Study on the Mechanism of Ganoderma Lucidum Spore Powder... | NCT06429514

Studies
Study on the Mechanism of Ganoderma Lucidum Spore Powder in the Treatment of Depression

NCT06429514

Sponsor

Ling Zhiqiang

Status

Completed

Last Update Posted

May 28, 2024Actual

Enrollment

298Actual

Phase

Not Applicable

Conditions

Depression
Thyroid Cancer

Interventions

Ganoderma lucidum spore powder
placebo

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 28, 2023Actual

Primary Completion Date

May 3, 2024Actual

Completion Date

May 3, 2024Actual

First Submitted Date

May 15, 2024

First Submission Date that Met QC Criteria

May 20, 2024

First Posted Date

May 28, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 20, 2024

Last Update Posted Date

May 28, 2024Actual

Name	Class
Zhejiang Shouxiangu Pharmaceutical Co,. Ltd.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

298Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Ganoderma lucidum spore powder	Experimental	Oral administration of Ganoderma lucidum spore powder 4g per day ( 1 bag at a time, 2 times a day, 2g / bag ) for 90 days	Dietary Supplement: Ganoderma lucidum spore powder
placebo	Placebo Comparator	Oral ' placebo ' 4g per day ( 1 bag at a time, 2 times a day, 2g / bag ) for 90 days.	Other: placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ganoderma lucidum spore powder	Dietary Supplement	One bag at a time, 2 times a day, 2g / bag	Ganoderma lucidum spore powder

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Depression symptoms relieved	hamilton depression rating scale relieved from 8-20 to ≤8	Day0,Month3

Secondary Outcomes

Measure	Description	Time Frame
Changes of intestinal microbial diversity in patients	The increase of intestinal microbial diversity and abundance	Day0,Month3

Other Outcomes

Not provided

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jinbiao Shang	Zhejiang Cancer Hospital	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Zhejiang Cancer Hospital		Hangzhou	Zhejiang	310022	China

Uploaded Document Information

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Mar 28, 2023	May 15, 2024	Prot_SAP_000.pdf
ICF	No	No	Yes	Informed Consent Form	Mar 28, 2023	May 15, 2024	ICF_001.pdf

Condition Browse Module

MeSH Terms

ID	Term
D003863	Depression
D013964	Thyroid Neoplasms

Ancestor Terms

ID	Term
D001526	Behavioral Symptoms
D001519	Behavior
D004701	Endocrine Gland Neoplasms
D009371	Neoplasms by Site

Browse Leaves

Not provided

Browse Branches

Not provided

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.