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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
62
Ethanol extract of physalis angulate Linn with dosage of 3x250 mg/day given orally for 3 months
No active component at the same dosage of 3x250 mg/day given orally for 3 months
Hasan Sadikin Hospital
Bandung, West Java, Indonesia
Ciptomangunkusumo Hospital
Jakarta, Indonesia
Degree of skin fibrosis based on modified Rodnan Skin Score (mRSS)
Clinical improvement of skin fibrosis in scleroderma patients measured by modified Improvement in skin fibrosis is defined if there is a significant reduced of mRSS.
Time frame: 3 months of intervention
Level of P1NP serum
Improvement is defined if there is a significant reduced of P1NP serum level
Time frame: 3 months of intervention
Value of ESR
Improvement is defined if there is a significant reduced of ESR value
Time frame: 3 months of intervention
Level of BAFF serum
Improvement is defined if there is a significant reduced of BAFF serum level
Time frame: 3 months of intervention
Level of sCD40L serum
Improvement is defined if there is a significant reduced of sCD40L serum level.
Time frame: 3 months of intervention
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