Scleroderma Clinical Trial
Official title:
The Effect of Ethanol Extract Physalis Angulata Linn. in Scleroderma Patients With Standard Therapy to Reduce Skin Fibrosis Based on Modified Rodnan Skin Score, Reduce Inflammation, Immunological Response and Fibrosis
Study about the effect of ethanol extract physalis angulate in scleroderma patients with standard therapy to reduce skin fibrosis based on modified Rodnan Skin Score, reduce inflammation, immunological response and fibrosis: A Randomized Clinical Placebo ControlledTrial with a prospective cohort study on scleroderma outpatient clinic in Cipto Mangunkusumo Hospital in Jakarta and Hasan Sadikin Hospital in Bandung, from January 2016 to July 2017
Background.
Scleroderma is a systemic autoimmune disease that can not be cured, the progression of the
disease still difficult to prevent and lead to increased morbidity and mortality.
Disease-modifying anti-rheumatic drugs (DMARDs) as standard immunosuppressant drugs to
reduce, eliminate, inhibit inflammation and fibrosis in scleroderma patient is still less
effective.
Objectives.
To evaluate the effect of ethanol extract of Physalis angulate Linn to reduce skin fibrosis
based on MRSS, ESR, BAFF, sCD40L, and P1NP in scleroderma patients with standard therapy
Methods.
A Randomized, Double-Blind, Placebo-Controlled Clinical Trial on scleroderma patients with
standard therapy, who admitted to Cipto Mangunkusumo Hospital Jakarta and Hasan Sadikin
Hospital Bandung, from January 2016 to July 2017.
Patients must be controlled every month until three months for follow up. Subjects were
divided into two parallel group, one of intervention group, and one of placebo group
;
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