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Completed

NCT Number: NCT06558006

Safety and Efficacy Predimenol for Headache

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.

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Key information

Conditions

Headache Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Imeri Fkui, Jakarta Pusat, DKI Jakarta, Indonesia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy men or women aged 18 to 60 years with acute moderate tomoderate-severe headache.
  • Signing the informed consent.

Exclusion criteria

  • Body temperature of >37.3˚C and/or refuse to follow health protocol for COVID-19.
  • Known hypersensitivity to herbal drugs.
  • Pregnant or lactating women.
  • Have received any analgesic or anti-inflammatory drugs within the past 12 hours.
  • Presence of vomiting or diarrhea within the past 24 hours or still ongoing at the start of study.
  • Severe illness, e.g. severe hypertension, or any known organic diseases that may cause headache.

Treatment and study plan

Predimenol tablet

Drug

2 tablets of Predimenol (400 mg Predimenol) will be taken with 220 mL of water (one glass of water).

Other names: HerbaPAIN

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).

Primary outcomes

  1. Visual Analogue Scale (VAS)

    Time frame: 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.

  2. Adverse events

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Dexa Medica Group

Industry

Collaborators

  • Fakultas Kedokteran Universitas Indonesia

Registry information

Official study title

Safety and Efficacy of Predimenol for Headache: A Preliminary Study

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Aug 16, 2024
Registry last updated
Feb 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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