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NCT07872943
Treatment of Tension-type Headache by Zhixuan Analgesic Tablets
Conditions: Frequent Episodic Tension-Type Headache
Sex: All
Ages: 18 Years – 60 Years
Healthy volunteers: No
Phase: PHASE4
Enrollment: 212
Sponsor: Tongji Hospital
Location: Tongji Hospital Wuhan Hubei
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
Eligibility Criteria
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 \
Source: ClinicalTrials.gov (NCT07872943). StuddyBuddy aggregates publicly available trial information.