A Clinical Study on the Effects of Inhalation of Volatile Oil of Cang-Ai Via the Nose on Patients With Depression

Depressive Disorder Clinical Trial

Official title:

A Clinical Study on the Effects of Inhalation of Volatile Oil of Cang-Ai Via the Nose on Patients With Depression

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05251779
• Other study ID #: YunnanUCM
• Status: Not yet recruiting
• Phase: Early Phase 1
• Start date: November 1, 2022
• Est. completion date: December 1, 2022

Study information

• Verified date: October 2022
• Source: Yunnan University of Chinese Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 1, 2022
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 28 Years

Eligibility

Inclusion Criteria:

• 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 ?All subjects volunteered to participate and signed an informed consent form after approval by the hospital's ethics committee

Exclusion Criteria:

• History of schizophrenia, alcohol and drug dependence strictly excluded ?Depression 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 ?Pregnant and breastfeeding women with a history of manic or hypomanic episodes ?Family history of monophasic or bipolar disorder

Related Conditions & MeSH terms

• Depressive Disorder
• Disease
• Mental Disorder in Adolescence
• Mental Disorders
• Respiratory Aspiration

Intervention

Drug:
• Volatile Oil of Cang-Ai
The test group will be given Volatile oil of Cang-Ai (hereafter referred to as CAVO) for inhalation
• Bergamot essential oils
The control group will be given Bergamot essential oils for inhalation.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Jieqiong Cui

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	At the end of Cycle 1 (each cycle is 14 days)
Primary	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)	At the end of Cycle 2 (each cycle is 14 days)
Primary	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)	At the end of Cycle 1 (each cycle is 14 days)
Primary	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)	At the end of Cycle 2 (each cycle is 14 days)
Secondary	Change from blood pressure	Patients' blood pressure will be measured by a blood pressure monitor	At the end of Cycle 1 (each cycle is 14 days)
Secondary	Change from blood pressure at 28 days	Patients' blood pressure will be measured by a blood pressure monitor	At the end of Cycle 2 (each cycle is 14 days)
Secondary	Change from heart rate	Patients' heart rate will be measured by a heart rate monitor	At the end of Cycle 1 (each cycle is 14 days)
Secondary	Change from heart rate at 28 days	Patients' heart rate will be measured by a heart rate monitor	At the end of Cycle 2 (each cycle is 14 days)