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

May 20, 2024 updated by: Ling Zhiqiang

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

298

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310022
        • Zhejiang Cancer Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ganoderma lucidum spore powder
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
One bag at a time, 2 times a day, 2g / bag
Placebo Comparator: placebo
Oral ' placebo ' 4g per day ( 1 bag at a time, 2 times a day, 2g / bag ) for 90 days.
Other: placebo
One bag at a time, 2 times a day, 2g / bag

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ling Zhiqiang

Collaborators

Zhejiang Shouxiangu Pharmaceutical Co,. Ltd.

Investigators

  • Study Director: Jinbiao Shang, Zhejiang Cancer Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 28, 2023

Primary Completion (Actual)

May 3, 2024

Study Completion (Actual)

May 3, 2024

Study Registration Dates

First Submitted

May 15, 2024

First Submitted That Met QC Criteria

May 20, 2024

First Posted (Actual)

May 28, 2024

Study Record Updates

Last Update Posted (Actual)

May 28, 2024

Last Update Submitted That Met QC Criteria

May 20, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-2023-307

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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