Can an ancient herbal capsule boost antidepressant power?

NCT ID NCT05361330

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
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Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 16, 2026 · Last updated Sep 17, 2026 · Updated 1 time

Summary

Researchers are studying whether adding a Chinese herbal capsule called Shuganjieyu to the antidepressant fluoxetine helps ease depression symptoms more than fluoxetine alone. The trial enrolls 160 adults with depression, ages 18 to 65, who score at least 18 on a standard depression rating scale. Participants receive either the herbal capsule plus fluoxetine or a placebo plus fluoxetine for eight weeks, with an optional longer treatment period. Doctors track changes in depression and anxiety scores to compare the two approaches.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Shuganjieyu capsule, a Chinese herbal medicine, added to the antidepressant fluoxetine
What this could lead to
If it works, doctors could have another option for people whose depression does not fully respond to a standard antidepressant alone.
What could go wrong
The trial is mid-sized and tests a herbal add-on, so results may not hold up in larger studies. Herbal products can interact with other medicines, and depression treatment often varies from person to person.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

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

160 people

The number who actually took part.

Started

May 2022

Finished

May 2024

Lead sponsor

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

18 to 65 years

Sex

Anyone

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. In line with the diagnostic criteria for depression of Diagnostic and Statistical Manual of Mental Disorders (5th edition) (DSM-5); 2. Age: 18-65 (including 18 and 65), gender unlimited; 3. Hamilton Rating Scale for Depression (HAMD-17) score≥18 in the screening period, and the 13th score≥2; 4. For women of childbearing age, pregnancy test must be negative and not in lactation. The contraception measure must be accepted by the Investigators. Participants should agree to maintain this measure throughout the whole process; 5. Sign the informed consent form voluntarily and agree to participate in all visits, examinations and treatment as required by the trial protocol. Exclusion Criteria: 1. Treatment-resistant depression (patients with poor clinical efficacy of antidepressants with two or more different mechanisms after sufficient and full course of treatment); 2. Patients who meet DSM-5 diagnostic criteria for other mental disorders (such as schizophrenia pedigree and other mental disorders, bipolar and related disorders, anxiety disorders, obsessive-compulsive and related disorders, somatic symptoms and related disorders); 3. Depression caused by psychoactive drugs; 4. Patients with severe suicide (HAMD-17 suicide score≥3) and injury tendency; 5. Patients with serious or unstable cardiovascular, cerebrovascular, liver, kidney, endocrine, digestive and blood diseases; 6. Depressive episodes secondary to other mental diseases or somatic diseases at an active stage; 7. ALT and AST values in the liver function examination are more than double the upper limit of reference value, or Scr value is above the upper limit of reference value; 8. Patients with a history of endocrine diseases such as hyperthyroidism and hypothyroidism who are currently active; 9. Patients who had undergone psychiatric surgery or electroconvulsive therapy in the past three months; 10. Anyone with an allergic constitution known or suspected to have an allergic history to Hypericum perforatum L., Eleutherococcus senticosus and Fluoxetine; 11. Those who have previously failed Shuganjieyu capsule or Fluoxetine treatment; 12. Women in pregnancy or lactation period. Women who plan to get pregnant during the study and within six months; 13. Patients with psychoactive substance abuse or dependence in the past 12 months; 14. Long-term use of caffeine and nicotine; 15. Patients who have received or are receiving any other clinical trial drug treatment within three months before the trial; 16. Patients who are taking drugs that interfere with the efficacy evaluation of the investigational drugs, and drugs that are forbidden to be used in combination with the test drugs. Patients who have received antidepressant drugs for systematical treatment within 4 weeks; 17. Those who are regarded as unsuitable by investigators for 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.

Contacts and locations

Locations

  • First Hospital, Shanxi Medical University

    Taiyuan, Shanxi, 030000, China

  • Institute of Mental Health, Peking University Sixth Hospital

    Beijing, China

  • Nanjing Brain Hospital, Nanjing Medical University

    Nanjing, Jiangsu, 210000, China

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