HeadachePhase 2NCT06558006
Safety and Efficacy Predimenol for Headache
A Phase 2 study testing Predimenol tablet in people with Headache, run by Dexa Medica Group at 2 sites in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Headache
- What is being tested?
- Predimenol tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 2 sitesIndonesia
- Study dates
- 19 Jun 2024to 15 Oct 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Healthy men or women aged 18 to 60 years with acute moderate tomoderate-severe headache.
- Signing the informed consent.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Indonesia2 sites
Klinik Satelit Makara UI Depok
Depok, West Java
Imeri Fkui
Jakarta Pusat, DKI Jakarta, 10430
About this study
Official title: 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.
Read the 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.
- Conditions
- Headache
- Being tested
- Predimenol tablet, Predimenol tablet + Placebo tablet of Predimenol, Placebo tablet of Predimenol
- Keywords
- Predimenol, Headache
- Medical subject headings
- Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Predimenol tabletDrug
Also called HerbaPAIN
2 tablets of Predimenol (400 mg Predimenol) will be taken with 220 mL of water (one glass of water).
Predimenol tablet + Placebo tablet of PredimenolDrug
1 tablet of Predimenol (200 mg Predimenol) + 1 tablet of placebo will be taken with 220 mL of water (one glass of water).
Placebo tablet of PredimenolDrug
2 tablets of placebo tablet of Predimenol will be taken with 220 mL of water (one glass of water).
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | 2 tablets of Predimenol (400 mg Predimenol) Receives: Drug: Predimenol tablet |
| Treatment + Placebo Group | Experimental | 1 tablet of Predimenol (200 mg Predimenol) + 1 tablet of placebo Receives: Drug: Predimenol tablet + Placebo tablet of Predimenol |
| Control Group | Placebo comparator | 2 tablets of placebo Receives: Drug: Placebo tablet of Predimenol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Time 0, 10 min, 20 min, 30 min, 1 hour, 2 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2024
- Study start19 Jun 2024
- Primary completion15 Oct 2024
- Study completion15 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HeadacheStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dexa Medica Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Fakultas Kedokteran Universitas Indonesia
- Responsible party
- Sponsor
- Investigators
- Nalfriadi Nalfriadi, MD,SpPD,PhD, Principal investigator, Department Pharmacology & Therapeutics Faculty of Medicine Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06558006
- Sponsor's protocol ID
- CRSU.P.Dexa/06/20/13.04
- Status last verified
- Feb 2025
- First submitted
- 14 Aug 2024
- Last updated
- 7 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Predimenol for Headache: A Preliminary Study
- ClinicalTrials.gov ID
- NCT06558006
- Acronym / sponsor ID
- CRSU.P.Dexa/06/20/13.04
- Conditions
- Headache
- Keywords
- Predimenol, Headache
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Dexa Medica GroupIndustry (pharma, biotech, devices)
- Collaborators
- Fakultas Kedokteran Universitas Indonesia
- Study start
- 19 Jun 2024 (actual)
- Primary completion
- 15 Oct 2024 (actual)
- Study completion
- 15 Oct 2024 (actual)
- First posted
- 16 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
The investigational drug: tablet @200 mg of Predimenol. Dose administration: one singe dose (two tablets) of Predimenol or Placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Drug: Predimenol tablet2 tablets of Predimenol (400 mg Predimenol) |
| Treatment + Placebo Group | Experimental | Drug: Predimenol tablet + Placebo tablet of Predimenol1 tablet of Predimenol (200 mg Predimenol) + 1 tablet of placebo |
| Control Group | Placebo comparator | Drug: Placebo tablet of Predimenol2 tablets of placebo |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy men or women aged 18 to 60 years with acute moderate tomoderate-severe headache.
- Signing the informed consent.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Predimenol tabletAlso: HerbaPAIN2 tablets of Predimenol (400 mg Predimenol) will be taken with 220 mL of water (one glass of water). | Drug | Treatment Group |
| Predimenol tablet + Placebo tablet of Predimenol1 tablet of Predimenol (200 mg Predimenol) + 1 tablet of placebo will be taken with 220 mL of water (one glass of water). | Drug | Treatment + Placebo Group |
| Placebo tablet of Predimenol2 tablets of placebo tablet of Predimenol will be taken with 220 mL of water (one glass of water). | Drug | Control Group |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nalfriadi Nalfriadi, MD,SpPD,PhD principal investigator
Department Pharmacology & Therapeutics Faculty of Medicine Universitas Indonesia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Predimenol tablet in people with Headache, run by Dexa Medica Group at 2 sites in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale (VAS) (time frame: Time 0, 10 min, 20 min, 30 min, 1 hour, 2 hour). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2025; AzTrials last refreshed its copy on 3 Nov 2026.