Safety and Efficacy Predimenol for Headache

NCT06558006 | Completed Phase 2

• 1 other identifier: CRSU.P.Dexa/06/20/13.04
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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.

Conditions

Headache

Keywords

Predimenol; Headache

Outcome Measures

Primary Outcomes (2)

• Visual Analogue Scale (VAS)

  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

  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

Study Arms (3)

Treatment Group

EXPERIMENTAL

2 tablets of Predimenol (400 mg Predimenol)

Drug: Predimenol tablet

Treatment + Placebo Group

EXPERIMENTAL

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

Drug: Predimenol tablet + Placebo tablet of Predimenol

Control Group

PLACEBO COMPARATOR

2 tablets of placebo

Drug: Placebo tablet of Predimenol

Interventions

Predimenol tablet DRUG

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

Also known as: HerbaPAIN

Treatment Group

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).

Treatment + Placebo Group

Placebo tablet of Predimenol DRUG

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

Control Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dexa Medica Group: lead
• Fakultas Kedokteran Universitas Indonesia: collaborator

Study Sites (2)

Imeri Fkui

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

Location

Klinik Satelit Makara UI Depok

Depok, West Java, Indonesia

Location

MeSH Terms

Conditions

Headache

Condition Hierarchy (Ancestors)

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

Study Officials

• Nalfriadi Nalfriadi, MD,SpPD,PhD

  Department Pharmacology & Therapeutics Faculty of Medicine Universitas Indonesia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2024
• First Posted: August 16, 2024
• Study Start: June 19, 2024
• Primary Completion: October 15, 2024
• Study Completion: October 15, 2024
• Last Updated: February 7, 2025

Record last verified: 2025-02

Locations

ID (2)