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

Depression Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06429514
• Other study ID #: IRB-2023-307
• Status: Completed
• Phase: N/A
• Start date: March 28, 2023
• Est. completion date: May 3, 2024

Study information

• Verified date: May 2024
• Source: Zhejiang Cancer Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 298
• Est. completion date: May 3, 2024
• Est. primary completion date: May 3, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Thyroid Cancer
• Thyroid Diseases
• Thyroid Neoplasms

Intervention

Dietary Supplement:
• Ganoderma lucidum spore powder
One bag at a time, 2 times a day, 2g / bag

Other:
• placebo
One bag at a time, 2 times a day, 2g / bag

Locations

Country	Name	City	State
China	Zhejiang Cancer Hospital	Hangzhou	Zhejiang

Sponsors (2)

Lead Sponsor	Collaborator
Ling Zhiqiang	Zhejiang Shouxiangu Pharmaceutical Co,. Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Depression symptoms relieved	hamilton depression rating scale relieved from 8-20 to =8	Day0,Month3
Secondary	Changes of intestinal microbial diversity in patients	The increase of intestinal microbial diversity and abundance	Day0,Month3