, or malignancies, neurological diseases, or psychiatric conditions.

4. Patients with concurrent rheumatoid diseases and gout. Use of biologic agent therapy in the last 6 months.

5. Participation in any other clinical trial within 30 days of screening.

6. Any history of allergy to any of the drugs/investigational products.

7. Pregnant and lactating women and women of childbearing age who do not follow adequate contraceptive measures.