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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Depressive Disorder; Mental Disorder in Adolescence
• Intervention / Treatment: Drug: Volatile Oil of Cang-Ai; Drug: Bergamot essential oils

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Early Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 28 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 ⑤All 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 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cang-Ai Group; 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 test group will be given Volatile oil of Cang-Ai (hereafter referred to as CAVO) for inhalation; Other Names: CAVO
Active Comparator: Bergamot group; 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 control group will be given Bergamot essential oils for inhalation.; Other Names: Citrus bergamia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
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)

Collaborators and Investigators

• Sponsor: Jieqiong Cui

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2022
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: January 24, 2022
• First Submitted That Met QC Criteria: February 22, 2022
• First Posted (Actual): February 23, 2022

Study Record Updates

• Last Update Posted (Actual): October 20, 2022
• Last Update Submitted That Met QC Criteria: October 19, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Aromatic Herbs; Volatile oils; Inhalation via the nose
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Mood Disorders; Respiration Disorders; Depressive Disorder; Disease; Respiratory Aspiration; Mental Disorders
• Other Study ID Numbers: YunnanUCM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: 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
• IPD Sharing Time Frame: After Dec 2022
• IPD Sharing Access Criteria: Sharing with researcher for Meta-analysis
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No