Efficacy and safety of the Xiaoyao pill for improving the clinical symptoms of stagnation of liver qi (chi) and spleen deficiency

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2020
INTERVENTION: The 108 eligible participants will be allocated to the experimental or placebo arm based on a random lottery. Participants will be required to take the medicine twice daily for four consecutive weeks and the dosage is 9 g twice a day. The experimental intervention is the Xiaoyao pill. Xiaoyao pills are water honey pills (Z20013060) produced by Jiuzhitang Co., Ltd. The appearance and specifications of the placebo are the same as Xiaoyao pills. CONDITION: Mild to moderate depression with symptoms of stagnation of liver qi and spleen deficiency ; Mental and Behavioural Disorders ; Depressive episode PRIMARY OUTCOME: Depression with symptoms of stagnation of liver qi and spleen deficiency, assessed using the Hamilton Depression scale (HAMD) at baseline, 1 week, 2 weeks and 4 weeks SECONDARY OUTCOME: Overall health measured using TCM symptoms Scale at baseline, 1 week, 2 weeks and 4 weeks INCLUSION CRITERIA: 1. Meet the Diagnostic Statistics Manual of Mental Disorders (DSM‐5) regarding the diagnosis of mild to moderate depression 2. A score between 20 and 35 on HAMD 3. Meet the TCM criteria of liver depression and spleen deficiency syndrome 4. Aged between 16 ‐ 18 years old, both genders 5. Patients agree to participate in this trial and assign the informed consent 6. Capable of reading and follow‐up treatment, and permanently live locally
Epistemonikos ID: 3bb2948ec87a3a672a00934f27c35c2723679804
First added on: Aug 24, 2024