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

Xiaoyao pill for the treatment of stagnation of liver qi and spleen deficiency with depression: a multi-center randomized controlled double-blind trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN12746343
Enrollment
108
Registered
2020-09-24
Start date
2020-10-30
Completion date
Unknown
Last updated
2024-06-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mild to moderate depression with symptoms of stagnation of liver qi and spleen deficiency Mental and Behavioural Disorders Depressive episode

Interventions

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

Sponsors

Beijing University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: 1. Bipolar depression,treatment-resistant depression and severe suicidal risk 2. History of bipolar disorder, schizophrenia, obvious psychotic symptoms and depression disorder caused by non-addictive substances 3. Combine with severe cardiovascular diseases, cerebrovascular diseases, hepatic diseases, renal diseases, hematological disease, cancer, or other severe primary diseases 4. Pregnant or lactating women 5. Inability to finish the compliance test, judge the efficacy and have complete data 6. Involved with any other clinical trial at the time of consent

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Overall health measured using TCM symptoms Scale at baseline, 1 week, 2 weeks and 4 weeks

Countries

China

Contacts

Public ContactZhe Xue
xuezhesanctity@163.com+86 (0)10-64286656

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 13, 2026