Mild Depressive Disorder Comorbid With Anxiety DisorderNCT07295444
A Clinical Study Evaluating the Efficacy and Safety of CreNeuroS CNS Herbal Nutrition Capsules for Participants With Mild Depressive Disorder Comorbid With Anxiety Disorder
A study testing A Clinical Study Evaluating the Efficacy and Safety of CreNeuroS CNS Herbal Nutrition Capsules for Participants With Mild Depressive Disorder Comorbid With Anxiety Disorder in people with Mild Depressive Disorder Comorbid With Anxiety Disorder, run by Second Affiliated Hospital of Nanchang University at 1 site in China.
Trial summary
The incidence of Mild Depressive Disorder Comorbid With Anxiety Disorder is dramatically increasing. dietary supplements may show better efficiency and less side effect.Here investigators intend to assess Efficacy and Safety of CreNeuroS CNS Herbal Nutrition Capsules for Participants With Mild Depressive Disorder… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Mild Depressive Disorder Comorbid With Anxiety Disorder
- What is being tested?
- A Clinical Study Evaluating the Efficacy and Safety of CreNeuroS CNS Herbal Nutrition Capsules for Participants With Mild Depressive Disorder Comorbid With Anxiety Disorder
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 26 Nov 2025to 12 Jan 2026
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
None listed.
Who cannot join
- 1. History of epilepsy, schizophrenia, bipolar and related disorders, intellectual disability, cognitive impairment, or any other neurological or psychiatric disorder that the investigator believes could affect the subject's safety or interfere with study assessments; 2. History of severe cardiovascular diseases meeting any of the following criteria:
- Heart failure (New York Heart Association functional class ≥ III);
- Unstable angina within the past 6 months;
- Any arrhythmia requiring treatment;
- QTc interval prolongation considered clinically significant by the investigator (reference range: men > 450 ms, women > 470 ms) (Note: QTc interval must be calculated according to Fridericia's formula);
- Acute myocardial infarction or interventional procedure within the past month. 3. History of severe gastrointestinal diseases, such as active ulcers or gastrointestinal bleeding; 4. History of severe respiratory diseases, such as chronic obstructive pulmonary disease, cor pulmonale, pulmonary interstitial fibrosis, etc.; 5. Hypertension that is not well controlled by medication: systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg during the screening period. If the first measurement exceeds the limit, it can be repeated after at least 5 minutes on the same day. If three measurements still do not meet the criteria, the subject is ineligible; 6. Clinically diagnosed cerebrovascular accident or intracranial hemorrhage within 6 months; 7. History of moderate to severe sleep apnea, circadian rhythm sleep disorders, narcolepsy, restless legs syndrome, or sleep disorders secondary to other diseases; 8. History of complex sleep behaviors, such as previous episodes of driving, eating, or making phone calls during sleep; 9. Anxiety and/or depressive disorders, or insomnia requiring drug or other interventions during the trial; 10. Exclusion during screening if any of the following abnormalities are present:
- 1) Platelets (PLT) < 100 × 10^9/L, or hemoglobin (Hgb) < 90 g/L; 2) Liver function: AST or ALT > 3 × ULN, TBIL > 2 × ULN; 3) Renal function: serum creatinine > 2 × ULN. 11. History of severe allergic reactions (e.g., anaphylactic shock, laryngeal edema, severe bronchospasm); 12. High risk of suicide: suicide attempt within 1 year prior to screening; suicidal or self-harm behavior during screening; HAMD-17 item 3 (suicide) score ≥ 3; 13. History of abuse or addiction to relevant psychiatric medications; 14. Pregnant or breastfeeding women; 15. Participation in another drug clinical trial within 1 month prior to screening; 16. Any disease or condition that the investigator believes makes the subject unsuitable for participation in the clinical trial.
Trial locations and contacts
1 site in 1 country.
China1 site
Second affiliated hospital of nanchang university
Nanchang, Jiangxi, 330006
About this study
The incidence of Mild Depressive Disorder Comorbid With Anxiety Disorder is dramatically increasing. dietary supplements may show better efficiency and less side effect.Here investigators intend to assess Efficacy and Safety of CreNeuroS CNS Herbal Nutrition Capsules for Participants With Mild Depressive Disorder Comorbid With Anxiety Disorder.
Read the detailed description
This study is a single-center, single-arm, open-label, self-controlled clinical trial evaluating the efficacy and safety of CreNeuroS CNS Herbal Nutrition Capsules in improving mild depressive disorder comorbid with anxiety disorder. The study plans to enroll a total of 30 participants, aged 18-65 years. Eligible participants will be screened and enrolled, stratified by age at 45 years. All participants will take the CreNeuroS CNS Herbal Nutrition Capsules twice daily, morning and evening, two capsules each time, continuously for 42 days, during which efficacy and safety will be assessed.
- Being tested
- A Clinical Study Evaluating the Efficacy and Safety of CreNeuroS CNS Herbal Nutrition Capsules for Participants With Mild Depressive Disorder Comorbid With Anxiety Disorder
- Keywords
- Depressive Anxiety herbal capsules efficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A Clinical Study Evaluating the Efficacy and Safety of CreNeuroS CNS Herbal Nutrition Capsules for Participants With Mild Depressive Disorder Comorbid With Anxiety DisorderDietary supplement
A Clinical Study Evaluating the Efficacy and Safety of CreNeuroS CNS Herbal Nutrition Capsules for Participants With Mild Depressive Disorder Comorbid With Anxiety Disorder
| Study group | Role | What they receive |
|---|---|---|
| Participants with Mild Depressive Disorder Comorbid With Anxiety Disorder | Experimental | Mild Depressive Disorder Comorbid With Anxiety Disorder Receives: Dietary Supplement: A Clinical Study Evaluating the Efficacy and Safety of CreNeuroS CNS Herbal Nutrition Capsules for Participants With Mild Depressive Disorder Comorbid With Anxiety Disorder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change From Baseline in Hamilton Depression Rating Scale-17 Scores of All Participants at Week 6 of Treatment
The HAMD-17 scale score reflects the depressive status of subjects, consisting of 17 items. Most items adopt a 5-point scoring system ranging from 0 to 4.Scoring criteria for each grade: (0) None; (1) Mild; (2) Moderate; (3) Severe; (4) Very severe.A small number of items use a 3-point scoring system from 0 to 2, with grading standards: (0) None; (1) Mild to moderate; (2) Severe.The total score ranges from 0 to 52, calculated by summing the scores of all items. A higher total score indicates a more severe depressive state.
Measured: baseline and 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2025
- Study start26 Nov 2025
- Primary completion12 Jan 2026
- Study completion12 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Mild Depressive Disorder Comorbid With Anxiety DisorderStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital of Nanchang UniversityThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07295444
- Sponsor's protocol ID
- KRD-NX-KN-001
- Status last verified
- Oct 2025
- First submitted
- 7 Dec 2025
- Last updated
- 27 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- 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 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study Evaluating the Efficacy and Safety of CreNeuroS CNS Herbal Nutrition Capsules for Participants With Mild Depressive Disorder Comorbid With Anxiety Disorder
- ClinicalTrials.gov ID
- NCT07295444
- Acronym / sponsor ID
- KRD-NX-KN-001
- Keywords
- Depressive Anxiety herbal capsules efficiency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Second Affiliated Hospital of Nanchang UniversityUniversity, hospital or other
- Study start
- 26 Nov 2025 (actual)
- Primary completion
- 12 Jan 2026 (actual)
- Study completion
- 12 Jan 2026 (actual)
- First posted
- 19 Dec 2025 (actual)
- Results
- Posted 27 Oct 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The incidence of Mild Depressive Disorder Comorbid With Anxiety Disorder is dramatically increasing. dietary supplements may show better efficiency and less side effect.Here investigators intend to assess Efficacy and Safety of CreNeuroS CNS Herbal Nutrition Capsules for Participants With Mild Depressive Disorder Comorbid With Anxiety Disorder.
Detailed description
This study is a single-center, single-arm, open-label, self-controlled clinical trial evaluating the efficacy and safety of CreNeuroS CNS Herbal Nutrition Capsules in improving mild depressive disorder comorbid with anxiety disorder. The study plans to enroll a total of 30 participants, aged 18-65 years. Eligible participants will be screened and enrolled, stratified by age at 45 years. All participants will take the CreNeuroS CNS Herbal Nutrition Capsules twice daily, morning and evening, two capsules each time, continuously for 42 days, during which efficacy and safety will be assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with Mild Depressive Disorder Comorbid With Anxiety Disorder | Experimental | Dietary Supplement: A Clinical Study Evaluating the Efficacy and Safety of CreNeuroS CNS Herbal Nutrition Capsules for Participants With Mild Depressive Disorder Comorbid With Anxiety DisorderMild Depressive Disorder Comorbid With Anxiety Disorder |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (7 listed)
- 1. History of epilepsy, schizophrenia, bipolar and related disorders, intellectual disability, cognitive impairment, or any other neurological or psychiatric disorder that the investigator believes could affect the subject's safety or interfere with study assessments; 2. History of severe cardiovascular diseases meeting any of the following criteria:
- Heart failure (New York Heart Association functional class ≥ III);
- Unstable angina within the past 6 months;
- Any arrhythmia requiring treatment;
- QTc interval prolongation considered clinically significant by the investigator (reference range: men > 450 ms, women > 470 ms) (Note: QTc interval must be calculated according to Fridericia's formula);
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 |
|---|---|---|
| A Clinical Study Evaluating the Efficacy and Safety of CreNeuroS CNS Herbal Nutrition Capsules for Participants With Mild Depressive Disorder Comorbid With Anxiety DisorderA Clinical Study Evaluating the Efficacy and Safety of CreNeuroS CNS Herbal Nutrition Capsules for Participants With Mild Depressive Disorder Comorbid With Anxiety Disorder | Dietary supplement | Participants with Mild Depressive Disorder Comorbid With Anxiety Disorder |
Primary outcome
Mean Change From Baseline in Hamilton Depression Rating Scale-17 Scores of All Participants at Week 6 of Treatment
Time frame: baseline and 6 weeks
The HAMD-17 scale score reflects the depressive status of subjects, consisting of 17 items. Most items adopt a 5-point scoring system ranging from 0 to 4.Scoring criteria for each grade: (0) None; (1) Mild; (2) Moderate; (3) Severe; (4) Very severe.A small number of items use a 3-point scoring system from 0 to 2, with grading standards: (0) None; (1) Mild to moderate; (2) Severe.The total score ranges from 0 to 52, calculated by summing the scores of all items. A higher total score indicates a more severe depressive state.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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 A Clinical Study Evaluating the Efficacy and Safety of CreNeuroS CNS Herbal Nutrition Capsules for Participants With Mild Depressive Disorder Comorbid With Anxiety Disorder in people with Mild Depressive Disorder Comorbid With Anxiety Disorder, run by Second Affiliated Hospital of Nanchang University 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 0 inclusion and 7 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 27 Oct 2026. 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?
Yes. Results are posted in the registry (first posted 27 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Mean Change From Baseline in Hamilton Depression Rating Scale-17 Scores of All Participants at Week 6 of Treatment (time frame: baseline and 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 27 Oct 2026.