Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
60 participants
INTERVENTIONAL
2024-06-19
2024-10-15
Brief Summary
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Detailed Description
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There will be 20 subjects per group (a total of 60 subjects) planned to be enrolled in the study.
The investigational drug: tablet @200 mg of Predimenol. Dose administration: one singe dose (two tablets) of Predimenol or Placebo.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Treatment Group
2 tablets of Predimenol (400 mg Predimenol)
Predimenol tablet
2 tablets of Predimenol (400 mg Predimenol) will be taken with 220 mL of water (one glass of water).
Treatment + Placebo Group
1 tablet of Predimenol (200 mg Predimenol) + 1 tablet of placebo
Predimenol tablet + Placebo tablet of Predimenol
1 tablet of Predimenol (200 mg Predimenol) + 1 tablet of placebo will be taken with 220 mL of water (one glass of water).
Control Group
2 tablets of placebo
Placebo tablet of Predimenol
2 tablets of placebo tablet of Predimenol will be taken with 220 mL of water (one glass of water).
Interventions
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Predimenol tablet
2 tablets of Predimenol (400 mg Predimenol) will be taken with 220 mL of water (one glass of water).
Predimenol tablet + Placebo tablet of Predimenol
1 tablet of Predimenol (200 mg Predimenol) + 1 tablet of placebo will be taken with 220 mL of water (one glass of water).
Placebo tablet of Predimenol
2 tablets of placebo tablet of Predimenol will be taken with 220 mL of water (one glass of water).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Signing the informed consent.
Exclusion Criteria
2. Known hypersensitivity to herbal drugs.
3. Pregnant or lactating women.
4. Have received any analgesic or anti-inflammatory drugs within the past 12 hours.
5. Presence of vomiting or diarrhea within the past 24 hours or still ongoing at the start of study.
6. Severe illness, e.g. severe hypertension, or any known organic diseases that may cause headache.
18 Years
60 Years
ALL
No
Sponsors
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Fakultas Kedokteran Universitas Indonesia
OTHER
Dexa Medica Group
INDUSTRY
Responsible Party
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Principal Investigators
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Nalfriadi Nalfriadi, MD,SpPD,PhD
Role: PRINCIPAL_INVESTIGATOR
Department Pharmacology & Therapeutics Faculty of Medicine Universitas Indonesia
Locations
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Imeri Fkui
Jakarta Pusat, DKI Jakarta, Indonesia
Klinik Satelit Makara UI Depok
Depok, West Java, Indonesia
Countries
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Other Identifiers
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CRSU.P.Dexa/06/20/13.04
Identifier Type: -
Identifier Source: org_study_id
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