Zhixuan Analgesic Tablet for frequent tension-type headaches

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, double-blind, placebo-controlled study will enroll adults aged 18-60 with frequent episodic tension-type headaches. Participants will be randomized to Zhixuan Analgesic Tablet or a matching placebo for 12 weeks, with a 4-week screening period to confirm eligibility. The trial evaluates whether the active tablet lowers the number of headache days per 4-week interval, reduces reliance on acute analgesics, and improves overall headache burden and daily function, while monitoring safety. Background traditional Chinese medicine approaches are used within a modern randomized framework to generate high-quality evidence on efficacy and safety.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Aged 18-60 years, male or female.
2. Meets diagnostic criteria for frequent episodic tension-type headache, with ≥4 headache days per month on average over the past 3 months (and ≥4 but \<15 headache days during the 4-week initial screening period).
3. TCM syndrome differentiation is primarily Liver-Yang Ascending Syndrome and/or Static Blood Obstructing the Collaterals Syndrome.
4. Provides informed consent.

Exclusion Criteria:

1. Headache is better explained by a headache type other than tension-type headache (including medication-overuse headache). Presence of more than one migraine attack per month.
2. Has received headache-related treatments within the last 4 weeks (e.g., medications such as amitriptyline, venlafaxine, duloxetine, mirtazapine; potentially interfering antidepressants or sleep-improving drugs like flupentixol and melitracen tablets, diazepam; non-pharmacological headache treatments like acupuncture, neuroregulation; Chinese herbal medicines or formulas with known efficacy for headache; or any other treatments that may aggravate or alleviate headaches). Potential participants currently on such treatments may be eligible after discontinuing them for a full 8 weeks.
3. Inability to cooperate with scale assessments due to factors such as low education level, visual or hearing impairment, dementia, etc.
4. Presence of severe comorbid diseases that may interfere with headache assessment or treatment. These include: severe or greater anxiety/depression (according to the Hospital Anxiety and Depression Scale - HADS) and severe sleep disorder (according to the Pittsburgh Sleep Quality Index - PSQI), psychosis, epilepsy, intracranial space-occupying lesions, moderate or severe hepatic or renal insufficiency, uncontrolled hypertension; gastrointestinal diseases affecting drug absorption and metabolism, etc.
5. Known allergy or contraindication to the study drug.
6. Alcohol abuse or other substance dependence.
7. Women who are planning pregnancy, pregnant, breastfeeding, or women of childbearing potential not using contraception.

Where it's running

• Tongji Hospital
  Wuhan, Hubei, China Recruiting

Study contacts

• Study coordinator: Wensheng Qu, Doctor
• Email: qws0309@163.com
• Phone: +8618572815759

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.