The Effect of Ethanol Extract Physalis Angulata Linn. in Scleroderma Patients With Standard Therapy
NCT ID: NCT03141125
Last Updated: 2017-08-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
62 participants
INTERVENTIONAL
2016-01-31
2017-08-31
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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.
Physalis angulata ethanol extract
Ethanol extract of physalis angulate Linn with dosage of 3x250 mg/day given orally for 3 months
Placebo
Patients received standard therapy and placebo (amylum powder) for comparator at dosage 3 x 250 mg/day, orally, for 3 months.
Placebo
No active component at the same dosage of 3x250 mg/day given orally for 3 months
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
60 Years
ALL
No
Sponsors
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Netherlands: Ministry of Health, Welfare and Sports
OTHER_GOV
Indonesia University
OTHER
Responsible Party
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Sumartini Dewi
MD, Master of Health
Principal Investigators
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Harry Isbagio, MD, Prof.
Role: STUDY_CHAIR
Department of Internal Medicine
Locations
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Hasan Sadikin Hospital
Bandung, West Java, Indonesia
Ciptomangunkusumo Hospital
Jakarta, , Indonesia
Countries
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Other Identifiers
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UI-PAL/CCD-SSc.2016
Identifier Type: -
Identifier Source: org_study_id
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