Clinical Trials Directory

Trials / Completed

CompletedNCT07067853

Effectivity and Safety of GB20 Acupoint Pharmacopuncture With Lidocaine 2% on Migraine Patients

Effectivity and Safety of GB20 Acupoint Pharmacopuncture With Lidocaine 2% on Migraine Patients : Study on Head Pain Characteristic and MIDAS-Ina Score

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
30 (actual)
Sponsor
Indonesia University · Academic / Other
Sex
All
Age
18 Years – 59 Years
Healthy volunteers
Not accepted

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

TypeNameDescription
DEVICELidocaine 2 % PharmacopunctureInjection of 0.5mL Lidocaine 2% solution into GB20 acupuncture point, both sides every week for 4 week
DRUGpropranolol 20mgPropranolol 20mg, twice daily for 28 day / 4 week

Timeline

Start date
2025-09-01
Primary completion
2025-12-01
Completion
2025-12-15
First posted
2025-07-16
Last updated
2026-01-05

Locations

1 site across 1 country: Indonesia

Source: ClinicalTrials.gov record NCT07067853. Inclusion in this directory is not an endorsement.