Safety and Efficacy Predimenol for Headache

Phase 2

Completed

• Conditions: Headache
• Interventions: Drug: Predimenol tablet; Drug: Predimenol tablet + Placebo tablet of Predimenol; Drug: Placebo tablet of Predimenol

• Registration Number: NCT06558006
• Lead Sponsor: Dexa Medica Group

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.

Study Timeline

• Study Start: 2024-06-19
• Study First Submitted: 2024-08-14
• Study First Submitted QC: 2024-08-14
• Study First Posted: 2024-08-16
• Primary Completion: 2024-10-15
• Study Completion: 2024-10-15
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-05
• Last Update Posted: 2025-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment Group	Predimenol tablet	2 tablets of Predimenol (400 mg Predimenol)
Treatment + Placebo Group	Predimenol tablet + Placebo tablet of Predimenol	1 tablet of Predimenol (200 mg Predimenol) + 1 tablet of placebo
Control Group	Placebo tablet of Predimenol	2 tablets of placebo

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (2)

Imeri Fkui; 🇮🇩 Jakarta Pusat, DKI Jakarta, Indonesia

Klinik Satelit Makara UI Depok; 🇮🇩 Depok, Jawa Barat, Indonesia