Depression, Thyroid Cancer
Conditions
Keywords
Depression, Thyroid Cancer, the gut-brain axis, ganoderma lucidum
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.
Interventions
DIETARY_SUPPLEMENTGanoderma lucidum spore powder
One bag at a time, 2 times a day, 2g / bag
OTHERplacebo
One bag at a time, 2 times a day, 2g / bag
Sponsors
Zhejiang Shouxiangu Pharmaceutical Co,. Ltd.
Ling Zhiqiang
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Depression symptoms relieved | Day0,Month3 | hamilton depression rating scale relieved from 8-20 to ≤8 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes of intestinal microbial diversity in patients | Day0,Month3 | The increase of intestinal microbial diversity and abundance |
Countries
China
Outcome results
None listed