SclerodermaNCT03141125
The Effect of Ethanol Extract Physalis Angulata Linn. in Scleroderma Patients With Standard Therapy
A study testing Physalis angulata ethanol extract in people with Scleroderma, run by Universitas Indonesia at 2 sites in Indonesia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Scleroderma
- What is being tested?
- Physalis angulata ethanol extract
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- 2 sitesIndonesia
- Study dates
- Jan 2016to Aug 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
2 sites in 1 country.
Indonesia2 sites
Hasan Sadikin Hospital
Bandung, West Java, 40161
Ciptomangunkusumo Hospital
Jakarta, 10430
About this study
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
Read the 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
- Conditions
- Scleroderma
- Being tested
- Physalis angulata ethanol extract, Placebo
- Keywords
- Erythrocyte sedimentation rate, Modified Rodnan Skin Score, B-cell Activating Factor, soluble-CD40Ligand, Procollagen Type-1 N-terminal Propeptide, Scleroderma
- Medical subject headings
- Scleroderma, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physalis angulata ethanol extractOther
Also called Herba Ciplukan, Ethanol extract of Physalis angulata Linn, Ethanol extract of Physalis angulata
Ethanol extract of physalis angulate Linn with dosage of 3x250 mg/day given orally for 3 months
PlaceboOther
Also called Amylum
No active component at the same dosage of 3x250 mg/day given orally for 3 months
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months of intervention
Secondary outcomes (4)
Level of P1NP serum
Improvement is defined if there is a significant reduced of P1NP serum level
Measured: 3 months of intervention
Value of ESR
Improvement is defined if there is a significant reduced of ESR value
Measured: 3 months of intervention
Level of BAFF serum
Improvement is defined if there is a significant reduced of BAFF serum level
Measured: 3 months of intervention
Level of sCD40L serum
Improvement is defined if there is a significant reduced of sCD40L serum level.
Measured: 3 months of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2017
- Study startJan 2016
- Primary completionAug 2017
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SclerodermaStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Physalis angulata Linn. ethanol extract 3 x 250 mg
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Collaborators
- Netherlands: Ministry of Health, Welfare and Sports
- Responsible party
- Principal investigator, Sumartini Dewi, Universitas Indonesia
- Investigators
- Harry Isbagio, MD, Prof., Study chair, Department of Internal Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03141125
- Sponsor's protocol ID
- UI-PAL/CCD-SSc.2016
- Status last verified
- Aug 2017
- First submitted
- 20 Jun 2016
- Last updated
- 29 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03141125
- Acronym / sponsor ID
- UI-PAL/CCD-SSc.2016
- Conditions
- Scleroderma
- Keywords
- Erythrocyte sedimentation rate, Modified Rodnan Skin Score, B-cell Activating Factor, soluble-CD40Ligand, Procollagen Type-1 N-terminal Propeptide, Scleroderma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Collaborators
- Netherlands: Ministry of Health, Welfare and Sports
- Study start
- Jan 2016 (actual)
- Primary completion
- Aug 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 4 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Physalis angulata Linn. ethanol extract 3 x 250 mg
| Arm | Type | Receives |
|---|---|---|
| Physalis angulata ethanol extract | Experimental | Other: Physalis angulata ethanol extractPhysalis 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. |
| Placebo | Placebo comparator | Other: PlaceboPatients received standard therapy and placebo (amylum powder) for comparator at dosage 3 x 250 mg/day, orally, for 3 months. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physalis angulata ethanol extractAlso: Herba Ciplukan, Ethanol extract of Physalis angulata Linn, Ethanol extract of Physalis angulataEthanol extract of physalis angulate Linn with dosage of 3x250 mg/day given orally for 3 months | Other | Physalis angulata ethanol extract |
| PlaceboAlso: AmylumNo active component at the same dosage of 3x250 mg/day given orally for 3 months | Other | Placebo |
Primary outcome
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.
4 secondary outcomes
Level of P1NP serum
Time frame: 3 months of intervention
Value of ESR
Time frame: 3 months of intervention
Level of BAFF serum
Time frame: 3 months of intervention
Level of sCD40L serum
Time frame: 3 months of intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Harry Isbagio, MD, Prof. study chair
Department of Internal Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physalis angulata ethanol extract in people with Scleroderma, run by Universitas Indonesia at 2 sites in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Degree of skin fibrosis based on modified Rodnan Skin Score (mRSS) (time frame: 3 months of intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2017.