Clinical trial NCT06429514: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Thyroid Cancer
Keywords: Depression
Thyroid Cancer
the gut-brain axis
ganoderma lucidum
Lead sponsor: Zhejiang Cancer Hospital
Sponsor class: OTHER
Collaborators: name: Zhejiang Shouxiangu Pharmaceutical Co,. Ltd.
First posted: 2024-05-28
Enrollment: 298
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Depression symptoms relieved
timeFrame: Day0,Month3
Secondary outcomes:
measure: Changes of intestinal microbial diversity in patients
timeFrame: Day0,Month3
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
Study officials:
affiliation: Zhejiang Cancer Hospital
name: Jinbiao Shang
role: STUDY_DIRECTOR
References: