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

Scleroderma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03141125
• Other study ID #: UI-PAL/CCD-SSc.2016
• Status: Completed
• Phase: N/A
• First received: June 20, 2016
• Last updated: August 27, 2017
• Start date: January 2016
• Est. completion date: August 2017

Study information

• Verified date: August 2017
• Source: Indonesia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: August 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Scleroderma
• Scleroderma, Diffuse
• Scleroderma, Localized
• Scleroderma, Systemic

Intervention

Other:
• Physalis angulata ethanol extract
Ethanol extract of physalis angulate Linn with dosage of 3x250 mg/day given orally for 3 months
• Placebo
No active component at the same dosage of 3x250 mg/day given orally for 3 months

Locations

Country	Name	City	State
Indonesia	Hasan Sadikin Hospital	Bandung	West Java
Indonesia	Ciptomangunkusumo Hospital	Jakarta

Sponsors (2)

Lead Sponsor	Collaborator
Indonesia University	Netherlands: Ministry of Health, Welfare and Sports

Country where clinical trial is conducted

Indonesia, 

Outcome

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