Safety and Efficacy Predimenol for Headache

Safety and Efficacy of Predimenol for Headache: A Preliminary Study

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.

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.