The Effect of Ethanol Extract Physalis Angulata Linn. in Scleroderma Patients With Standard Therapy
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|ClinicalTrials.gov Identifier: NCT03141125|
Recruitment Status : Completed
First Posted : May 4, 2017
Last Update Posted : August 29, 2017
|Condition or disease||Intervention/treatment||Phase|
|Scleroderma||Other: Physalis angulata ethanol extract Other: Placebo||Not Applicable|
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.
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
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 (Clinical Trial)|
|Actual Enrollment :||62 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Physalis angulata Linn. ethanol extract 3 x 250 mg|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Masking Description:||Double blind randomized placebo controlled 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|
|Actual Study Start Date :||January 2016|
|Actual Primary Completion Date :||August 2017|
|Actual Study Completion Date :||August 2017|
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
Placebo Comparator: Placebo
Patients received standard therapy and placebo (amylum powder) for comparator at dosage 3 x 250 mg/day, orally, for 3 months.
No active component at the same dosage of 3x250 mg/day given orally for 3 months
Other Name: Amylum
- Degree of skin fibrosis based on modified Rodnan Skin Score (mRSS) [ Time Frame: 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.
- Level of P1NP serum [ Time Frame: 3 months of intervention ]Improvement is defined if there is a significant reduced of P1NP serum level
- Value of ESR [ Time Frame: 3 months of intervention ]Improvement is defined if there is a significant reduced of ESR value
- Level of BAFF serum [ Time Frame: 3 months of intervention ]Improvement is defined if there is a significant reduced of BAFF serum level
- Level of sCD40L serum [ Time Frame: 3 months of intervention ]Improvement is defined if there is a significant reduced of sCD40L serum level.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03141125
|Hasan Sadikin Hospital|
|Bandung, West Java, Indonesia, 40161|
|Jakarta, Indonesia, 10430|
|Study Chair:||Harry Isbagio, MD, Prof.||Department of Internal Medicine|