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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04509141
Other study ID # medical acupuncture 2020
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 5, 2019
Est. completion date August 30, 2019

Study information

Verified date August 2020
Source Indonesia University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Migraine is a primary headache attack, specific, paroxysmal, with or without aura, with subjective manifestations both before and after the attack, a chronic type of headache with symptoms of recurrence, attacks at productive age and can cause a decrease in work productivity up to 80%, so that it will affect the quality of life, economic life and education globally which leads to losses for migraine sufferers and institutions where migraine sufferers attend school, work and in the lives of sufferers' families.


Description:

Migraine is a primary headache attack, specific, paroxysmal, with or without aura, with subjective manifestations both before and after the attack, a chronic type of headache with symptoms of recurrence, attacks at productive age and can cause a decrease in work productivity up to 80%, so that it will affect the quality of life, economic life and education globally which leads to losses for migraine sufferers and institutions where migraine sufferers attend school, work and in the lives of sufferers' families. With the high prevalence and disability rates for migraine sufferers, on the other hand, the right treatment for migraine has not yet been obtained to the maximum, it is necessary to deepen the treatment and prevention of migraine is needed, and until now there has been no definitive cure, both for prevention and treatment, so it is necessary to develop therapies that can provide more accurate relief for migraine sufferers. The purpose of this study is to assess the success in managing migraine in reducing the frequency of attacks, reducing the intensity of attacks and reducing the duration of attacks from weeks 0, 4 to 8


Recruitment information / eligibility

Status Completed
Enrollment 34
Est. completion date August 30, 2019
Est. primary completion date August 7, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 19 Years to 50 Years
Eligibility Inclusion Criteria:

- subjects aged 19-50 years

- subjects with history of clinical diagnosis of migraine (interictal period)

- signed research approval forms, and were willing to take the study to completion.

Exclusion Criteria:

- subjects with pregnancy,

- lesions, wounds, infections and suffering from malignant diseases or tumor and thrombophlebitis in the area at the selected acupuncture point

- increasing liver function three times above normal values.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
acupuncture
acupuncture points used were EXHN5 Taiyang, GB20 Fengchi, TE5 Waigun, GB41 Zulinqi

Locations

Country Name City State
Indonesia University of Indonesia Jakarta Pusat DKI Jakarta

Sponsors (1)

Lead Sponsor Collaborator
Indonesia University

Country where clinical trial is conducted

Indonesia, 

Outcome

Type Measure Description Time frame Safety issue
Primary frequency Manual acupuncture interventions can reduce the frequency of migraine attacks better than the preventive pharmacological valproic acid at week 4
Primary duration Manual acupuncture interventions can reduce the duration of migraine attacks better than the preventive pharmacological valproic acid at week 4
Primary intensity Manual acupuncture interventions can reduce the change from Baseline in pain scores on the Visual Analog Scale of migraine attacks better than the preventive pharmacological valproic acid at week 4
Primary frequency Manual acupuncture interventions can reduce the frequency of migraine attacks better than the preventive pharmacological valproic acid at week 8
Primary duration Manual acupuncture interventions can reduce the duration of migraine attacks better than the preventive pharmacological valproic acid at week 8
Primary intensity Manual acupuncture interventions can reduce the change from Baseline in pain scores on the Visual Analog Scale of migraine attacks better than the preventive pharmacological valproic acid at week 8
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