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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
Sponsor:
Collaborator:
Netherlands: Ministry of Health, Welfare and Sports
Information provided by (Responsible Party):
Sumartini Dewi, Indonesia University

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

Condition or disease Intervention/treatment Phase
Scleroderma Other: Physalis angulata ethanol extract Other: Placebo Not Applicable

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


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: Randomized
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
Primary Purpose: Treatment
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


Arm Intervention/treatment
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
Other Names:
  • Herba Ciplukan
  • Ethanol extract of Physalis angulata Linn
  • Ethanol extract of Physalis angulata

Placebo Comparator: Placebo
Patients received standard therapy and placebo (amylum powder) for comparator at dosage 3 x 250 mg/day, orally, for 3 months.
Other: Placebo
No active component at the same dosage of 3x250 mg/day given orally for 3 months
Other Name: Amylum




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Level of P1NP serum [ Time Frame: 3 months of intervention ]
    Improvement is defined if there is a significant reduced of P1NP serum level

  2. Value of ESR [ Time Frame: 3 months of intervention ]
    Improvement is defined if there is a significant reduced of ESR value

  3. Level of BAFF serum [ Time Frame: 3 months of intervention ]
    Improvement is defined if there is a significant reduced of BAFF serum level

  4. Level of sCD40L serum [ Time Frame: 3 months of intervention ]
    Improvement is defined if there is a significant reduced of sCD40L serum level.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients who meet the criteria of the type of limited scleroderma diagnosis / limited or diffuse type.
  2. 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.
  3. The research subjects aged 15 to 60 years.
  4. Subjects with modified Rodnan Skin score ≥ 5.
  5. Disease duration ≥ 1 year

Exclusion Criteria:

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

Information from the National Library of Medicine

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


Locations
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Indonesia
Hasan Sadikin Hospital
Bandung, West Java, Indonesia, 40161
Ciptomangunkusumo Hospital
Jakarta, Indonesia, 10430
Sponsors and Collaborators
Indonesia University
Netherlands: Ministry of Health, Welfare and Sports
Investigators
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Study Chair: Harry Isbagio, MD, Prof. Department of Internal Medicine

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Responsible Party: Sumartini Dewi, MD, Master of Health, Indonesia University
ClinicalTrials.gov Identifier: NCT03141125     History of Changes
Other Study ID Numbers: UI-PAL/CCD-SSc.2016
First Posted: May 4, 2017    Key Record Dates
Last Update Posted: August 29, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Sumartini Dewi, Indonesia University:
Erythrocyte sedimentation rate
Modified Rodnan Skin Score
B-cell Activating Factor
soluble-CD40Ligand
Procollagen Type-1 N-terminal Propeptide
Scleroderma
Additional relevant MeSH terms:
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Scleroderma, Systemic
Scleroderma, Diffuse
Scleroderma, Localized
Connective Tissue Diseases
Skin Diseases
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs