Generalised Anxiety DisorderNCT06725771
A Non-randomized Controlled Trial Was Conducted to Observe the Improvement in the Level of HAMA in Patients With Generalized Anxiety Disorder During the 6-week Period of Oral Treatment With Chaihu Jia Longgu Muli Tang (Bupleurum Plus Dragon Bone and Oyster Shell Decoction) Combined With Sertraline.
A study testing Bupleurum Plus Dragon Bone and Oyster Shell Decoction Combined with Sertraline and Sertraline Hydrochloride Tablets in people with Generalised Anxiety Disorder, run by Lin Xiaoqian at 1 site in China.
Trial summary
The purpose of this study is to clinically observe the efficacy of Bupleurum Plus Dragon Bone and Oyster Shell Decoction in the treatment of Generalized Anxiety Disorder to improve the scores of HAMA Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Generalised Anxiety Disorder
- What is being tested?
- Bupleurum Plus Dragon Bone and Oyster Shell Decoction Combined with Sertraline and Sertraline Hydrochloride Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 205 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2022to 31 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meets the western medical diagnostic criteria for generalized anxiety disorder;
- The TCM diagnosis is Heat-Depressed on Shao-Yang (rè yù shǎo yáng) type;
- Hamilton Anxiety Scale (HAMA) score ≥ 7;
- Age 18-80 years old.
Who cannot join
- Allergy to Chinese Medicine formulas;
- Pregnant or breastfeeding;
- Suicidal ideation and suicide attempt;
- Substance use disorders;
- Severe cardiovascular diseases liver diseases and kidney diseases.
Trial locations and contacts
1 site in 1 country.
China1 site
Jiangsu Province Hospital of TCM Affiliated Hospital of Nanjing University of Chinese Medicine
Nanjing, Jiangsu, 210029
About this study
Official title: Clinical Study on the Treatment of Generalized Anxiety Disorder With Chaihu Jia Longgu Muli Tang (Bupleurum Plus Dragon Bone and Oyster Shell Decoction)
The purpose of this study is to clinically observe the efficacy of Bupleurum Plus Dragon Bone and Oyster Shell Decoction in the treatment of Generalized Anxiety Disorder to improve the scores of HAMA
Read the detailed description
Generalized Anxiety Disorder, not only results in a disturbed psychological condition, but even daily life with coworkers and family will also be disrupted. Chaihu Jia Longgu Muli Tang (Bupleurum Plus Dragon Bone and Oyster Shell Decoction), a compound Chinese herbal medicine found in "Treatise on Cold Damage", has been used for treating mental disorders with symptoms such as chest distress, irritability, being frightened, etc since the China Han dynasty. In this study, we will observe the efficacy of this formula, in order to provide an evidence-based basis for clinical observation and evaluation of Generalized Anxiety Disorder.
- Conditions
- Generalised Anxiety Disorder
- Being tested
- Bupleurum Plus Dragon Bone and Oyster Shell Decoction Combined with Sertraline, Sertraline Hydrochloride Tablets
- Keywords
- Generalized Anxiety Disorder, Chaihu Jia Longgu Muli Tang, Sertraline, Heat-Depressed on Shao-Yang
- 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.
