Clinical Efficacy of Glucosamine Plus Diacerein Versus Mono-therapy of Glucosamine

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

148 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2014-10-31

Brief Summary

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The purpose of this study is to compare pain scores, WOMAC total and subscores, actual and change of joint space width and the rate of gastrointestinal side effects at 4, 8, 12, and 24 weeks between dual-therapy of diacerein and glucosamine versus a mono-therapy of glucosamine in OA patients

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Detailed Description

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Conditions

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Osteoarthritis Glucosamine Diacerein

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Glucosamine sulfate & Diacerein

Glucosamine sulfate (sachet) 1500 mg and Diacerein 50 mg tablet by mouth once daily for 24 weeks

Group Type EXPERIMENTAL

Glucosamine sulfate

Intervention Type DRUG

Diacerein

Intervention Type DRUG

Glucosamine sulfate & Placebo

Glucosamine sulfate 1500 mg and Placebo (for Diacerein) 50 mg by mouth once daily for 24 weeks

Group Type ACTIVE_COMPARATOR

Glucosamine sulfate

Intervention Type DRUG

Placebo (for Diacerein)

Intervention Type DRUG

Sugar pill manufactured to mimic Diacerein 50 mg tablet

Interventions

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Glucosamine sulfate

Intervention Type DRUG

Diacerein

Intervention Type DRUG

Placebo (for Diacerein)

Sugar pill manufactured to mimic Diacerein 50 mg tablet

Intervention Type DRUG

Other Intervention Names

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Viatril-S Artrodar

Eligibility Criteria

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Inclusion Criteria

* Clinical diagnosis of primary osteoarthritis
* Mild deformity Clinical (having no varus or valgus deformity, no crepitus) ? Physical examination grade 0 assessed by stress test Radiographic assessment (Kellgrane-lawrance type II-III), a minimum baseline medial tibiofemoral JSW of \_2 mm.
* Willing to participate and provide written informed consent

Exclusion Criteria

* Non-secondary osteoarthritis Rheumatoid arthritis, inflammatory arthritis (e.g. SLE, Gout), post traumatic osteoarthritis, those who received intra-articular treatment of the signal joint with any product (corticosteroids in the previous 2 months, or glycosaminoglycans/hyaluronic acid in the previous 6 months) or had undergone joint lavage andarthroscopic procedures in the previous 6 months.
* No contraindication of using diacerein and glucosamine
* Non-current or ex-users of oral SYSADOA (e.g., glucosamine sulphate, chondroitin sulphate, diacerein, piascledine), anti-depressants, tranquillisers, antacids or antibiotics known hypersensitivity to diacerein, to similar compounds, to the excipients or to paracetamol

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No