MigraineNCT07067853
Effectivity and Safety of GB20 Acupoint Pharmacopuncture With Lidocaine 2% on Migraine Patients
A study testing Lidocaine 2 % Pharmacopuncture and propranolol 20mg in people with Migraine, run by Universitas Indonesia at 1 site in Indonesia.
Trial summary
The goal of this clinical trial is to learn if 2% Lidocaine pharmacopuncture at the GB20 acupoint can effectively and safely treat migraine in adult patients. The main questions it aims to answer are: Does 2% Lidocaine pharmacopuncture at GB20 reduce the frequency of migraine attacks more than 40mg propranolol? Does… Read more about this study
- Who is it for?
- Ages 18 to 59 years
- Conditions the study is for
- Migraine
- What is being tested?
- Lidocaine 2 % Pharmacopuncture and propranolol 20mg
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Sep 2025to 15 Dec 2025
- Phase
- Interventional
- 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 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosed with migraine
- Minimum of 3 days of migraine attacks in 1 month
- Willing to participate until the study concludes
Who cannot join
- Headache with other known cause (e.g. head trauma, cancer, hemorrhagic stroke)
- Inaccessible GB20 acupuncture point (scar tissue, infection, open wound, etc)
- History of heart disease and/or asthma
- History of Hypersensitivity with propranolol and/or lidocaine
- History of acupuncture treatment 3 month prior to study
- Routine consumption of anticoagulation medications, steroids or pain killers
- Pregnant and breastfeeding women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectivity and Safety of GB20 Acupoint Pharmacopuncture With Lidocaine 2% on Migraine Patients : Study on Head Pain Characteristic and MIDAS-Ina Score
The goal of this clinical trial is to learn if 2% Lidocaine pharmacopuncture at the GB20 acupoint can effectively and safely treat migraine in adult patients. The main questions it aims to answer are:
- Does 2% Lidocaine pharmacopuncture at GB20 reduce the frequency of migraine attacks more than 40mg propranolol?
- Does 2% Lidocaine pharmacopuncture at GB20 reduce the duration of migraine attacks more than 40mg propranolol?
- Does 2% Lidocaine pharmacopuncture at GB20 reduce the intensity of migraine pain more than 40mg propranolol?
- Does 2% Lidocaine pharmacopuncture at GB20 improve MIDAS-Ina scores more than 40mg propranolol?
- Is 2% Lidocaine pharmacopuncture at GB20 more effective in improving bothersome migraine symptoms compared to 40mg propranolol?
- What is the incidence of side effects of 2% Lidocaine pharmacopuncture at GB20 in migraine patients?
Read more
Researchers will compare a pharmacopuncture group to a conventional medication group (propranolol) to see if pharmacopuncture works as an effective and safe alternative treatment for migraine patients.
Participants will:
- In the pharmacopuncture group, receive weekly injections of 0.5cc of 2% Lidocaine at the GB20 acupoint (bilaterally) for four weeks. These injections will be guided by ultrasonography.
- In the medication group, receive 20mg propranolol tablets twice daily for 28 days.
- Be provided with 500mg Paracetamol tablets as abortive therapy for acute migraine attacks.
- Use the 'Guardian Headache Diary' application to record migraine attack data (frequency, duration, intensity) for two months.
- Complete the MIDAS-Ina questionnaire at the beginning of the study, at the end of week 4, and at the end of week 8.
Side effects will be monitored and recorded throughout the study.
- Conditions
- Migraine
- Being tested
- Lidocaine 2 % Pharmacopuncture, propranolol 20mg
- Keywords
- Migraine, Acupuncture
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine 2 % PharmacopunctureDevice
Injection of 0.5mL Lidocaine 2% solution into GB20 acupuncture point, both sides every week for 4 week
propranolol 20mgDrug
Propranolol 20mg, twice daily for 28 day / 4 week
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Injection of 0.5mL Lidocaine 2% solution into GB20 acupuncture point, both sides every week for 4 week Receives: Device: Lidocaine 2 % Pharmacopuncture |
| Control Group | Active comparator | Propranolol 20mg, twice daily for 28 day / 4 week Receives: Drug: propranolol 20mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of migraine attacks
Frequency of migraine attacks in 1 month
Measured: Before therapy, week 4, week 8
Duration of migraine attacks
Duration of migraine attacks, counted in hour
Measured: Before therapy, week 4, week 8
Intensity of migraine attacks
intensity of migraine attacks, measured with numeric rating scale from 1 to 10
Measured: Before therapy, week 4, week 8
Migraine Disability Assessment Test - Indonesian Language (MIDAS-Ina) Score
Disability caused by migraine will be assessed with Migraine Disability Assessment Test - Indonesian Language (MIDAS-Ina), a 5-question questionnaire with a minimum score of 0 and maximum score of 450. Higher score means worse outcome.