Bupleurum Plus Dragon Bone and Oyster Shell Decoction Combined with SertralineDrug
Bupleurum Plus Dragon Bone and Oyster Shell Decoction and Sertraline are given to patients simultaneously
Sertraline Hydrochloride TabletsDrug
Sertraline are given to patients simultaneously
| Study group | Role | What they receive |
|---|---|---|
| Bupleurum Plus Dragon Bone and Oyster Shell Decoction with sertraline | Experimental | observation group Receives: Drug: Bupleurum Plus Dragon Bone and Oyster Shell Decoction Combined with Sertraline |
| Sertraline | Active comparator | Control group Receives: Drug: Sertraline Hydrochloride Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamilton Anxiety Scale (HAMA)
To evaluate participant's anxiety status
Measured: 0, 2, 4, 6 weeks
Secondary outcomes (1)
Heat-Depressed on Shaoyang scale
To evaluate participant's somatic symptoms, based on Chaihu Jia Longgu Muli Tang treatment
Measured: 0, 2, 4, 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2024
- Study start1 Sep 2022
- Primary completion31 Oct 2024
- Study completion31 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Generalised 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 205 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lin Xiaoqian
- Sponsor type
- University, hospital or other
- Collaborators
- Jiangsu Province Hospital of Traditional Chinese Medicine
- Responsible party
- Sponsor-investigator, Lin Xiaoqian, Jiangsu Province Hospital of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06725771
- Sponsor's protocol ID
- 2024NL-253-02
- Status last verified
- Dec 2024
- First submitted
- 6 Dec 2024
- Last updated
- 10 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 10 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on the Treatment of Generalized Anxiety Disorder With Chaihu Jia Longgu Muli Tang (Bupleurum Plus Dragon Bone and Oyster Shell Decoction)
- ClinicalTrials.gov ID
- NCT06725771
- Acronym / sponsor ID
- 2024NL-253-02
- Conditions
- Generalised Anxiety Disorder
- Keywords
- Generalized Anxiety Disorder, Chaihu Jia Longgu Muli Tang, Sertraline, Heat-Depressed on Shao-Yang
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 205 participants (actual)
- Lead sponsor
- Lin XiaoqianUniversity, hospital or other
- Collaborators
- Jiangsu Province Hospital of Traditional Chinese Medicine
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 31 Oct 2024 (actual)
- Study completion
- 31 Oct 2024 (actual)
- First posted
- 10 Dec 2024 (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.
The purpose of this study is to clinically observe the efficacy of Bupleurum Plus Dragon Bone and Oyster Shell Decoction in the treatment of Generalized Anxiety Disorder to improve the scores of HAMA
Detailed description
Generalized Anxiety Disorder, not only results in a disturbed psychological condition, but even daily life with coworkers and family will also be disrupted. Chaihu Jia Longgu Muli Tang (Bupleurum Plus Dragon Bone and Oyster Shell Decoction), a compound Chinese herbal medicine found in "Treatise on Cold Damage", has been used for treating mental disorders with symptoms such as chest distress, irritability, being frightened, etc since the China Han dynasty. In this study, we will observe the efficacy of this formula, in order to provide an evidence-based basis for clinical observation and evaluation of Generalized Anxiety Disorder.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bupleurum Plus Dragon Bone and Oyster Shell Decoction with sertraline | Experimental | Drug: Bupleurum Plus Dragon Bone and Oyster Shell Decoction Combined with Sertralineobservation group |
| Sertraline | Active comparator | Drug: Sertraline Hydrochloride TabletsControl group |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Meets the western medical diagnostic criteria for generalized anxiety disorder;
- The TCM diagnosis is Heat-Depressed on Shao-Yang (rè yù shǎo yáng) type;
- Hamilton Anxiety Scale (HAMA) score ≥ 7;
- Age 18-80 years old.
Key exclusion criteria (5 listed)
- Allergy to Chinese Medicine formulas;
- Pregnant or breastfeeding;
- Suicidal ideation and suicide attempt;
- Substance use disorders;
- Severe cardiovascular diseases liver diseases and kidney diseases.
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 |
|---|---|---|
| Bupleurum Plus Dragon Bone and Oyster Shell Decoction Combined with SertralineBupleurum Plus Dragon Bone and Oyster Shell Decoction and Sertraline are given to patients simultaneously | Drug | Bupleurum Plus Dragon Bone and Oyster Shell Decoction with sertraline |
| Sertraline Hydrochloride TabletsSertraline are given to patients simultaneously | Drug | Sertraline |
Primary outcome
Hamilton Anxiety Scale (HAMA)
Time frame: 0, 2, 4, 6 weeks
To evaluate participant's anxiety status
1 secondary outcome
Heat-Depressed on Shaoyang scale
Time frame: 0, 2, 4, 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bupleurum Plus Dragon Bone and Oyster Shell Decoction Combined with Sertraline and Sertraline Hydrochloride Tablets in people with Generalised Anxiety Disorder, run by Lin Xiaoqian 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 4 inclusion and 5 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: finished, as of the sponsor's last update on 10 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hamilton Anxiety Scale (HAMA) (time frame: 0, 2, 4, 6 weeks). 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 10 Dec 2024.