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

NCT05251779 | Unknown Early Phase 1

• 1 other identifier: YunnanUCM
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Depressive Disorder; Mental Disorder in Adolescence

Keywords

Aromatic Herbs; Volatile oils; Inhalation via the nose

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• Change from blood pressure

  At the end of Cycle 1 (each cycle is 14 days)

• Change from blood pressure at 28 days

  At the end of Cycle 2 (each cycle is 14 days)

• Change from heart rate

  At the end of Cycle 1 (each cycle is 14 days)

• Change from heart rate at 28 days

  At the end of Cycle 2 (each cycle is 14 days)

Study Arms (2)

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

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

Drug: Bergamot essential oils

Interventions

Volatile Oil of Cang-Ai DRUG

The test group will be given Volatile oil of Cang-Ai (hereafter referred to as CAVO) for inhalation

Also known as: CAVO

Cang-Ai Group

Bergamot essential oils DRUG

The control group will be given Bergamot essential oils for inhalation.

Also known as: Citrus bergamia

Bergamot group

Eligibility Criteria

• Age: 6 Years - 28 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jieqiong Cui: lead

MeSH Terms

Conditions

Depressive Disorder

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Doctoral students

Study Record Dates

• First Submitted: January 24, 2022
• First Posted: February 23, 2022
• Study Start: November 1, 2022
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: October 20, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: After Dec 2022
• Access Criteria: Sharing with researcher for Meta-analysis