Generalized Anxiety DisorderPhase 3NCT05772104
Clinical Trial of Shugan Jieyu Capsule in Generalized Anxiety Disorder
A Phase 3 study testing Shugan Jieyu Capsules in people with Generalized Anxiety Disorder, run by Sichuan Jishengtang Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
This is a randomized double-blind placebo-controlled phase 3 clinical trial to further validate the effectiveness and safety of Shugan Jieyu Capsules in treating generalized anxiety disorder. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Generalized Anxiety Disorder
- What is being tested?
- Shugan Jieyu Capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 495 participants
- Where
- 1 siteChina
- Study dates
- 17 Apr 2023to 1 Jun 2025
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary diagnosis of generalized anxiety disorder (GAD) as per Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) as confirmed by the MINI at Screening, The duration of illness must be ≥ 6 months；
- Age 18-65 years old；
- Hamilton Anxiety Rating Scale (HAM-A) Total Score of ≥ 14 at both Screening and Baseline，Anxious Mood (item 1) score ≥2；
- Clinical Global Impression of Severity Scale (CGI-S) score of ≥ 3 at both Screening and Baseline
- The TCM syndrome is liver Qi stagnation and spleen deficiency syndrome.
Who cannot join
- Diagnosed with a psychiatric disorder other than GAD that meets DSM-5 criteria within 6 months prior to screening；
- Alcohol or drug abuse or dependence in the 6 months prior to screening, or urine positive for multiple drugs combined at screening
- Hamilton Depression Rating Scale (HAMD-17) Total Score of > 17 at Screening or Baseline，or Depressive Mood (item 1) score ≥2；
- Patients with Severe Insomnia.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Anding Hospital Affiliated to Capital Medical University
Beijing
Gang Wang, +8613911695727, adgangwang@163.com
About this study
Official title: A Multi-center, Randomized, Double-Blind Clinical Trial of Shugan Jieyu Capsule in Generalized Anxiety Disorder
This is a randomized double-blind placebo-controlled phase 3 clinical trial to further validate the effectiveness and safety of Shugan Jieyu Capsules in treating generalized anxiety disorder.
Read the detailed description
This trial was a multi-center, randomized, double-blind, two-stage clinical trial in patients with generalized anxiety disorder (TCM differentiated as liver Qi stagnation and spleen deficiency syndrome), consisting of a exploratory study(stage 1) and a confirmatory study(stage 2).
In stage 1, 120 subjects were enrolled and randomly assigned to high-dose group, low-dose group and placebo group at a ratio of 1:1:1.
In stage 2, 495 subjects were randomly assigned to the experimental and placebo groups at a ratio of 1:1.
- Conditions
- Generalized Anxiety Disorder
- Being tested
- Shugan Jieyu Capsules, Shugan Jieyu Capsules Placebo
- Medical subject headings
- Generalized Anxiety Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shugan Jieyu CapsulesDrug
Oral, 4 Capsules, BID
Shugan Jieyu Capsules PlaceboDrug
Drug: Shugan Jieyu Capsules Placebo, Oral，4 capsules，BID
Drug: Placebo, Oral, 1 capsule, BID
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Shugan Jieyu Capsules | Experimental | Participants received Shugan Jieyu Capsules 4 capsules,BID,once in the morning and once in the evening, at an interval of more than 8 hours, for up tp 12 weeks. Receives: Drug: Shugan Jieyu Capsules |
| Experimental: Shugan Jieyu Capsules Placepo | Placebo comparator | Participants received Shugan Jieyu Capsules Placebo 4 capsules,BID,once in the morning and once in the evening, at an interval of more than 8 hours, for up tp 12 weeks. Receives: Drug: Shugan Jieyu Capsules Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in the HAM-A Total Score at Week 12
The Hamilton Anxiety Rating Scale (HAM-A) is a clinician-administered scale which consists of 14 items, each rated on a five point scale ranging from 0 (not present) to 4 (very severe). The highest possible score is 56, which represents the most severe form of anxiety; the lowest possible score is 0, which represents an absence of anxiety.
Measured: Change from Baseline to Week 12
Secondary outcomes (9)
Change From Baseline in the HAM-A Total Score at Week 2, 4, and 8
The Hamilton Anxiety Rating Scale (HAM-A) is a clinician-administered scale which consists of 14 items, each rated on a five point scale ranging from 0 (not present) to 4 (very severe). The highest possible score is 56, which represents the most severe form of anxiety; the lowest possible score is 0, which represents an absence of anxiety.
