Depressive DisorderEarly Phase 1NCT05251779
A Clinical Study on the Effects of Inhalation of Volatile Oil of Cang-Ai Via the Nose on Patients With Depression
A Early Phase 1 study testing Volatile Oil of Cang-Ai and Bergamot essential oils in people with Depressive Disorder and Mental Disorder in Adolescence, run by Jieqiong Cui.
Trial summary
In this study, 60 depressed patients who meet the criteria will randomly be divided into a test group and a control group, with 30 patients in each group. The test group will be given Volatile oil of Cang-Ai (hereafter referred to as CAVO) for inhalation and the control group will be given Bergamot for inhalation. Read more about this study
- Who is it for?
- Ages 6 to 28 years
- Conditions the study is for
- Depressive Disorder, Mental Disorder in Adolescence
- What is being tested?
- Volatile Oil of Cang-Ai and Bergamot essential oils
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2022to 1 Dec 2022
- Phase
- Early Phase 1
- 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 6 to 28 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Meeting the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) diagnostic criteria for depressive episodes.
- Beck Depression Scale >10; 24-item Hamilton Depression Scale (HAMD) score >20
- Healthy sense of smell, no allergic diseases, respiratory diseases, age 16-40 years, male or female.
- No use of antidepressants and other psychiatric drugs or physiotherapy such as electroconvulsive shock or transcranial magnetic stimulation (TMS) for at least 1 week prior to the intervention ⑤All subjects volunteered to participate and signed an informed consent form after approval by the hospital's ethics committee
Who cannot join
- History of schizophrenia, alcohol and drug dependence strictly excluded ②Depression with a history of organic brain disease and endocrine disorders or secondary to other psychiatric disorders
- Score >3 on the Hamilton Depression Inventory for Suicide ④Pregnant and breastfeeding women with a history of manic or hypomanic episodes ⑤Family history of monophasic or bipolar disorder
About this study
In this study, 60 depressed patients who meet the criteria will randomly be divided into a test group and a control group, with 30 patients in each group. The test group will be given Volatile oil of Cang-Ai (hereafter referred to as CAVO) for inhalation and the control group will be given Bergamot for inhalation. The observation indicators are that after one and two sessions of the intervention, the patients' blood pressure, heart rate, depression scale scores, and changes in functional near-infrared spectroscopy(fNIRS). This randomized controlled trial will be used to look at the clinical efficacy of CAVO in patients with depression.
Read the detailed description
Depression is a common psychiatric disorder characterised by persistent depressed mood, loss of interest and feelings of helplessness. Depression has the highest burden of illness of any mental illness and is the leading cause of disability. Currently, depression is usually treated with antidepressants as the first line of treatment, but because the pathophysiological mechanisms of depression are still unclear, the mechanisms of antidepressant treatment are unknown, and there is no objective way to predict efficacy, depression often requires multiple "trial and error treatments" before an effective treatment plan can be determined. Chemically synthesised drugs are widely used to treat depression, but side effects have become a bottleneck to their long-term use. As a result, natural products from medicinal plants, such as Essential oils or Volatile oils, have become research targets for the development of new drugs. Volatile oil of Cang-Ai is a component extracted from aromatic Chinese herbs such as Atractlodis Rhizoma, Herba Agastaches, Flos Caryophylli, which is commonly used clinically in the treatment of mood disorders. This study will use a randomised controlled study method. 60 patients with depression who attended the First Affiliated Hospital of Yunnan University of Traditional Chinese Medicine from March 2022 to September 2022 will be recruited.
They will be randomly divided into a trial group and a control group, 30 patients in each group. The test group will be given Volatile oil of Cang-Ai for inhalation and the control group will be given Bergamot for inhalation. Ultimately, a number of indicators will be tested to assess the clinical efficacy of the volatile oil of Cang-Ai.
