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

University of Indonesia (UI)

Status: Completed

Conditions: Scleroderma

Treatments: Other: Physalis angulata ethanol extract; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03141125

UI-PAL/CCD-SSc.2016

Details and patient eligibility

About

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

Full 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

Enrollment: 62 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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62 participants in 2 patient groups, including a placebo group

Physalis angulata ethanol extract

Experimental group

Description:

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.

Treatment:

Other: Physalis angulata ethanol extract

Placebo

Placebo Comparator group

Description:

Patients received standard therapy and placebo (amylum powder) for comparator at dosage 3 x 250 mg/day, orally, for 3 months.

Treatment:

Other: Placebo