Back to resultsThe Effect of Ethanol Extract Physalis Angulata Linn. in Scleroderma Patients With Standard Therapy
Primary Purpose
Scleroderma
Status
Completed
Phase
Not Applicable
Locations
Indonesia
Study Type
Interventional
Intervention
Physalis angulata ethanol extract
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Scleroderma focused on measuring Erythrocyte sedimentation rate, Modified Rodnan Skin Score, B-cell Activating Factor, soluble-CD40Ligand, Procollagen Type-1 N-terminal Propeptide, Scleroderma
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Hasan Sadikin Hospital
- Ciptomangunkusumo Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Physalis angulata ethanol extract
Placebo
Arm Description
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.
Patients received standard therapy and placebo (amylum powder) for comparator at dosage 3 x 250 mg/day, orally, for 3 months.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Level of P1NP serum
Improvement is defined if there is a significant reduced of P1NP serum level
Value of ESR
Improvement is defined if there is a significant reduced of ESR value
Level of BAFF serum
Improvement is defined if there is a significant reduced of BAFF serum level
Level of sCD40L serum
Improvement is defined if there is a significant reduced of sCD40L serum level.
Full Information
NCT ID
NCT03141125
First Posted
June 20, 2016
Last Updated
August 27, 2017
Sponsor
Indonesia University
Collaborators
Netherlands: Ministry of Health, Welfare and Sports
1. Study Identification
Unique Protocol Identification Number
NCT03141125
Brief Title
The Effect of Ethanol Extract Physalis Angulata Linn. in Scleroderma Patients With Standard Therapy
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 Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
January 2016 (Actual)
Primary Completion Date
August 2017 (Actual)
Study Completion Date
August 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indonesia University
Collaborators
Netherlands: Ministry of Health, Welfare and Sports
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
Detailed Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scleroderma
Keywords
Erythrocyte sedimentation rate, Modified Rodnan Skin Score, B-cell Activating Factor, soluble-CD40Ligand, Procollagen Type-1 N-terminal Propeptide, Scleroderma
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Physalis angulata Linn. ethanol extract 3 x 250 mg
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Double blind randomized placebo controlled trial
Allocation
Randomized
Enrollment
62 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Physalis angulata ethanol extract
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Patients received standard therapy and placebo (amylum powder) for comparator at dosage 3 x 250 mg/day, orally, for 3 months.
Intervention Type
Other
Intervention Name(s)
Physalis angulata ethanol extract
Other Intervention Name(s)
Herba Ciplukan, Ethanol extract of Physalis angulata Linn, Ethanol extract of Physalis angulata
Intervention Description
Ethanol extract of physalis angulate Linn with dosage of 3x250 mg/day given orally for 3 months
Intervention Type
Other
Intervention Name(s)
Placebo
Other Intervention Name(s)
Amylum
Intervention Description
No active component at the same dosage of 3x250 mg/day given orally for 3 months
Primary Outcome Measure Information:
Title
Degree of skin fibrosis based on modified Rodnan Skin Score (mRSS)
Description
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.
Time Frame
3 months of intervention
Secondary Outcome Measure Information:
Title
Level of P1NP serum
Description
Improvement is defined if there is a significant reduced of P1NP serum level
Time Frame
3 months of intervention
Title
Value of ESR
Description
Improvement is defined if there is a significant reduced of ESR value
Time Frame
3 months of intervention
Title
Level of BAFF serum
Description
Improvement is defined if there is a significant reduced of BAFF serum level
Time Frame
3 months of intervention
Title
Level of sCD40L serum
Description
Improvement is defined if there is a significant reduced of sCD40L serum level.
Time Frame
3 months of intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Harry Isbagio, MD, Prof.
Organizational Affiliation
Department of Internal Medicine
Official's Role
Study Chair
Facility Information:
Facility Name
Hasan Sadikin Hospital
City
Bandung
State/Province
West Java
ZIP/Postal Code
40161
Country
Indonesia
Facility Name
Ciptomangunkusumo Hospital
City
Jakarta
ZIP/Postal Code
10430
Country
Indonesia
12. IPD Sharing Statement
Plan to Share IPD
No
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The Effect of Ethanol Extract Physalis Angulata Linn. in Scleroderma Patients With Standard Therapy
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