Aceclofenac and diacerein combination treatment for arthritis

Efficacy and tolerance of aceclofenac and diacerein combination for inflammatory osteoarthritis

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN74554616

Enrollment

384

Registered

2018-08-22

Start date

2019-09-01

Completion date

Unknown

Last updated

2020-04-27

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

Conditions

Inflammatory osteoarthritis Musculoskeletal Diseases Inflammatory osteoarthritis of the knee

Interventions

Patient will be allocated into 2 groups - the intervention group and the control group. Patients in the intervention group will be treated with Aceclofenac and diacerein. Aceclofenac w

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Aged 18 years or older 2. Knee pain that worsens on activity and is relieved with rest 3. Early morning pain 4. Reduced medial joint space on AP view X-ray of the knee 5. Knee effusion

Exclusion criteria

Exclusion criteria: 1. Psychiatric patient 2. Pregnant 3. Breastfeeding 4. No informed consent

Design outcomes

Primary

Measure	Time frame
1. Improvement in pain, assessed using the Visual Analog Scale at 3, 6, 9 and 12 months after beginning treatment, along with every 3 months throughout the 1 year follow-up period 2. Gastrointestinal toxicity of a tapering dose of Aceclofenac and diacerein, assessed at at 3, 6, 9 and 12 months after beginning treatment using: 2.1. Patient history of nausea, vomiting, anorexia, dyspepsia, abdominal pain 2.2. Liver function tests, including tests for bilirubin, aspartate transaminase (SGOT), alanine transaminase (SGPT) and alkaline phosphatase (ALP) 3. Renal toxicity of a tapering dose of Aceclofenac and diacerein, assessed at at 3, 6, 9 and 12 months after beginning treatment using: 3.1. Renal function tests, including tests for urea and creatinine 3.2. Urine r/m/e test (complete urine examination)	—

Measure

Time frame

1. Improvement in pain, assessed using the Visual Analog Scale at 3, 6, 9 and 12 months after beginning treatment, along with every 3 months throughout the 1 year follow-up period 2. Gastrointestinal toxicity of a tapering dose of Aceclofenac and diacerein, assessed at at 3, 6, 9 and 12 months after beginning treatment using: 2.1. Patient history of nausea, vomiting, anorexia, dyspepsia, abdominal pain 2.2. Liver function tests, including tests for bilirubin, aspartate transaminase (SGOT), alanine transaminase (SGPT) and alkaline phosphatase (ALP) 3. Renal toxicity of a tapering dose of Aceclofenac and diacerein, assessed at at 3, 6, 9 and 12 months after beginning treatment using: 3.1. Renal function tests, including tests for urea and creatinine 3.2. Urine r/m/e test (complete urine examination)

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Secondary

Measure	Time frame
1. Long-term effects of diacerein alone over 1 year, assessed by: 1.1. Visual Analogue Score (VAS) for pain, at 3, 6, 9 and 12 months after beginning treatment, along with every 3 months throughout the 1 year follow-up period 1.2. Western Ontario & McMaster Universities Osteoarthritis Index (WOMAC) score at 3, 6, 9 and 12 months after beginning treatment, along with every 3 months throughout the 1 year follow-up period 1.3. Kellgren-Lawrence Classification of Osteoarthritis (KL grading), determined from an X-ray taken 12 months after beginning treatment and at the end of the 1 year follow-up period 2. Change and maintenance of functional status of patients, assessed using the Western Ontario & McMaster Universities Osteoarthritis (WOMAC) score at 3, 6, 9 and 12 months after beginning treatment 3. Change in physical disability, assessed using the Health Assessment Questionnaire (HAQ) at 3, 6, 9 and 12 months after beginning treatment 4. Change in radiographic findings over 1 year, assessed using the Kellgren-Lawrence Classification of Osteoarthritis (KL grading), determined from an X-ray taken 12 months after beginning treatment	—

Measure

Time frame

1. Long-term effects of diacerein alone over 1 year, assessed by: 1.1. Visual Analogue Score (VAS) for pain, at 3, 6, 9 and 12 months after beginning treatment, along with every 3 months throughout the 1 year follow-up period 1.2. Western Ontario & McMaster Universities Osteoarthritis Index (WOMAC) score at 3, 6, 9 and 12 months after beginning treatment, along with every 3 months throughout the 1 year follow-up period 1.3. Kellgren-Lawrence Classification of Osteoarthritis (KL grading), determined from an X-ray taken 12 months after beginning treatment and at the end of the 1 year follow-up period 2. Change and maintenance of functional status of patients, assessed using the Western Ontario & McMaster Universities Osteoarthritis (WOMAC) score at 3, 6, 9 and 12 months after beginning treatment 3. Change in physical disability, assessed using the Health Assessment Questionnaire (HAQ) at 3, 6, 9 and 12 months after beginning treatment 4. Change in radiographic findings over 1 year, assessed using the Kellgren-Lawrence Classification of Osteoarthritis (KL grading), determined from an X-ray taken 12 months after beginning treatment

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Countries

Nepal

Contacts

Public ContactBinit;Bibhuti Vaidya;Upreti

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Outcome results

None listed

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