Measured: Change from Baseline to Week 2, 4, and 8
The Proportion of Subjects with HAM-A Total Score Reduction Rate ≥50% at week 2, 4, 8 and 12;
The Hamilton Anxiety Rating Scale (HAM-A) is a clinician-administered scale which consists of 14 items, each rated on a five point scale ranging from 0 (not present) to 4 (very severe). The highest possible score is 56, which represents the most severe form of anxiety; the lowest possible score is 0, which represents an absence of anxiety.
Measured: Change from Baseline to Week 2, 4, 8 and 12
The Proportion of Subjects with HAM-A Total Score ≤7 at week 2, 4, 8 and 12
The Hamilton Anxiety Rating Scale (HAM-A) is a clinician-administered scale which consists of 14 items, each rated on a five point scale ranging from 0 (not present) to 4 (very severe). The highest possible score is 56, which represents the most severe form of anxiety; the lowest possible score is 0, which represents an absence of anxiety.
Measured: Change from Baseline to Week 2, 4, 8 and 12
Change From Baseline in the HAM-A Mental Anxiety Score at Week 2, 4, 8 and 12
HAM-A Mental Anxiety Score was the sum of Items 1 to 6 and Item 14 and could have ranged from 0 to 28.
Measured: Change from Baseline to Week 2, 4, 8 and 12
Change From Baseline in the HAM-A Somatic Anxiety Score at Week 2, 4, 8 and 12
The HAM-A Somatic Anxiety Factor Score was the sum of Items 7 to 13 and could have ranged from 0 to 28.
Measured: Change from Baseline to Week 2, 4, 8 and 12
Change From Baseline in the The World Health Organization Quality of Life (WHOQOL)-BREF at Week 2, 4, 8 and 12
The scale evaluates the quality of life in four areas: physiology, psychology, social relations and environment.
Measured: Change from Baseline to Week 2, 4, 8 and 12
Change From Baseline in the Clinical Global Impression of Severity Scale (CGI-S) at Week 2, 4, 8 and 12
The CGI-S is measures the clinician's impression of a subject's current anxiety severity considering their total clinical experience with the patient population. This measure uses a 0-7 scale, with higher scores indicating greater anxiety severity.
Measured: Change from Baseline to Week 2, 4, 8 and 12
Change From Baseline in the Clinical Global Impression of Improvement Scale (CGI-I) at Week 2, 4, 8 and 12
CGI-I measured the clinician's perception of the participant's improvement at the time of assessment compared with the baseline. Scores could have ranged from 1 (very much improved) to 7 (very much worse).
Measured: Change from Baseline to Week 2, 4, 8 and 12
Change From Baseline in the Traditional Chinese Medicine Syndrome Score Scale at Week 2, 4, 8 and 12
TCM syndrome scale was used to evaluate the changes of TCM symptoms and signs before and after treatment.
Measured: Change from Baseline to Week 2, 4, 8 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2023
- Study start17 Apr 2023
- Primary completion28 Feb 2025 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Generalized Anxiety DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 495 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sichuan Jishengtang Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gang Wang, MD, Principal investigator, Beijing Anding Hospital Affiliated to Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05772104
- Sponsor's protocol ID
- KH109-CS01-CRP
- Status last verified
- Dec 2024
- First submitted
- 6 Mar 2023
- Last updated
- 18 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, Double-Blind Clinical Trial of Shugan Jieyu Capsule in Generalized Anxiety Disorder
- ClinicalTrials.gov ID
- NCT05772104
- Acronym / sponsor ID
- KH109-CS01-CRP
- Conditions
- Generalized Anxiety Disorder
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 495 participants (estimated)
- Lead sponsor
- Sichuan Jishengtang Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 17 Apr 2023 (actual)
- Primary completion
- 28 Feb 2025 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 16 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized double-blind placebo-controlled phase 3 clinical trial to further validate the effectiveness and safety of Shugan Jieyu Capsules in treating generalized anxiety disorder.
Detailed description
This trial was a multi-center, randomized, double-blind, two-stage clinical trial in patients with generalized anxiety disorder (TCM differentiated as liver Qi stagnation and spleen deficiency syndrome), consisting of a exploratory study(stage 1) and a confirmatory study(stage 2).
In stage 1, 120 subjects were enrolled and randomly assigned to high-dose group, low-dose group and placebo group at a ratio of 1:1:1.
