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A protocol of randomized controlled trial for Modified Xiaoyao Powder in the treatment of chronic obstructive pulmonary disease combined mild to moderate depression

A protocol of randomized controlled trial for Modified Xiaoyao Powder in the treatment of chronic obstructive pulmonary disease combined mild to moderate depression

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2000004186
Enrollment
Unknown
Registered
2020-09-30
Start date
2020-12-01
Completion date
Unknown
Last updated
2023-02-20

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

Conditions

depression

Interventions

Experimental group:Modified Xiaoyao Powder
Control group:Modified Xiaoyao Powder placebo

Sponsors

Hospital of Chengdu University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 65 years men and women; 2. Patients who had received a diagnosis of COPD combined mild to moderate depression (HAMD-17 score 7 to 24) and meet the syndrome of stagnation of liver qi of depression; 3. The course of depression does not exceed 3 months; 4. The patients has not taken antidepressants in the past 1 month; 5. Agree to participate and sign an informed consent form.

Exclusion criteria

Exclusion criteria: 1. A history of a suicide attempt treament-resistant depression, and familial mental illness; 2. Had a recent history of other acute or chronic significant clinical manifestations medical conditions; 3. A history of bipolar disorder, schizophrenia, or schizo affective disorder; 4. Patients who cannot actively cooperate with the treatment.

Design outcomes

Primary

MeasureTime frame
the change in the HAMD-17 score from baseline;

Secondary

MeasureTime frame
a reduction of more than 50% from baseline in the HAMD-17 score;the change from baseline in CAT score;the change from baseline in mMRC score;the frequency of hospitalizations;the number of exacerbations;

Countries

China

Contacts

Public ContactKeling Chen

Chengdu University of Traditional Chinese Medicine

1079767304@qq.com+86 13982228521

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026