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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03141125

Enrollment

Registered

2017-05-04

Start date

2016-01-31

Completion date

2017-08-31

Last updated

2017-08-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Scleroderma

Keywords

Erythrocyte sedimentation rate, Modified Rodnan Skin Score, B-cell Activating Factor, soluble-CD40Ligand, Procollagen Type-1 N-terminal Propeptide, Scleroderma

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

Interventions

OTHERPhysalis angulata ethanol extract

Ethanol extract of physalis angulate Linn with dosage of 3x250 mg/day given orally for 3 months

OTHERPlacebo

No active component at the same dosage of 3x250 mg/day given orally for 3 months

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

Double blind randomized placebo controlled trial

Intervention model description

Physalis angulata Linn. ethanol extract 3 x 250 mg

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Degree of skin fibrosis based on modified Rodnan Skin Score (mRSS)	3 months of intervention	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.

Secondary

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

Countries

Indonesia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026