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

NCT ID: NCT06429514

Last Updated: 2024-05-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

298 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-28

Study Completion Date

2024-05-03

Brief Summary

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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

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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

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Depression Thyroid Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Ganoderma lucidum spore powder

Intervention Type DIETARY_SUPPLEMENT

One bag at a time, 2 times a day, 2g / bag

placebo

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

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type OTHER

One bag at a time, 2 times a day, 2g / bag

Interventions

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Ganoderma lucidum spore powder

One bag at a time, 2 times a day, 2g / bag

Intervention Type DIETARY_SUPPLEMENT

placebo

One bag at a time, 2 times a day, 2g / bag

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Zhejiang Shouxiangu Pharmaceutical Co,. Ltd.

INDUSTRY

Sponsor Role collaborator

Ling Zhiqiang

OTHER

Sponsor Role lead

Responsible Party

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Ling Zhiqiang

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Jinbiao Shang

Role: STUDY_DIRECTOR

Zhejiang Cancer Hospital

Locations

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Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Site Status

Countries

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China

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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IRB-2023-307

Identifier Type: -

Identifier Source: org_study_id

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