Status:
COMPLETED
Safety and Efficacy Predimenol for Headache
Lead Sponsor:
Dexa Medica Group
Collaborating Sponsors:
Fakultas Kedokteran Universitas Indonesia
Conditions:
Headache
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
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.
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. Th...
Eligibility Criteria
Inclusion
- Healthy men or women aged 18 to 60 years with acute moderate tomoderate-severe headache.
- Signing the informed consent.
Exclusion
- 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.
Key Trial Info
Start Date :
June 19 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 15 2024
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06558006
Start Date
June 19 2024
End Date
October 15 2024
Last Update
February 7 2025
Active Locations (2)
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1
Imeri Fkui
Jakarta Pusat, DKI Jakarta, Indonesia, 10430
2
Klinik Satelit Makara UI Depok
Depok, West Java, Indonesia