NCT06558006

Safety and Efficacy Predimenol for Headache

Safety and Efficacy of Predimenol for Headache: A Preliminary Study

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Dexa Medica Group · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Headache

Interventions

Type	Name	Description
DRUG	Predimenol tablet	2 tablets of Predimenol (400 mg Predimenol) will be taken with 220 mL of water (one glass of water).
DRUG	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).
DRUG	Placebo tablet of Predimenol	2 tablets of placebo tablet of Predimenol will be taken with 220 mL of water (one glass of water).

Timeline

• Start date: 2024-06-19
• Primary completion: 2024-10-15
• Completion: 2024-10-15
• First posted: 2024-08-16
• Last updated: 2025-02-07

Locations

2 sites across 1 country: Indonesia