Can an ancient herbal remedy ease depression? a large Real-World trial investigates
NCT ID NCT07785284
First seen Aug 25, 2026 · Last updated Sep 09, 2026 · Updated 3 times
Summary
This study investigates whether Shugan Jieyu Capsules, a traditional Chinese herbal medicine, can effectively treat depression of varying severity in everyday clinical practice. Researchers will follow 400 patients aged 13-65 with depression, giving them the capsules alone or alongside standard antidepressants, and track their symptoms over 24 weeks. The goal is to see how well the herbal treatment works and whether it is safe, potentially informing how traditional and Western medicine can be combined for better depression care.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Shugan Jieyu Capsules, a traditional Chinese herbal medicine, tested alone or combined with standard antidepressants (SSRIs)
- What this could lead to
- If effective, this could support integrating a traditional Chinese herbal remedy into standard depression care, potentially offering a gentler or complementary option for patients.
- What could go wrong
- This is a real-world observational study, not a controlled trial, so results may be influenced by other factors. The herbal capsules may not outperform existing treatments, and side effects or interactions are possible.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 400 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Jun 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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13 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Meet the diagnostic criteria for depression according to the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5); 2. Aged 13-65 years (inclusive), male or female; 3. No antidepressants taken within at least 14 days before screening (patients who have received fluoxetine treatment must have discontinued it for at least 28 days before screening); 4. Voluntarily sign the informed consent form and comply with all study visits, examinations, and treatments as required by the protocol. Exclusion Criteria: 1. Treatment-resistant depression (poor clinical response to adequate doses and durations of two or more antidepressants with different mechanisms, or poor clinical response to adequate doses and durations of antidepressant TCMs) or depression induced by psychoactive substances; 2. Patients who meet the diagnostic criteria for other mental disorders in the DSM-5 (such as schizophrenia spectrum disorders, bipolar disorder); 3. Patients with serious suicidal tendencies (HAMD-17 item 3 score ≥ 3) or homicidal tendencies; 4. Patients with severe or unstable cardiovascular, cerebrovascular, hepatic, renal, endocrine, digestive, hematological, or other medical conditions; 5. Known or suspected history of allergy to Hypericum perforatum or Eleutherococcus senticosus; 6. Pregnant or breastfeeding women; 7. Patients currently receiving treatment with any other investigational drug; 8. Other patients who are not suitable for participation in this clinical trial.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Institute of Mental Health, Peking University Sixth Hospital
Beijing, 100191, China