A Double-blind, Randomized Controlled Trial of Ciplukan (Physalis angulata Linn) Extract on Skin Fibrosis, Inflammatory, Immunology, and Fibrosis Biomarkers in Scleroderma Patients
Background: scleroderma is an autoimmune disease characterized by organ fibrosis, resistant to standard treatment. It is suspected the addition of Physalis angulata Linn. (Ciplukan) extract as adjuvant therapy can improve the scleroderma skin fibrosis. The aim at this study is to evaluate the effect...
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Interna Publishing
2020-02-01
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| Series: | Acta Medica Indonesiana |
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| Online Access: | https://actamedindones.org/index.php/ijim/article/view/1387 |
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| author | Sumartini Dewi Harry Isbagio Erni Hernawati Purwaningsih Nyoman Kertia Rianto Setiabudy Siti Setiati |
| author_facet | Sumartini Dewi Harry Isbagio Erni Hernawati Purwaningsih Nyoman Kertia Rianto Setiabudy Siti Setiati |
| author_sort | Sumartini Dewi |
| collection | DOAJ |
| description | Background: scleroderma is an autoimmune disease characterized by organ fibrosis, resistant to standard treatment. It is suspected the addition of Physalis angulata Linn. (Ciplukan) extract as adjuvant therapy can improve the scleroderma skin fibrosis. The aim at this study is to evaluate the effect of ciplukan extract as adjuvant on scleroderma skin fibrosis in standard therapy, based on modified Rodnan skin scale (MRSS), inflammatory biomarkers, immunology and serum fibrosis. Methods: double-blind, randomized clinical trial was performed in scleroderma patients with stable disease at Cipto Mangunkusumo hospital and Hasan Sadikin hospital during November 2015−March 2017 who met the selection criteria and continued to receive standard therapy. The subjects were randomly allocated into two groups: the study group received the ciplukan extract 3 x 250 mg / day for 12 weeks and the placebo group. Examination of MRSS, ESR, P1NP, BAFF and sCD40L was performed every 4 weeks until the end of the study. Results: fifty-nine subjects completed the study. They consisted of 29 subjects of the treatment group and 30 of the placebo group, with an average age of 41 (SD 9) years, the proportion of women: male = 9 : 1. There was a significant improvement of skin fibrosis in the study group with a highly significant decrease in MRSS (35.9% VS 6.3%, p <0.001) and a relative decrease in P1NP levels (17.8% VS 0.7%, p = 0.002). No decrease in ESR, BAFF and sCD40L levels in both groups. There was a weak but significant positive correlation between MRSS with P1NP levels (r = 0.236, p = 0.036). Conclusion: Ciplukan extract with dose 3 x 250 mg for 12 weeks as adjuvant on scleroderma standard therapy alleviates skin fibrosis significantly based on MRSS and P1NP levels.
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| format | Article |
| id | doaj-art-59b58f540fb845e080c8284f36733d6a |
| institution | DOAJ |
| issn | 0125-9326 2338-2732 |
| language | English |
| publishDate | 2020-02-01 |
| publisher | Interna Publishing |
| record_format | Article |
| series | Acta Medica Indonesiana |
| spelling | doaj-art-59b58f540fb845e080c8284f36733d6a2025-08-20T03:13:54ZengInterna PublishingActa Medica Indonesiana0125-93262338-27322020-02-01514342A Double-blind, Randomized Controlled Trial of Ciplukan (Physalis angulata Linn) Extract on Skin Fibrosis, Inflammatory, Immunology, and Fibrosis Biomarkers in Scleroderma PatientsSumartini Dewi0Harry Isbagio1Erni Hernawati Purwaningsih2Nyoman Kertia3Rianto Setiabudy4Siti Setiati5Department of Internal Medicine, Faculty of Medicine, Padjadjaran University - Hasan Sadikin Hospital, Bandung, IndonesiaDepartment of Internal Medicine, Faculty of Medicine Universitas Indonesia - Cipto Mangunkusumo Hospital, Jakarta, IndonesiaDepartment of Pharmacy, Universitas Indonesia, Jakarta, IndonesiaDepartment of Internal Medicine, Faculty of Medicine, University of Gadjah Mada, Yogyakarta, IndonesiaDepartment of