Safety and Efficacy Predimenol for Headache

Dexa Medica

Status and phase: Enrolling; Phase 2

Conditions: Headache

Treatments: Drug: Predimenol tablet + Placebo tablet of Predimenol; Drug: Placebo tablet of Predimenol; Drug: Predimenol tablet

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06558006

CRSU.P.Dexa/06/20/13.04

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 3 patient groups, including a placebo group

Treatment Group

Experimental group

Description:

2 tablets of Predimenol (400 mg Predimenol)

Treatment:

Drug: Predimenol tablet

Treatment + Placebo Group

Experimental group

Description:

1 tablet of Predimenol (200 mg Predimenol) + 1 tablet of placebo

Treatment:

Drug: Predimenol tablet + Placebo tablet of Predimenol

Control Group

Placebo Comparator group

Description:

2 tablets of placebo

Treatment:

Drug: Placebo tablet of Predimenol