An Early Phase 1 interventional study of Volatile Oil of Cang-Ai and Bergamot essential oils in Depressive Disorder and Mental Disorder in Adolescence, sponsored by Jieqiong Cui. Status unknown. Open to participants aged 6 Years to 28 Years. Per ClinicalTrials.gov, last updated 2022-10-20.
Sponsored by Jieqiong Cui · Early Phase 1, Interventional, and Treatment
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.
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.
4,846 studies on the registry are indexed under Depressive Disorder; 509 are open to participants now.
This study's planned enrollment of 60 is below the median of 80 across 3,997 interventional studies indexed under Depressive Disorder.
Browse Depressive Disorder studies →This is the only study on the registry with Jieqiong Cui as lead sponsor.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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.
Exclusion Criteria:
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
The test group inhaled the volatile oil of Cang-Ai at a concentration of 1% by inhalation once a day for 30 minutes
Drug: Volatile Oil of Cang-Ai
The control group inhaled the bergamot essential oils at a concentration of 1% by inhalation once a day for 30 minutes
Drug: Bergamot essential oils
The test group will be given Volatile oil of Cang-Ai (hereafter referred to as CAVO) for inhalation
Also known as: CAVO
The control group will be given Bergamot essential oils for inhalation.
Also known as: Citrus bergamia
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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: At the end of Cycle 2 (each cycle is 14 days)
Change from blood pressure
Patients' blood pressure will be measured by a blood pressure monitor
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: At the end of Cycle 2 (each cycle is 14 days)
No study locations are listed for this record.
Plan to share: 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
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: After Dec 2022
Access criteria: Sharing with researcher for Meta-analysis
No publications or documents are linked to this record.
Start is estimated for Nov 2022; primary completion for Dec 2022, 1 month later.
Of 52 non-industry phase 1 interventional studies under Depressive Disorder, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 45. This study's planned 1 month is below that.
Counting every sponsor, half of 109 studies reached it within 9 months; a quarter within 3 and three quarters within 27.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.
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