- Being tested
- Volatile Oil of Cang-Ai, Bergamot essential oils
- Keywords
- Aromatic Herbs, Volatile oils, Inhalation via the nose
- Medical subject headings
- Depressive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Volatile Oil of Cang-AiDrug
Also called CAVO
The test group will be given Volatile oil of Cang-Ai (hereafter referred to as CAVO) for inhalation
Bergamot essential oilsDrug
Also called Citrus bergamia
The control group will be given Bergamot essential oils for inhalation.
| Study group | Role | What they receive |
|---|---|---|
| Cang-Ai Group | Experimental | The test group inhaled the volatile oil of Cang-Ai at a concentration of 1% by inhalation once a day for 30 minutes Receives: Drug: Volatile Oil of Cang-Ai |
| Bergamot group | Active comparator | The control group inhaled the bergamot essential oils at a concentration of 1% by inhalation once a day for 30 minutes Receives: Drug: Bergamot essential oils |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from functional near-infrared spectroscopy（fNIRS) at 28 days
Functional near-infrared spectroscopy to measure changes in the relative concentrations of Oxy-Hb and Deoxy-Hb in the cerebral cortex (prefrontal and temporal lobes)
Measured: At the end of Cycle 1 (each cycle is 14 days)
Change from functional near-infrared spectroscopy（fNIRS) at 28 days
Functional near-infrared spectroscopy to measure changes in the relative concentrations of Oxy-Hb and Deoxy-Hb in the cerebral cortex (prefrontal and temporal lobes)
Measured: At the end of Cycle 2 (each cycle is 14 days)
24-item Hamilton Depression Inventory scores
The following severity ranges for the HAMD: no depression (0-7); mild depression (8-16); moderate depression (17-23); and severe depression (≥24)
Measured: At the end of Cycle 1 (each cycle is 14 days)
24-item Hamilton Depression Inventory scores
The following severity ranges for the HAMD: no depression (0-7); mild depression (8-16); moderate depression (17-23); and severe depression (≥24)
Measured: At the end of Cycle 2 (each cycle is 14 days)
Secondary outcomes (4)
Change from blood pressure
Patients' blood pressure will be measured by a blood pressure monitor
Measured: At the end of Cycle 1 (each cycle is 14 days)
Change from blood pressure at 28 days
Patients' blood pressure will be measured by a blood pressure monitor
Measured: At the end of Cycle 2 (each cycle is 14 days)
Change from heart rate
Patients' heart rate will be measured by a heart rate monitor
Measured: At the end of Cycle 1 (each cycle is 14 days)
Change from heart rate at 28 days
Patients' heart rate will be measured by a heart rate monitor
Measured: At the end of Cycle 2 (each cycle is 14 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2022
- Study start1 Nov 2022 (estimated)
- Primary completion1 Dec 2022 (estimated)
- Study completion1 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jieqiong Cui
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jieqiong Cui, Yunnan University of Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05251779
- Sponsor's protocol ID
- YunnanUCM
- Status last verified
- Oct 2022
- First submitted
- 24 Jan 2022
- Last updated
- 20 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The original data from each eligible study. including de-identified demographic information for each participant such as age, sex, nature of their health condition, as well as information about treatments or tests received and outcomes observed
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study on the Effects of Inhalation of Volatile Oil of Cang-Ai Via the Nose on Patients With Depression
- ClinicalTrials.gov ID
- NCT05251779
- Acronym / sponsor ID
- YunnanUCM
- Keywords
- Aromatic Herbs, Volatile oils, Inhalation via the nose
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Jieqiong CuiUniversity, hospital or other
- Study start
- 1 Nov 2022 (estimated)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 23 Feb 2022 (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.
In this study, 60 depressed patients who meet the criteria will randomly be divided into a test group and a control group, with 30 patients in each group. The test group will be given Volatile oil of Cang-Ai (hereafter referred to as CAVO) for inhalation and the control group will be given Bergamot for inhalation. The observation indicators are that after one and two sessions of the intervention, the patients' blood pressure, heart rate, depression scale scores, and changes in functional near-infrared spectroscopy(fNIRS). This randomized controlled trial will be used to look at the clinical efficacy of CAVO in patients with depression.
Detailed description
Depression is a common psychiatric disorder characterised by persistent depressed mood, loss of interest and feelings of helplessness. Depression has the highest burden of illness of any mental illness and is the leading cause of disability. Currently, depression is usually treated with antidepressants as the first line of treatment, but because the pathophysiological mechanisms of depression are still unclear, the mechanisms of antidepressant treatment are unknown, and there is no objective way to predict efficacy, depression often requires multiple "trial and error treatments" before an effective treatment plan can be determined. Chemically synthesised drugs are widely used to treat depression, but side effects have become a bottleneck to their long-term use. As a result, natural products from medicinal plants, such as Essential oils or Volatile oils, have become research targets for the development of new drugs. Volatile oil of Cang-Ai is a component extracted from aromatic Chinese herbs such as Atractlodis Rhizoma, Herba Agastaches, Flos Caryophylli, which is commonly used clinically in the treatment of mood disorders. This study will use a randomised controlled study method. 60 patients with depression who attended the First Affiliated Hospital of Yunnan University of Traditional Chinese Medicine from March 2022 to September 2022 will be recruited.
They will be randomly divided into a trial group and a control group, 30 patients in each group. The test group will be given Volatile oil of Cang-Ai for inhalation and the control group will be given Bergamot for inhalation. Ultimately, a number of indicators will be tested to assess the clinical efficacy of the volatile oil of Cang-Ai.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cang-Ai Group | Experimental | Drug: Volatile Oil of Cang-AiThe test group inhaled the volatile oil of Cang-Ai at a concentration of 1% by inhalation once a day for 30 minutes |
| Bergamot group | Active comparator | Drug: Bergamot essential oilsThe control group inhaled the bergamot essential oils at a concentration of 1% by inhalation once a day for 30 minutes |
Who may qualify
- Ages
- 6 to 28 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Meeting the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) diagnostic criteria for depressive episodes.
Key exclusion criteria (2 listed)
- History of schizophrenia, alcohol and drug dependence strictly excluded ②Depression with a history of organic brain disease and endocrine disorders or secondary to other psychiatric disorders
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 |
|---|---|---|
| Volatile Oil of Cang-AiAlso: CAVOThe test group will be given Volatile oil of Cang-Ai (hereafter referred to as CAVO) for inhalation | Drug | Cang-Ai Group |
| Bergamot essential oilsAlso: Citrus bergamiaThe control group will be given Bergamot essential oils for inhalation. | Drug | Bergamot group |
Primary outcome
Change from functional near-infrared spectroscopy（fNIRS) at 28 days
Time frame: At the end of Cycle 1 (each cycle is 14 days)
Functional near-infrared spectroscopy to measure changes in the relative concentrations of Oxy-Hb and Deoxy-Hb in the cerebral cortex (prefrontal and temporal lobes)
Change from functional near-infrared spectroscopy（fNIRS) at 28 days
Time frame: At the end of Cycle 2 (each cycle is 14 days)
Functional near-infrared spectroscopy to measure changes in the relative concentrations of Oxy-Hb and Deoxy-Hb in the cerebral cortex (prefrontal and temporal lobes)
24-item Hamilton Depression Inventory scores
Time frame: At the end of Cycle 1 (each cycle is 14 days)
The following severity ranges for the HAMD: no depression (0-7); mild depression (8-16); moderate depression (17-23); and severe depression (≥24)
24-item Hamilton Depression Inventory scores
Time frame: At the end of Cycle 2 (each cycle is 14 days)
The following severity ranges for the HAMD: no depression (0-7); mild depression (8-16); moderate depression (17-23); and severe depression (≥24)
4 secondary outcomes
Change from blood pressure
Time frame: At the end of Cycle 1 (each cycle is 14 days)
Change from blood pressure at 28 days
Time frame: At the end of Cycle 2 (each cycle is 14 days)
Change from heart rate
Time frame: At the end of Cycle 1 (each cycle is 14 days)
Change from heart rate at 28 days
Time frame: At the end of Cycle 2 (each cycle is 14 days)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2022.
- Individual participant dataSharing planned: Yes. The original data from each eligible study. including de-identified demographic information for each participant such as age, sex, nature of their health condition, as well as information about treatments or tests received and outcomes observed
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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.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Volatile Oil of Cang-Ai and Bergamot essential oils in people with Depressive Disorder and Mental Disorder in Adolescence, run by Jieqiong Cui.
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 2 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: status not confirmed, as of the sponsor's last update on 20 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Change from functional near-infrared spectroscopy（fNIRS) at 28 days (time frame: At the end of Cycle 1 (each cycle is 14 days)). The study lists 4 primary outcomes in all. 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 20 Oct 2022.