A single-center, randomized, double-blind, dose-controlled clinical trial of Xiegan Qingxin Formula in the treatment of mild to moderate generalized anxiety disorder

Authors
Category Primary study
Registry of TrialsInternational Traditional Medicine Clinical Trial Registry
Year 2026
INTERVENTION: Experimental Group:Standard dosage of Xiegan Qingxin Decoction granules.;Control Group:Low‐dose Xiegan Qingxin Decoction granules (Chinese herbal ingredients content at 10% of the experimental group); CONDITION: Generalized Anxiety Disorder PRIMARY OUTCOME: Hamilton Anxiety Scale Score; SECONDARY OUTCOME: Pittsburgh Sleep Quality Inde XScore;Clinical Global Impressions–Severity Scale Score;Clinical Global Impression‐Improvement Scale Score;Quality of Life (QOL) Score;TCM syndrome score;Sleep medications, types of anxiety medications, frequency of medication intake, dosage of medication; INCLUSION CRITERIA: (1) Meets the diagnostic criteria for generalized anxiety disorder according to DSM‐5 (Western medicine); (2) Meets the diagnostic criteria for liver meridian with hyperactive fire syndrome (Traditional Chinese Medicine); (3) Aged 18 to 70 years old (inclusive), with no restriction on gender; (4) HAMA score is between 14 and 29, with a score of at least 2 on item 1 (anxious mood); (5) Voluntarily participates in this clinical trial, can cooperate with the researchers, and signs the informed consent form.
Epistemonikos ID: 20000994fa999b573548a8948e0bf016995a0fa2
First added on: Aug 08, 2026