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

Ling Zhiqiang

Status: Completed

Conditions: Thyroid Cancer; Depression

Treatments: Dietary Supplement: Ganoderma lucidum spore powder; Other: placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06429514

IRB-2023-307

Details and patient eligibility

About

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.

Full 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.

Enrollment: 298 patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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298 participants in 2 patient groups, including a placebo group

Ganoderma lucidum spore powder

Experimental group

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

Treatment:

Dietary Supplement: Ganoderma lucidum spore powder

placebo

Placebo Comparator group

Description:

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

Treatment:

Other: placebo