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RECRUITING

NCT07872943

PHASE4

Treatment of Tension-type Headache by Zhixuan Analgesic Tablets

Sponsor: Tongji Hospital

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to learn if Zhixuan Analgesic Tablet works to treat frequent episodic tension-type headache in adults aged 18-60 years. It will also learn about the safety of Zhixuan Analgesic Tablet. The main questions it aims to answer are: * Does Zhixuan Analgesic Tablet reduce the number of headache days compared with placebo within each 4-week interval during the 12-week treatment period? * What medical problems do participants have when taking Zhixuan Analgesic Tablet? Researchers will compare Zhixuan Analgesic Tablet (4 tablets per dose, 3 times per day) to a matching placebo (a look-alike tablet that contains no active drug) to see if Zhixuan Analgesic Tablet reduces overall headache burden - including headache days, the amount of acute analgesic medication needed, the duration and severity of headaches, and the impact of headache on daily life. Participants will: * Take Zhixuan Analgesic Tablet or a matching placebo 3 times per day for 12 weeks * Keep a headache diary to record headache days, headache duration and severity, and any acute analgesic medication used * Attend scheduled clinic visits for check-ups and safety monitoring * Complete the Headache Impact Test (HIT-6) and a global self-assessment of treatment effectiveness at the end of the treatment period

Official title: Randomized, Double-blind, Placebo-controlled, Multi-center Study on the Treatment of Tension-type Headache With Zhixuan Analgesic Tablets

Key Details

Gender

All

Age Range

18 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

212

Start Date

2026-01-01

Completion Date

2027-08-31

Last Updated

2026-10-14

Healthy Volunteers

Conditions

Frequent Episodic Tension-Type Headache

Interventions

DRUG

Zhixuan Analgesic Tablet

Zhixuan Analgesic Tablet (4 tablets/time, 3 times/day)

DRUG

Placebo

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.

Locations (1)

Tongji Hospital

Wuhan, Hubei, China