Headache
Conditions
Keywords
Predimenol, Headache
Brief summary
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.
Detailed description
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.
Interventions
DRUGPredimenol 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).
DRUGPredimenol tablet
2 tablets of Predimenol (400 mg Predimenol) will be taken with 220 mL of water (one glass of water).
DRUGPlacebo tablet of Predimenol
2 tablets of placebo tablet of Predimenol will be taken with 220 mL of water (one glass of water).
Sponsors
Fakultas Kedokteran Universitas Indonesia
Dexa Medica Group
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
1. Healthy men or women aged 18 to 60 years with acute moderate tomoderate-severe headache. 2. Signing the informed consent.
Exclusion criteria
1. Body temperature of \>37.3˚C and/or refuse to follow health protocol for COVID-19. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analogue Scale (VAS) | Time 0, 10 min, 20 min, 30 min, 1 hour, 2 hour | 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. |
| Adverse events | Time 0, 10 min, 20 min, 30 min, 1 hour, 2 hour | Any kind of adverse events (AE) and serious adverse events (SAE) will be observed throughout the study conduct. |
Countries
Indonesia
Outcome results
None listed