Treatment of Tension-type Headache by Zhixuan Analgesic Tablets

Authors
Category Primary study
Registry of TrialsClinicalTrials.gov
Year 2026
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
Epistemonikos ID: 82458c6d59126bd10d37782fbcbff462fbe63254
First added on: Oct 15, 2026