Measured: Before therapy, week 4, week 8
Bothersome Symptom Improvement
Improvement of bothersome symptoms, measured as improved or not improved
Measured: week 4, week 8
Adverse Event Related to Intervention
adverse event happening after intervention is given, including pain, infection, skin rash/irritation will be recorded and monitored
Measured: immediately post-intervention until 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2025
- Study start1 Sep 2025
- Primary completion1 Dec 2025
- Study completion15 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- The intervention group will receive pharmacopuncture, while the control group will receive propranolol tablets
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeffry Alamsjah, Universitas Indonesia
- Investigators
- Komite Etik Penelitian Kesehatan FKUI-RSCM, Principal investigator, Health Research Ethics Commitee - Faculty of Medicine Universitas Indonesia and Dr. Cipto Mangunkusumo National Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07067853
- Sponsor's protocol ID
- 25-07-0995
- Status last verified
- Dec 2025
- First submitted
- 14 Jul 2025
- Last updated
- 5 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectivity and Safety of GB20 Acupoint Pharmacopuncture With Lidocaine 2% on Migraine Patients : Study on Head Pain Characteristic and MIDAS-Ina Score
- ClinicalTrials.gov ID
- NCT07067853
- Acronym / sponsor ID
- 25-07-0995
- Conditions
- Migraine
- Keywords
- Migraine, Acupuncture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- 15 Dec 2025 (actual)
- First posted
- 16 Jul 2025 (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.
The goal of this clinical trial is to learn if 2% Lidocaine pharmacopuncture at the GB20 acupoint can effectively and safely treat migraine in adult patients. The main questions it aims to answer are:
- Does 2% Lidocaine pharmacopuncture at GB20 reduce the frequency of migraine attacks more than 40mg propranolol?
- Does 2% Lidocaine pharmacopuncture at GB20 reduce the duration of migraine attacks more than 40mg propranolol?
- Does 2% Lidocaine pharmacopuncture at GB20 reduce the intensity of migraine pain more than 40mg propranolol?
- Does 2% Lidocaine pharmacopuncture at GB20 improve MIDAS-Ina scores more than 40mg propranolol?
- Is 2% Lidocaine pharmacopuncture at GB20 more effective in improving bothersome migraine symptoms compared to 40mg propranolol?
- What is the incidence of side effects of 2% Lidocaine pharmacopuncture at GB20 in migraine patients?
Researchers will compare a pharmacopuncture group to a conventional medication group (propranolol) to see if pharmacopuncture works as an effective and safe alternative treatment for migraine patients.
Participants will:
- In the pharmacopuncture group, receive weekly injections of 0.5cc of 2% Lidocaine at the GB20 acupoint (bilaterally) for four weeks. These injections will be guided by ultrasonography.
- In the medication group, receive 20mg propranolol tablets twice daily for 28 days.
- Be provided with 500mg Paracetamol tablets as abortive therapy for acute migraine attacks.
- Use the 'Guardian Headache Diary' application to record migraine attack data (frequency, duration, intensity) for two months.
- Complete the MIDAS-Ina questionnaire at the beginning of the study, at the end of week 4, and at the end of week 8.
Side effects will be monitored and recorded throughout the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The intervention group will receive pharmacopuncture, while the control group will receive propranolol tablets
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Device: Lidocaine 2 % PharmacopunctureInjection of 0.5mL Lidocaine 2% solution into GB20 acupuncture point, both sides every week for 4 week |
| Control Group | Active comparator | Drug: propranolol 20mgPropranolol 20mg, twice daily for 28 day / 4 week |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Diagnosed with migraine
- Minimum of 3 days of migraine attacks in 1 month
- Willing to participate until the study concludes
Key exclusion criteria (7 listed)
- Headache with other known cause (e.g. head trauma, cancer, hemorrhagic stroke)
- Inaccessible GB20 acupuncture point (scar tissue, infection, open wound, etc)
- History of heart disease and/or asthma
- History of Hypersensitivity with propranolol and/or lidocaine
- History of acupuncture treatment 3 month prior to 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 |
|---|---|---|
| Lidocaine 2 % PharmacopunctureInjection of 0.5mL Lidocaine 2% solution into GB20 acupuncture point, both sides every week for 4 week | Device | Intervention Group |
| propranolol 20mgPropranolol 20mg, twice daily for 28 day / 4 week | Drug | Control Group |
Primary outcome
Frequency of migraine attacks
Time frame: Before therapy, week 4, week 8
Frequency of migraine attacks in 1 month
Duration of migraine attacks
Time frame: Before therapy, week 4, week 8
Duration of migraine attacks, counted in hour
Intensity of migraine attacks
Time frame: Before therapy, week 4, week 8
intensity of migraine attacks, measured with numeric rating scale from 1 to 10
Migraine Disability Assessment Test - Indonesian Language (MIDAS-Ina) Score
Time frame: Before therapy, week 4, week 8
Disability caused by migraine will be assessed with Migraine Disability Assessment Test - Indonesian Language (MIDAS-Ina), a 5-question questionnaire with a minimum score of 0 and maximum score of 450. Higher score means worse outcome.
Bothersome Symptom Improvement
Time frame: week 4, week 8
Improvement of bothersome symptoms, measured as improved or not improved
Adverse Event Related to Intervention
Time frame: immediately post-intervention until 8 weeks
adverse event happening after intervention is given, including pain, infection, skin rash/irritation will be recorded and monitored
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 5 Jan 2026.
- Individual participant dataSharing planned: Undecided
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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.
Komite Etik Penelitian Kesehatan FKUI-RSCM principal investigator
Health Research Ethics Commitee - Faculty of Medicine Universitas Indonesia and Dr. Cipto Mangunkusumo National Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lidocaine 2 % Pharmacopuncture and propranolol 20mg in people with Migraine, run by Universitas Indonesia at 1 site 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 3 inclusion and 7 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 5 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Frequency of migraine attacks (time frame: Before therapy, week 4, week 8). The study lists 6 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 5 Jan 2026.