NCT03141125

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2016

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 20, 2016

Completed
11 months until next milestone

First Posted

Study publicly available on registry

May 4, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

August 29, 2017

Status Verified

August 1, 2017

Enrollment Period

1.6 years

First QC Date

June 20, 2016

Last Update Submit

August 27, 2017

Conditions

Scleroderma

Keywords

Erythrocyte sedimentation rateModified Rodnan Skin ScoreB-cell Activating Factorsoluble-CD40LigandProcollagen Type-1 N-terminal PropeptideScleroderma

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Level of P1NP serum

    3 months of intervention

  • Value of ESR

    3 months of intervention

  • Level of BAFF serum

    3 months of intervention

  • Level of sCD40L serum

    3 months of intervention

Study Arms (2)

Physalis angulata ethanol extract

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

Patients received standard therapy and placebo (amylum powder) for comparator at dosage 3 x 250 mg/day, orally, for 3 months.

Other: Placebo

Interventions

Physalis angulata ethanol extractOTHER

Ethanol extract of physalis angulate Linn with dosage of 3x250 mg/day given orally for 3 months

Also known as: Herba Ciplukan, Ethanol extract of Physalis angulata Linn, Ethanol extract of Physalis angulata
Physalis angulata ethanol extract
PlaceboOTHER

No active component at the same dosage of 3x250 mg/day given orally for 3 months

Also known as: Amylum
Placebo

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients who meet the criteria of the type of limited scleroderma diagnosis / limited or diffuse type.
  • 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.
  • The research subjects aged 15 to 60 years.
  • Subjects with modified Rodnan Skin score ≥ 5.
  • Disease duration ≥ 1 year

You may not qualify if:

  • Impaired liver function with cirrhosis
  • Chronic Renal dysfunction (chronic kidney disease stages 4-5). Or creatinine levels\> 2 mg / dL in the last 1 month prior to randomization.
  • Other autoimmune disease/overlap syndrome.
  • Received a steroid/prednisone \>10 mg/day in the last 1 month.
  • Patients who are pregnant or breastfeeding.
  • Patients with active tuberculosis and or are being treated with anti-tuberculosis medicines.
  • Severe heart disease. (Heart Disease with impaired function according to the New York Heart Association Class III or IV)
  • History of allergies to herbal Ciplukan / Physalis angulate Linn. or a history of hypersensitivity to certain drugs.
  • Hypotension (BP \<90/60 mmHg)
  • Hypoglycemia (Glucose level \<70 mg / dL)
  • Do not want to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hasan Sadikin Hospital

Bandung, West Java, 40161, Indonesia

Location

Ciptomangunkusumo Hospital

Jakarta, 10430, Indonesia

Location

MeSH Terms

Conditions

Scleroderma, Diffuse

Interventions

Starch

Condition Hierarchy (Ancestors)

Scleroderma, SystemicConnective Tissue DiseasesSkin and Connective Tissue DiseasesSkin Diseases

Intervention Hierarchy (Ancestors)

GlucansBiopolymersPolymersMacromolecular SubstancesDietary CarbohydratesCarbohydratesPolysaccharides

Study Officials

  • Harry Isbagio, MD, Prof.

    Department of Internal Medicine

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Double blind randomized placebo controlled trial
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Physalis angulata Linn. ethanol extract 3 x 250 mg
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Master of Health

Study Record Dates

First Submitted

June 20, 2016

First Posted

May 4, 2017

Study Start

January 1, 2016

Primary Completion

August 1, 2017

Study Completion

August 1, 2017

Last Updated

August 29, 2017

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will not share

Locations

ID(2)