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Effect of Xuefu Zhuyu Oral Liquid on Tension-Type Headache with Qi-Stagnation and Blood-Stasis Pattern: a Randomized Controlled Trial and an Observational Study for Tension-Type Headache with non Qi-Stagnation and Blood-Stasis Pattern

Postmarket Research for Two Classical Formulae of Chinese Medicine Based on an Overarching Design

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900026716
Enrollment
Unknown
Registered
2019-10-19
Start date
2019-11-01
Completion date
Unknown
Last updated
2021-09-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tension-type headache

Interventions

Sponsors

The Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: RCT 1. TTH should be at least more than 1 year, at least 2 days per month (unlimited frequency), and at least one attack of TTH should be more than 4 hours; 2. Visual analog scale (VAS) score >= 3cm; 3. The first attack of TTH was before 50 years old; 4. Aged 18-65 years; 5. TCM syndrome differentiation is Qi stagnation and blood stasis; 6. Sign informed consent. Observational study TCM syndrome differentiation is non Qi stagnation and blood stasis

Exclusion criteria

Exclusion criteria: RCT 1. Migraine; 2. The results of CT scan and TCD in half a year proved to be secondary headache. 3. Combined with cardiovascular, liver, kidney and hematopoietic system and other serious primary diseases and mental disorders (schizophrenia, epilepsy, alcoholism, anorexia, etc.) or major neuropsychiatric history, including moderate arrhythmia, chronic obstructive pulmonary disease, acute or subacute severe hepatitis, chronic renal failure, diabetes, cancer, schizophrenia and other diseases. 4. Laboratory examination showed that the increase of ALT or AST was more than 2 times of the upper limit of normal value, and the increase of creatinine was more than 1.5 times of the upper limit of normal value. 5. Suffering from other severe pain diseases, such as cancer pain; 6. Patients with self rating Anxiety Scale (SAS) greater than 59 or self rating Depression Scale (SDS) greater than 62, or patients with other mental diseases or severe cognitive disorders; 7. May be allergic to the test drug; 8. Planned pregnancy, pregnant and lactating women; 9. Those who are participating in clinical trials of other drugs or have participated in other clinical trials within one month. Observational study 1. Migraine; 2. The results of CT scan and TCD in half a year proved to be secondary headache 3. Planned pregnancy, pregnant and lactating women; 4. Those who are participating in clinical trials of other drugs or have participated in other clinical trials within one month.

Design outcomes

Primary

MeasureTime frame
Difference of average pain intensity before and after treatment;

Secondary

MeasureTime frame
Area-under-the headache curve;Fruqency of headache;Total time of headache;A questionnaire of Symptoms including tongue and pulse of traditional Chinese medicine;EQ-5D-5L;the usage of painkillers;Global evaluation of medication;health economic indexes;

Countries

China

Contacts

Public ContactZehuai Wen

The Second Affiliated Hospital of Guangzhou University of Chinese medicine (Guangdong Provincial Hospital of Chinese Medicine)

13903008091@139.com+86 20-81887233-35837

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 19, 2026