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| Name | Class |
|---|---|
| Fakultas Kedokteran Universitas Indonesia | OTHER |
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This is a prospective, double-blind, placebo-controlled and randomized study aimed to obtain a description of the efficacy and safety of Predimenol in alleviating headache.
Predimenol is a bioactive fraction extracted from Phaleria macrocarpa pericarpium (Mahkota Dewa).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group | Experimental | 2 tablets of Predimenol (400 mg Predimenol) |
|
| Treatment + Placebo Group | Experimental | 1 tablet of Predimenol (200 mg Predimenol) + 1 tablet of placebo |
|
| Control Group | Placebo Comparator | 2 tablets of placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Predimenol tablet | Drug | 2 tablets of Predimenol (400 mg Predimenol) will be taken with 220 mL of water (one glass of water). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analogue Scale (VAS) | VAS (Visual Analogue Scale) for headache (0 - 100), with 0 indicates asymptomatic and 100 refers to the most serious or severe symptom. VAS will be measured at baseline and 10 min, 20 min, 30 min, 1 hour, 2 hour after drug administration. | Time 0, 10 min, 20 min, 30 min, 1 hour, 2 hour |
| Adverse events | Any kind of adverse events (AE) and serious adverse events (SAE) will be observed throughout the study conduct. | Time 0, 10 min, 20 min, 30 min, 1 hour, 2 hour |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nalfriadi Nalfriadi, MD,SpPD,PhD | Department Pharmacology & Therapeutics Faculty of Medicine Universitas Indonesia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Imeri Fkui | Jakarta Pusat | DKI Jakarta | 10430 | Indonesia | ||
| Klinik Satelit Makara UI Depok |
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| ID | Term |
|---|---|
| D006261 | Headache |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Predimenol tablet + Placebo tablet of Predimenol | Drug | 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 | Drug | 2 tablets of placebo tablet of Predimenol will be taken with 220 mL of water (one glass of water). |
|
| Depok |
| West Java |
| Indonesia |