Clinical trial NCT03141125: The Effect of Ethanol Extract Physalis Angulata Linn. in Scleroderma Patients With Standard Therapy
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Scleroderma
Keywords: Erythrocyte sedimentation rate
Modified Rodnan Skin Score
B-cell Activating Factor
soluble-CD40Ligand
Procollagen Type-1 N-terminal Propeptide
Scleroderma
Lead sponsor: Indonesia University
Sponsor class: OTHER
Collaborators: name: Netherlands: Ministry of Health, Welfare and Sports
First posted: 2017-05-04
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Physalis angulata Linn. ethanol extract 3 x 250 mg
Primary purpose: TREATMENT

Brief summary: 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: 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

Eligibility criteria: Inclusion Criteria:

1. Patients who meet the criteria of the type of limited scleroderma diagnosis / limited or diffuse type.
2. 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.
3. The research subjects aged 15 to 60 years.
4. Subjects with modified Rodnan Skin score ≥ 5.
5. Disease duration ≥ 1 year

Exclusion Criteria:

1. Impaired liver function with cirrhosis
2. Chronic Renal dysfunction (chronic kidney disease stages 4-5). Or creatinine levels\> 2 mg / dL in the last 1 month prior to randomization.
3. Other autoimmune disease/overlap syndrome.
4. Received a steroid/prednisone \>10 mg/day in the last 1 month.
5. Patients who are pregnant or breastfeeding.
6. Patients with active tuberculosis and or are being treated with anti-tuberculosis medicines.
7. Severe heart disease. (Heart Disease with impaired function according to the New York Heart Association Class III or IV)
8. History of allergies to herbal Ciplukan / Physalis angulate Linn. or a history of hypersensitivity to certain drugs.
9. Hypotension (BP \<90/60 mmHg)
10. Hypoglycemia (Glucose level \<70 mg / dL)
11. Do not want to participate in the study

Primary outcomes:
measure: Degree of skin fibrosis based on modified Rodnan Skin Score (mRSS)
timeFrame: 3 months of intervention
Secondary outcomes:
measure: Level of P1NP serum
timeFrame: 3 months of intervention
measure: Value of ESR
timeFrame: 3 months of intervention
measure: Level of BAFF serum
timeFrame: 3 months of intervention
measure: Level of sCD40L serum
timeFrame: 3 months of intervention
Other outcomes:
Locations:
city: Bandung
country: Indonesia
facility: Hasan Sadikin Hospital
state: West Java
city: Jakarta
country: Indonesia
facility: Ciptomangunkusumo Hospital
Study officials:
affiliation: Department of Internal Medicine
name: Harry Isbagio, MD, Prof.
role: STUDY_CHAIR
References: