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Safety and Efficacy Predimenol for Headache

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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

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

Trial contacts and locations

2

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Central trial contact

Taruna Dibya, MD; Liana W Susanto, Pharm,MBiomed

Data sourced from clinicaltrials.gov

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