Safety and Efficacy Predimenol for Headache

February 5, 2025 updated by: Dexa Medica Group

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
    • DKI Jakarta
      • Jakarta Pusat, DKI Jakarta, Indonesia, 10430
        • Imeri Fkui
    • Jawa Barat
      • Depok, Jawa Barat, Indonesia
        • Klinik Satelit Makara UI Depok

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment Group
2 tablets of Predimenol (400 mg Predimenol)
Drug: Predimenol tablet
2 tablets of Predimenol (400 mg Predimenol) will be taken with 220 mL of water (one glass of water).
Other Names:
  • HerbaPAIN
Experimental: Treatment + Placebo Group
1 tablet of Predimenol (200 mg Predimenol) + 1 tablet of placebo
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).
Placebo Comparator: Control Group
2 tablets of placebo
Drug: Placebo tablet of Predimenol
2 tablets of placebo tablet of Predimenol will be taken with 220 mL of water (one glass of water).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time 0, 10 min, 20 min, 30 min, 1 hour, 2 hour
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.
Time 0, 10 min, 20 min, 30 min, 1 hour, 2 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dexa Medica Group

Collaborators

Fakultas Kedokteran Universitas Indonesia

Investigators

  • Principal Investigator: Nalfriadi Nalfriadi, MD,SpPD,PhD, Department Pharmacology & Therapeutics Faculty of Medicine Universitas Indonesia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 19, 2024

Primary Completion (Actual)

October 15, 2024

Study Completion (Actual)

October 15, 2024

Study Registration Dates

First Submitted

August 14, 2024

First Submitted That Met QC Criteria

August 14, 2024

First Posted (Actual)

August 16, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 5, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRSU.P.Dexa/06/20/13.04

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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