## Protocol Section
### Identification Module
**NCT ID:** NCT06429514

**Brief Title:** Study on the Mechanism of Ganoderma Lucidum Spore Powder in the Treatment of Depression

**Official Title:** Based on the Theory of Gut-brain Axis, the Intervention Effect and Related Mechanism of Ganoderma Lucidum Spore Powder on Depressive Symptoms in Patients With Thyroid Cancer Were Investigated

#### Organization Study ID Info
**ID:** IRB-2023-307
#### Organization
**Class:** OTHER
**Full Name:** Zhejiang Cancer Hospital
### Status Module
#### Completion Date
**Date:** 2024-05-03

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-20

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2024-05-03

**Type:** ACTUAL

#### Start Date
**Date:** 2023-03-28

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-15
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module

#### Collaborators

**Class:** INDUSTRY

**Name:** Zhejiang Shouxiangu Pharmaceutical Co,. Ltd.

#### Lead Sponsor

**Class:** OTHER

**Name:** Ling Zhiqiang

#### Responsible Party

**Investigator Affiliation:** Zhejiang Cancer Hospital

**Investigator Full Name:** Ling Zhiqiang

**Investigator Title:** Principal Investigator

**Type:** SPONSOR_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** To clarify the clinical effect of Ganoderma lucidum spore powder intervention on postoperative depressive symptoms of papillary thyroid carcinoma ; to elucidate the antidepressant mechanism of Ganoderma lucidum spore powder.

**Detailed Description:** After being informed of the study and potential risks, all patients who gave written informed consent were enrolled. A total of 300 eligible patients were randomly assigned in a double-blind manner and divided into experimental group and control group at a ratio of 2 : 1. The subjects were given oral test drugs ( Ganoderma lucidum spore powder or placebo ) 4g per day for 90 days from the first day after enrollment.

### Conditions Module

**Conditions:**

- Depression

- Thyroid Cancer

**Keywords:**

- Depression

- Thyroid Cancer

- the gut-brain axis

- ganoderma lucidum

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

**Intervention Model Description:** Patients with depressive symptoms after papillary thyroid carcinoma surgery 300 cases ; there were 200 cases in the experimental group and 100 cases in the control group. From the first day after enrollment, the subjects were given 4 g of the test drug ( Ganoderma lucidum spore powder or placebo ) every day for 90 days.

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 298

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Oral administration of Ganoderma lucidum spore powder 4g per day ( 1 bag at a time, 2 times a day, 2g / bag ) for 90 days

**Intervention Names:**

- Dietary Supplement: Ganoderma lucidum spore powder

**Label:** Ganoderma lucidum spore powder

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Oral ' placebo ' 4g per day ( 1 bag at a time, 2 times a day, 2g / bag ) for 90 days.

**Intervention Names:**

- Other: placebo

**Label:** placebo

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Ganoderma lucidum spore powder

**Description:** One bag at a time, 2 times a day, 2g / bag

**Name:** Ganoderma lucidum spore powder

**Type:** DIETARY_SUPPLEMENT

#### Intervention 2

**Arm Group Labels:**

- placebo

**Description:** One bag at a time, 2 times a day, 2g / bag

**Name:** placebo

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** hamilton depression rating scale relieved from 8-20 to ≤8

**Measure:** Depression symptoms relieved

**Time Frame:** Day0,Month3

#### Secondary Outcomes

**Description:** The increase of intestinal microbial diversity and abundance

**Measure:** Changes of intestinal microbial diversity in patients

**Time Frame:** Day0,Month3

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria

* patients with depressive symptoms after surgery for papillary thyroid carcinoma in the outpatient department of Zhejiang Cancer Hospital
* Han nationality
* No previous depression and other mental diseases
* 18-80 years old
* Women
* BMI 19 \~ 24

Exclusion Criteria

* suffering from other diseases of the intestinal system
* Gastrointestinal surgery was performed before intervention
* Including patients with other malignant tumors, who need chemotherapy, radiotherapy, biological therapy or traditional Chinese medicine treatment received antibiotics or microecological modulators within 3 months before the intervention
* Acute intestinal obstruction
* Patients with severe depressive symptoms who must receive antidepressant treatment organic diseases such as heart and brain diseases, brain trauma history of mental illness, use of psychoactive drugs such as drugs
* Severe liver and kidney dysfunction
* Pregnancy, lactation

**Maximum Age:** 80 Years

**Minimum Age:** 18 Years

**Sex:** FEMALE

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Hangzhou

**Country:** China

**Facility:** Zhejiang Cancer Hospital

**State:** Zhejiang

**Zip:** 310022

#### Overall Officials

**Official 1:**

**Affiliation:** Zhejiang Cancer Hospital

**Name:** Jinbiao Shang

**Role:** STUDY_DIRECTOR

## Document Section

### Large Document Module

#### Large Docs

- Date: 2023-03-28

- Filename: Prot_SAP_000.pdf

- Has ICF: False

- Has Protocol: True

- Has SAP: True

- Label: Study Protocol and Statistical Analysis Plan

- Size: 350832

- Type Abbrev: Prot_SAP

- Upload Date: 2024-05-15T03:08

- Date: 2023-03-28

- Filename: ICF_001.pdf

- Has ICF: True

- Has Protocol: False

- Has SAP: False

- Label: Informed Consent Form

- Size: 194352

- Type Abbrev: ICF

- Upload Date: 2024-05-15T03:09

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000001526

- Term: Behavioral Symptoms

- ID: D000019964

- Term: Mood Disorders

- ID: D000001523

- Term: Mental Disorders

- ID: D000004700

- Term: Endocrine System Diseases

- ID: D000004701

- Term: Endocrine Gland Neoplasms

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000009369

- Term: Neoplasms

- ID: D000006258

- Term: Head and Neck Neoplasms

### Condition Browse Module - Browse Branches

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: All

- Name: All Conditions

- Abbrev: BC19

- Name: Gland and Hormone Related Diseases

- Abbrev: BC04

- Name: Neoplasms

### Condition Browse Module - Browse Leaves

- ID: M7058

- Name: Depression

- Relevance: HIGH

- As Found: Depression

- ID: M16718

- Name: Thyroid Diseases

- Relevance: HIGH

- As Found: Thyroid

- ID: M7061

- Name: Depressive Disorder

- Relevance: HIGH

- As Found: Depression

- ID: M16723

- Name: Thyroid Neoplasms

- Relevance: HIGH

- As Found: Thyroid Cancer

- ID: M4818

- Name: Behavioral Symptoms

- Relevance: LOW

- As Found: Unknown

- ID: M21835

- Name: Mood Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M4815

- Name: Mental Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M14473

- Name: Psychotic Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M7862

- Name: Endocrine System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M7863

- Name: Endocrine Gland Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M9348

- Name: Head and Neck Neoplasms

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000013964

- Term: Thyroid Neoplasms

- ID: D000013959

- Term: Thyroid Diseases

- ID: D000003863

- Term: Depression

- ID: D000003866

- Term: Depressive Disorder

### Intervention Browse Module - Browse Branches

- Abbrev: HB

- Name: Herbal and Botanical

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: T274

- Name: Reishi

- Relevance: HIGH

- As Found: Northwestern

### Misc Info Module

- Version Holder: 2024-05-31
