## Protocol Section
### Identification Module
**NCT ID:** NCT05251779

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

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

#### Organization Study ID Info
**ID:** YunnanUCM
#### Organization
**Class:** OTHER
**Full Name:** Yunnan University of Chinese Medicine
### Status Module
#### Completion Date
**Date:** 2022-12-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2022-10-20

**Type:** ACTUAL

**Last Update Submit Date:** 2022-10-19

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2022-12-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2022-11-01

**Type:** ESTIMATED

**Status Verified Date:** 2022-10

#### Study First Post Date
**Date:** 2022-02-23
**Type:** ACTUAL
**Study First Submit Date:** 2022-01-24
**Study First Submit QC Date:** 2022-02-22
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Jieqiong Cui

#### Responsible Party

**Investigator Affiliation:** Yunnan University of Chinese Medicine

**Investigator Full Name:** Jieqiong Cui

**Investigator Title:** Doctoral students

**Type:** SPONSOR_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

**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.

### Conditions Module

**Conditions:**

- Depressive Disorder

- Mental Disorder in Adolescence

**Keywords:**

- Aromatic Herbs

- Volatile oils

- Inhalation via the nose

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** TRIPLE

**Who Masked:**

- PARTICIPANT

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 60

**Type:** ESTIMATED

**Phases:**

- EARLY_PHASE1

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** The test group inhaled the volatile oil of Cang-Ai at a concentration of 1% by inhalation once a day for 30 minutes

**Intervention Names:**

- Drug: Volatile Oil of Cang-Ai

**Label:** Cang-Ai Group

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** The control group inhaled the bergamot essential oils at a concentration of 1% by inhalation once a day for 30 minutes

**Intervention Names:**

- Drug: Bergamot essential oils

**Label:** Bergamot group

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Cang-Ai Group

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

**Name:** Volatile Oil of Cang-Ai

**Other Names:**

- CAVO

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Bergamot group

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

**Name:** Bergamot essential oils

**Other Names:**

- Citrus bergamia

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** 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)

**Measure:** Change from functional near-infrared spectroscopy（fNIRS) at 28 days

**Time Frame:** At the end of Cycle 1 (each cycle is 14 days)

**Description:** 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)

**Measure:** Change from functional near-infrared spectroscopy（fNIRS) at 28 days

**Time Frame:** At the end of Cycle 2 (each cycle is 14 days)

**Description:** The following severity ranges for the HAMD: no depression (0-7); mild depression (8-16); moderate depression (17-23); and severe depression (≥24)

**Measure:** 24-item Hamilton Depression Inventory scores

**Time Frame:** At the end of Cycle 1 (each cycle is 14 days)

**Description:** The following severity ranges for the HAMD: no depression (0-7); mild depression (8-16); moderate depression (17-23); and severe depression (≥24)

**Measure:** 24-item Hamilton Depression Inventory scores

**Time Frame:** At the end of Cycle 2 (each cycle is 14 days)

#### Secondary Outcomes

**Description:** Patients' blood pressure will be measured by a blood pressure monitor

**Measure:** Change from blood pressure

**Time Frame:** At the end of Cycle 1 (each cycle is 14 days)

**Description:** Patients' blood pressure will be measured by a blood pressure monitor

**Measure:** Change from blood pressure at 28 days

**Time Frame:** At the end of Cycle 2 (each cycle is 14 days)

**Description:** Patients' heart rate will be measured by a heart rate monitor

**Measure:** Change from heart rate

**Time Frame:** At the end of Cycle 1 (each cycle is 14 days)

**Description:** Patients' heart rate will be measured by a heart rate monitor

**Measure:** Change from heart rate at 28 days

**Time Frame:** At the end of Cycle 2 (each cycle is 14 days)

### Eligibility Module

**Eligibility Criteria:** 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

**Maximum Age:** 28 Years

**Minimum Age:** 6 Years

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

### IPD Sharing Statement Module

**Access Criteria:** Sharing with researcher for Meta-analysis

**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

**Info Types:**

- STUDY_PROTOCOL

- SAP

- ICF

- CSR

**IPD Sharing:** YES

**Time Frame:** After Dec 2022

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000019964

- Term: Mood Disorders

- ID: D000012120

- Term: Respiration Disorders

- ID: D000012140

- Term: Respiratory Tract Diseases

- ID: D000010335

- Term: Pathologic Processes

### Condition Browse Module - Browse Branches

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: All

- Name: All Conditions

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M7058

- Name: Depression

- Relevance: LOW

- As Found: Unknown

- ID: M7061

- Name: Depressive Disorder

- Relevance: HIGH

- As Found: Depressive Disorder

- ID: M27137

- Name: Respiratory Aspiration

- Relevance: HIGH

- As Found: Inhalation

- ID: M4815

- Name: Mental Disorders

- Relevance: HIGH

- As Found: Mental Disorders

- ID: M14473

- Name: Psychotic Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M21835

- Name: Mood Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M14957

- Name: Respiration Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M14977

- Name: Respiratory Tract Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000053120

- Term: Respiratory Aspiration

- ID: D000003866

- Term: Depressive Disorder

- ID: D000001523

- Term: Mental Disorders

### Misc Info Module

- Version Holder: 2024-05-24
