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Clinical Observation of Toutong Jieyu Tongluo Formula in Treating Primary Chronic Headache with Liver Qi Stagnation and Phlegm-Blood Stasis Obstructing the Collaterals Pattern

Clinical Observation of Toutong Jieyu Tongluo Formula in Treating Primary Chronic Headache with Liver Qi Stagnation and Phlegm-Blood Stasis Obstructing the Collaterals Pattern

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025002493
Enrollment
Unknown
Registered
2025-12-24
Start date
2025-01-13
Completion date
Unknown
Last updated
2026-06-01

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

Conditions

Primary Chronic Headache

Interventions

Chinese Medicine Group: Toutong Jieyu Tongluo Formula
Western Medicine Group: Flunarizine Hydrochloride Capsules (5 mg per capsule), 1 capsule nightly.

Sponsors

Xinhua Hospital of Zhejiang Province
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Patients who meet all of the following criteria are eligible for inclusion in this trial: (1) Meet the diagnostic criteria for primary chronic headache according to the International Classification of Headache Disorders, 3rd edition (ICHD-III) established by the International Headache Society in 2018, including chronic migraine, chronic tension-type headache, new daily persistent headache, and hemicrania continua; (2) Conform to the syndrome differentiation standard for headache with liver qi stagnation and phlegm-blood stasis obstructing the collaterals; (3) Aged between 18 and 65 years; (4) Normal communication ability, comprehension capacity, and conscious state; (5) The patient and their family members have been informed and provided consent, and have signed the informed consent form.

Exclusion criteria

Exclusion criteria: Patients meeting any of the following criteria will be excluded from the trial: (1) Those with secondary chronic headache caused by other etiologies; (2) Those with a history of allergy to the investigational drugs or contraindications to high-frequency or low-frequency rTMS therapy; (3) Those who have taken antidepressants, anti-anxiety medications, or other psychotropic drugs within the recent 2 weeks; (4) Those complicated with malignant tumors, hematological system diseases, functional impairment of vital organs, or major mental disorders; (5) Women who are pregnant, lactating, or planning to become pregnant within the next 3 months; (6) Those with traumatic brain injury or focal neurological deficits; (7) Those who have participated in other clinical trials within 3 months prior to this study, or are deemed by the investigators as unsuitable for participation for other reasons; (8) Those with incomplete data (e.g., general information including family history, personal history, past medical history, medication history, etc.); (9) Those who refuse to undergo examinations related to this study; (10) Other circumstances deemed by the investigators as unsuitable for participation.

Design outcomes

Primary

MeasureTime frame
Number of Headache Attacks;Headache Index;

Secondary

MeasureTime frame
Headache Associated Symptom Score;TCM score;Dependence on analgesics;

Countries

China

Contacts

Public ContactBin Xu

Xinhua Hospital of Zhejiang Province

Xubin2008.love@163.com13858088545

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Jun 11, 2026