Pharmacology, Universitas Indonesia, Jakarta, IndonesiaDepartment of Internal Medicine, Faculty of Medicine Universitas Indonesia - Cipto Mangunkusumo Hospital, Jakarta, IndonesiaBackground: scleroderma is an autoimmune disease characterized by organ fibrosis, resistant to standard treatment. It is suspected the addition of Physalis angulata Linn. (Ciplukan) extract as adjuvant therapy can improve the scleroderma skin fibrosis. The aim at this study is to evaluate the effect of ciplukan extract as adjuvant on scleroderma skin fibrosis in standard therapy, based on modified Rodnan skin scale (MRSS), inflammatory biomarkers, immunology and serum fibrosis. Methods: double-blind, randomized clinical trial was performed in scleroderma patients with stable disease at Cipto Mangunkusumo hospital and Hasan Sadikin hospital during November 2015−March 2017 who met the selection criteria and continued to receive standard therapy. The subjects were randomly allocated into two groups: the study group received the ciplukan extract 3 x 250 mg / day for 12 weeks and the placebo group. Examination of MRSS, ESR, P1NP, BAFF and sCD40L was performed every 4 weeks until the end of the study. Results: fifty-nine subjects completed the study. They consisted of 29 subjects of the treatment group and 30 of the placebo group, with an average age of 41 (SD 9) years, the proportion of women: male = 9 : 1. There was a significant improvement of skin fibrosis in the study group with a highly significant decrease in MRSS (35.9% VS 6.3%, p <0.001) and a relative decrease in P1NP levels (17.8% VS 0.7%, p = 0.002). No decrease in ESR, BAFF and sCD40L levels in both groups. There was a weak but significant positive correlation between MRSS with P1NP levels (r = 0.236, p = 0.036). Conclusion: Ciplukan extract with dose 3 x 250 mg for 12 weeks as adjuvant on scleroderma standard therapy alleviates skin fibrosis significantly based on MRSS and P1NP levels. https://actamedindones.org/index.php/ijim/article/view/1387Physalis angulata Linnmodified Rodnan’s skin score (MRSS)erythrocyte sedimentation rate (ESR)procollagen type-1 N terminal proteinase (P1NP)scleroderma |
| spellingShingle | Sumartini Dewi Harry Isbagio Erni Hernawati Purwaningsih Nyoman Kertia Rianto Setiabudy Siti Setiati A Double-blind, Randomized Controlled Trial of Ciplukan (Physalis angulata Linn) Extract on Skin Fibrosis, Inflammatory, Immunology, and Fibrosis Biomarkers in Scleroderma Patients Acta Medica Indonesiana Physalis angulata Linn modified Rodnan’s skin score (MRSS) erythrocyte sedimentation rate (ESR) procollagen type-1 N terminal proteinase (P1NP) scleroderma |
| title | A Double-blind, Randomized Controlled Trial of Ciplukan (Physalis angulata Linn) Extract on Skin Fibrosis, Inflammatory, Immunology, and Fibrosis Biomarkers in Scleroderma Patients |
| title_full | A Double-blind, Randomized Controlled Trial of Ciplukan (Physalis angulata Linn) Extract on Skin Fibrosis, Inflammatory, Immunology, and Fibrosis Biomarkers in Scleroderma Patients |
| title_fullStr | A Double-blind, Randomized Controlled Trial of Ciplukan (Physalis angulata Linn) Extract on Skin Fibrosis, Inflammatory, Immunology, and Fibrosis Biomarkers in Scleroderma Patients |
| title_full_unstemmed | A Double-blind, Randomized Controlled Trial of Ciplukan (Physalis angulata Linn) Extract on Skin Fibrosis, Inflammatory, Immunology, and Fibrosis Biomarkers in Scleroderma Patients |
| title_short | A Double-blind, Randomized Controlled Trial of Ciplukan (Physalis angulata Linn) Extract on Skin Fibrosis, Inflammatory, Immunology, and Fibrosis Biomarkers in Scleroderma Patients |
| title_sort | double blind randomized controlled trial of ciplukan physalis angulata linn extract on skin fibrosis inflammatory immunology and fibrosis biomarkers in scleroderma patients |
| topic | Physalis angulata Linn modified Rodnan’s skin score (MRSS) erythrocyte sedimentation rate (ESR) procollagen type-1 N terminal proteinase (P1NP) scleroderma |
| url | https://actamedindones.org/index.php/ijim/article/view/1387 |
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