Effectivity and Safety of GB20 Acupoint Pharmacopuncture With Lidocaine 2% on Migraine Patients
NCT07067853 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2026-01-05
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 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.
Conditions
Interventions
- DEVICE
-
Lidocaine 2 % Pharmacopuncture
Injection of 0.5mL Lidocaine 2% solution into GB20 acupuncture point, both sides every week for 4 week
- DRUG
-
propranolol 20mg
Propranolol 20mg, twice daily for 28 day / 4 week
Sponsors & Collaborators
-
Indonesia University
lead OTHER
Principal Investigators
-
Komite Etik Penelitian Kesehatan FKUI-RSCM · Health Research Ethics Commitee - Faculty of Medicine Universitas Indonesia and Dr. Cipto Mangunkusumo National Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- FACTORIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 59 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-09-01
- Primary Completion
- 2025-12-01
- Completion
- 2025-12-15
Countries
- Indonesia
Study Locations
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