The Effect of Ethanol Extract Physalis Angulata Linn. in Scleroderma Patients With Standard Therapy

Study Overview
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Brief Summary
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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

Detailed Description
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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

Official Title
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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

Conditions
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Scleroderma

Intervention / Treatment
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* Other: Physalis angulata ethanol extract
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who meet the criteria of the type of limited scleroderma diagnosis / limited or diffuse type. Patients who routine control in rheumatology outpatient clinics in Ciptomangunkusumo hospital Jakarta and Hasan Sadikin hospital Bandung RSHS who received standard therapy for scleroderma with a stable dose over the past 3 months. The research subjects aged 15 to 60 years. Subjects with modified Rodnan Skin score ≥ 5. Disease duration ≥ 1 year Exclusion Criteria: Impaired liver function with cirrhosis Chronic Renal dysfunction (chronic kidney disease stages 4-5). Or creatinine levels> 2 mg / dL in the last 1 month prior to randomization. Other autoimmune disease/overlap syndrome. Received a steroid/prednisone >10 mg/day in the last 1 month. Patients who are pregnant or breastfeeding. Patients with active tuberculosis and or are being treated with anti-tuberculosis medicines. Severe heart disease. (Heart Disease with impaired function according to the New York Heart Association Class III or IV) History of allergies to herbal Ciplukan / Physalis angulate Linn. or a history of hypersensitivity to certain drugs. Hypotension (BP <90/60 mmHg) Hypoglycemia (Glucose level <70 mg / dL) Do not want to participate in the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Physalis angulata Linn. ethanol extract 3 x 250 mg
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Physalis angulata ethanol extract<br>Physalis angulata ethanol extract was given with dosage 3 x 250 mg/day, orally, for 3 months. In addition, patients also received standard therapy for scleroderma. | Other: Physalis angulata ethanol extract<br>* Ethanol extract of physalis angulate Linn with dosage of 3x250 mg/day given orally for 3 months<br>* Other names: Ethanol extract of Physalis angulata;|
| Placebo Comparator: Placebo<br>Patients received standard therapy and placebo (amylum powder) for comparator at dosage 3 x 250 mg/day, orally, for 3 months. | Other: Placebo<br>* No active component at the same dosage of 3x250 mg/day given orally for 3 months<br>* Other names: Amylum;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 3 months of intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of P1NP serum | Improvement is defined if there is a significant reduced of P1NP serum level | 3 months of intervention | 
| Value of ESR | Improvement is defined if there is a significant reduced of ESR value | 3 months of intervention | 
| Level of BAFF serum | Improvement is defined if there is a significant reduced of BAFF serum level | 3 months of intervention | 
| Level of sCD40L serum | Improvement is defined if there is a significant reduced of sCD40L serum level. | 3 months of intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Erythrocyte sedimentation rate, Modified Rodnan Skin Score, B-cell Activating Factor, soluble-CD40Ligand, Procollagen Type-1 N-terminal Propeptide, Scleroderma