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

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

Study Overview

• Status: Completed
• Conditions: Scleroderma
• Intervention / Treatment: Other: Physalis angulata ethanol extract; Other: Placebo

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

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Indonesia
  • Jakarta, Indonesia, 10430
    • Ciptomangunkusumo Hospital
  • West Java
    • Bandung, West Java, Indonesia, 40161
      • Hasan Sadikin Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Physalis angulata ethanol extract; 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; Ethanol extract of physalis angulate Linn with dosage of 3x250 mg/day given orally for 3 months; Other Names: Herba Ciplukan; Ethanol extract of Physalis angulata Linn; Ethanol extract of Physalis angulata
PLACEBO_COMPARATOR: Placebo; Patients received standard therapy and placebo (amylum powder) for comparator at dosage 3 x 250 mg/day, orally, for 3 months.	Other: Placebo; No active component at the same dosage of 3x250 mg/day given orally for 3 months; Other Names: Amylum

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Indonesia University
• Collaborators: Netherlands: Ministry of Health, Welfare and Sports
• Investigators: Study Chair: Harry Isbagio, MD, Prof., Department of Internal Medicine

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2016
• Primary Completion (ACTUAL): August 1, 2017
• Study Completion (ACTUAL): August 1, 2017

Study Registration Dates

• First Submitted: June 20, 2016
• First Submitted That Met QC Criteria: May 3, 2017
• First Posted (ACTUAL): May 4, 2017

Study Record Updates

• Last Update Posted (ACTUAL): August 29, 2017
• Last Update Submitted That Met QC Criteria: August 27, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: Scleroderma; Erythrocyte sedimentation rate; Modified Rodnan Skin Score; B-cell Activating Factor; soluble-CD40Ligand; Procollagen Type-1 N-terminal Propeptide
• Additional Relevant MeSH Terms: Skin Diseases; Connective Tissue Diseases; Scleroderma, Systemic; Scleroderma, Diffuse; Scleroderma, Localized; Physiological Effects of Drugs; Anti-Infective Agents, Local; Anti-Infective Agents; Central Nervous System Depressants; Ethanol
• Other Study ID Numbers: UI-PAL/CCD-SSc.2016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO