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
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
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
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02798055 -
Bosentan Treatment of Digital Ulcers Related to Systemic Sclerosis
|
||
| Completed |
NCT01959815 -
Novel Screening Strategies for Scleroderma PAH
|
||
| Completed |
NCT03274076 -
Evaluation of Tofacitinib in Early Diffuse Cutaneous Systemic Sclerosis (dcSSc)
|
Phase 1/Phase 2 | |
| Completed |
NCT02915835 -
Riociguat in Scleroderma Associated Digital Ulcers
|
Phase 2 | |
| Active, not recruiting |
NCT01895244 -
Autologous Stem Cell Transplantation for Progressive Systemic Sclerosis
|
Phase 2 | |
| Completed |
NCT00930683 -
A Study to Evaluate Safety and Tolerability of Multiple Doses of MEDI-546 in Adult Subjects With Scleroderma
|
Phase 1 | |
| Completed |
NCT00883129 -
Comparison of Therapeutic Regimens for Scleroderma Interstitial Lung Disease (The Scleroderma Lung Study II)
|
Phase 2 | |
| Completed |
NCT00074568 -
Scleroderma Registry
|
||
| Recruiting |
NCT04797286 -
Sildenafil for Early Pulmonary Vascular Disease in Scleroderma
|
Phase 2 | |
| Completed |
NCT03222492 -
Brentuximab Vedotin for Systemic Sclerosis
|
Phase 1/Phase 2 | |
| Completed |
NCT03207997 -
MRI Quantification of Pulmonary Fibrosis in Scleroderma Patients
|
N/A | |
| Recruiting |
NCT04464434 -
Upfront Autologous HSCT Versus Immunosuppression in Early Diffuse Cutaneous Systemic Sclerosis
|
Phase 4 | |
| Recruiting |
NCT04246528 -
SPIN Self-Management Feasibility Trial With Progression to Full-scale Trial (SPIN-SELF)
|
N/A | |
| Completed |
NCT05080738 -
Upper Extremity Home Exercises in Patients With Scleroderma
|
N/A | |
| Recruiting |
NCT03726398 -
CompRehensive Phenotypic Characterization of Patients With Scleroderma-Associated ILD and PH
|
Phase 2/Phase 3 | |
| Recruiting |
NCT05085444 -
A Study of CD19/BCMA Chimeric Antigen Receptor T Cells Therapy for Patients With Refractory Scleroderma
|
Early Phase 1 | |
| Completed |
NCT02062125 -
Calcinosis in a Single-Center Scleroderma Population
|
||
| Completed |
NCT04588714 -
Feasibility and Preliminary Effects of the Resilience-based, Energy Management to Enhance Wellbeing in Systemic Sclerosis (RENEW) Intervention
|
N/A | |
| Recruiting |
NCT05635266 -
Tissue Repository Providing Annotated Biospecimens for Approved Investigator-directed Biomedical Research Initiatives
|
||
| Completed |
NCT02835196 -
Optical Elastography of Systemic Sclerosis Skin
|