Effectiveness of Unani formulation UNIM-301 in Rheumatoid arthritis

Evaluating the Efficacy and Safety of the Oral Polyherbal Drug Unani UNIM 301 as an Add On Therapy to Standard Care in Rheumatoid Arthritis A Randomized Controlled Trial - Nil

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/01/100245

Enrollment

244

Registered

2026-01-02

Start date

Unknown

Completion date

Unknown

Last updated

2026-01-12

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

Conditions

Health Condition 1: M057- Rheumatoid arthritis with rheumatoid factor without organ or systems involvement

Interventions

Intervention1: UNIM301: UNIM301 is a Unani coded polyherbal formulation, 2 tablets of UNIM-301 containing 500mg of active ingredients, orally thrice daily an hour after meals along with non-pharmacolo

Eligibility

Inclusion criteria

Inclusion criteria: 1. Trial Participants of either sex, aged 18-65 years 2. Trial Participants with definite rheumatoid arthritis fulfilling the ACR/EULAR 2010 criteria. 3. Disease duration less than 5 years since persistent arthritis 4. Trial Participants having at least one swollen or tender joint 5. Trial Participants with DAS28 score more than 3.2 %

Exclusion criteria

Exclusion criteria: 1. Pregnant and nursing patients 2. Trial Participants with severe anemia Hb level less than 13 g per dL in men; less than 12 g per dL in women 3. Trial Participants on corticosteroid therapy in the past 3 month 4. Trial Participants on biological therapy 5. Trial Participants resistant to treatment with more than three traditional DMARD s 6. Trial Participants those in remission or with low disease activity 7. Significant cardiac, pulmonary & hepato renal dysfunction 8. Known cases of Hepatitis B, Hepatitis C, HIV or malignancies 9. Trial Participants unsure about attending treatment schedule regularly 10. Trial Participants having Gout, or complicated RA 11. Abnormality at baseline investigation in SGOP, SGPT, ALP , S. Creatinine, B, Urea if raided more than 2.5 times the normal value 12. Trial Participants having GFR significantly lower than 60 mL per min. 13. Severe cases of RA Stage III & IV 14. Diagnosed cases of Ankylosing spondylosis

Design outcomes

Primary

Measure	Time frame
1.Measures of disease severity oACR-EULAR oDAS28CRP and DAS28ESR o Simlified Disease Activity Index 2.Mental health Quality of Life assessment oThe Health Assessment Questionnaire Disability Index 3.Laboratory Measures oTo confirm diagnosis & track response Rheumatoid Factor and Anti-Citrullinated Protein Antibody i.e.Anti cyclic Citrullinated Peptide Antibodies oInflammatory markers ESR, CRP oTo assess joint damage progression X-ray of affected joint 4.Safety and Adverse Event Monitoring oCBC oLFT oKFT Timepoint: 1.Measures of disease severity oACR-EULAR at screening, 0,4,8,12,16,28 week oDAS28CRP and DAS28ESR at screening, 0,4,8,12,16, 20,24,28 week o Simlified Disease Activity Index at 0,4,8,12,16, 20,24,28 week 2.Mental health Quality of Life assessment at 0,4,8,12,16, 20,24,28 week oThe Health Assessment Questionnaire Disability Index at 0,4,8,12,16, 20,24,28 week 3.Laboratory Measures oTo confirm diagnosis & track response Rheumatoid Factor and Anti-Citrullinated Protein Antibody i.e.Anti cyclic Citrullinated Peptide Antibodies 0, 16, 28 week oInflammatory markers ESR, CRP screening, 0,4,8,12,16, 20,24,28 week oTo assess joint damage progression X-ray of affected joint at 0, 24 week 4.Safety and Adverse Event Monitoring at 0,4,8,12,16, 28 week oCBC oLFT oKFT	—

Measure

Time frame

1.Measures of disease severity oACR-EULAR oDAS28CRP and DAS28ESR o Simlified Disease Activity Index 2.Mental health Quality of Life assessment oThe Health Assessment Questionnaire Disability Index 3.Laboratory Measures oTo confirm diagnosis & track response Rheumatoid Factor and Anti-Citrullinated Protein Antibody i.e.Anti cyclic Citrullinated Peptide Antibodies oInflammatory markers ESR, CRP oTo assess joint damage progression X-ray of affected joint 4.Safety and Adverse Event Monitoring oCBC oLFT oKFT Timepoint: 1.Measures of disease severity oACR-EULAR at screening, 0,4,8,12,16,28 week oDAS28CRP and DAS28ESR at screening, 0,4,8,12,16, 20,24,28 week o Simlified Disease Activity Index at 0,4,8,12,16, 20,24,28 week 2.Mental health Quality of Life assessment at 0,4,8,12,16, 20,24,28 week oThe Health Assessment Questionnaire Disability Index at 0,4,8,12,16, 20,24,28 week 3.Laboratory Measures oTo confirm diagnosis & track response Rheumatoid Factor and Anti-Citrullinated Protein Antibody i.e.Anti cyclic Citrullinated Peptide Antibodies 0, 16, 28 week oInflammatory markers ESR, CRP screening, 0,4,8,12,16, 20,24,28 week oTo assess joint damage progression X-ray of affected joint at 0, 24 week 4.Safety and Adverse Event Monitoring at 0,4,8,12,16, 28 week oCBC oLFT oKFT

—

Secondary

Measure	Time frame
nilTimepoint: nil	—

Countries

India

Contacts

Public ContactAbdul Raheem

CCRUM, MINISTRY OF AYUSH

drabdulraheemccrum@gmail.com9810919345

Outcome results

None listed

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