In stage 2, 495 subjects were randomly assigned to the experimental and placebo groups at a ratio of 1:1.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: Shugan Jieyu Capsules | Experimental | Drug: Shugan Jieyu CapsulesParticipants received Shugan Jieyu Capsules 4 capsules,BID,once in the morning and once in the evening, at an interval of more than 8 hours, for up tp 12 weeks. |
| Experimental: Shugan Jieyu Capsules Placepo | Placebo comparator | Drug: Shugan Jieyu Capsules PlaceboParticipants received Shugan Jieyu Capsules Placebo 4 capsules,BID,once in the morning and once in the evening, at an interval of more than 8 hours, for up tp 12 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Primary diagnosis of generalized anxiety disorder (GAD) as per Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) as confirmed by the MINI at Screening, The duration of illness must be ≥ 6 months；
- Age 18-65 years old；
- Hamilton Anxiety Rating Scale (HAM-A) Total Score of ≥ 14 at both Screening and Baseline，Anxious Mood (item 1) score ≥2；
- Clinical Global Impression of Severity Scale (CGI-S) score of ≥ 3 at both Screening and Baseline
- The TCM syndrome is liver Qi stagnation and spleen deficiency syndrome.
Key exclusion criteria (4 listed)
- Diagnosed with a psychiatric disorder other than GAD that meets DSM-5 criteria within 6 months prior to screening；
- Alcohol or drug abuse or dependence in the 6 months prior to screening, or urine positive for multiple drugs combined at screening
- Hamilton Depression Rating Scale (HAMD-17) Total Score of > 17 at Screening or Baseline，or Depressive Mood (item 1) score ≥2；
- Patients with Severe Insomnia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Shugan Jieyu CapsulesOral, 4 Capsules, BID | Drug | Experimental: Shugan Jieyu Capsules |
| Shugan Jieyu Capsules PlaceboDrug: Shugan Jieyu Capsules Placebo, Oral，4 capsules，BID Drug: Placebo, Oral, 1 capsule, BID | Drug | Experimental: Shugan Jieyu Capsules Placepo |
Primary outcome
Change From Baseline in the HAM-A Total Score at Week 12
Time frame: Change from Baseline to Week 12
The Hamilton Anxiety Rating Scale (HAM-A) is a clinician-administered scale which consists of 14 items, each rated on a five point scale ranging from 0 (not present) to 4 (very severe). The highest possible score is 56, which represents the most severe form of anxiety; the lowest possible score is 0, which represents an absence of anxiety.
9 secondary outcomes
Change From Baseline in the HAM-A Total Score at Week 2, 4, and 8
Time frame: Change from Baseline to Week 2, 4, and 8
The Proportion of Subjects with HAM-A Total Score Reduction Rate ≥50% at week 2, 4, 8 and 12;
Time frame: Change from Baseline to Week 2, 4, 8 and 12
The Proportion of Subjects with HAM-A Total Score ≤7 at week 2, 4, 8 and 12
Time frame: Change from Baseline to Week 2, 4, 8 and 12
Change From Baseline in the HAM-A Mental Anxiety Score at Week 2, 4, 8 and 12
Time frame: Change from Baseline to Week 2, 4, 8 and 12
Change From Baseline in the HAM-A Somatic Anxiety Score at Week 2, 4, 8 and 12
Time frame: Change from Baseline to Week 2, 4, 8 and 12
Change From Baseline in the The World Health Organization Quality of Life (WHOQOL)-BREF at Week 2, 4, 8 and 12
Time frame: Change from Baseline to Week 2, 4, 8 and 12
Change From Baseline in the Clinical Global Impression of Severity Scale (CGI-S) at Week 2, 4, 8 and 12
Time frame: Change from Baseline to Week 2, 4, 8 and 12
Change From Baseline in the Clinical Global Impression of Improvement Scale (CGI-I) at Week 2, 4, 8 and 12
Time frame: Change from Baseline to Week 2, 4, 8 and 12
Change From Baseline in the Traditional Chinese Medicine Syndrome Score Scale at Week 2, 4, 8 and 12
Time frame: Change from Baseline to Week 2, 4, 8 and 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gang Wang, MD principal investigator
Beijing Anding Hospital Affiliated to Capital Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Shugan Jieyu Capsules in people with Generalized Anxiety Disorder, run by Sichuan Jishengtang Pharmaceutical Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ling Song (028-81258178, 022516@cnkh.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in the HAM-A Total Score at Week 12 (time frame: Change from Baseline to Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2024.