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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:
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:
Side effects will be monitored and recorded throughout the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group | Experimental | Injection of 0.5mL Lidocaine 2% solution into GB20 acupuncture point, both sides every week for 4 week |
|
| Control Group | Active Comparator | Propranolol 20mg, twice daily for 28 day / 4 week |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lidocaine 2 % Pharmacopuncture | Device | Injection of 0.5mL Lidocaine 2% solution into GB20 acupuncture point, both sides every week for 4 week |
|
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of migraine attacks | Frequency of migraine attacks in 1 month | Before therapy, week 4, week 8 |
| Duration of migraine attacks | Duration of migraine attacks, counted in hour | Before therapy, week 4, week 8 |
| Intensity of migraine attacks | intensity of migraine attacks, measured with numeric rating scale from 1 to 10 | 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. | Before therapy, week 4, week 8 |
| Bothersome Symptom Improvement | Improvement of bothersome symptoms, measured as improved or not improved | 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 | immediately post-intervention until 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Komite Etik Penelitian Kesehatan FKUI-RSCM | Health Research Ethics Commitee - Faculty of Medicine Universitas Indonesia and Dr. Cipto Mangunkusumo National Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitas Indonesia | Jakarta Pusat | DKI Jakarta | 10430 | Indonesia |
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D011433 | Propranolol |
| ID | Term |
|---|---|
| D050198 | Phenoxypropanolamines |
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
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The intervention group will receive pharmacopuncture, while the control group will receive propranolol tablets
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| propranolol 20mg | Drug | Propranolol 20mg, twice daily for 28 day / 4 week |
|
| D009422 | Nervous System Diseases |
| D009930 |
| Organic Chemicals |
| D020005 | Propanols |
| D000588 | Amines |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |