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

NCT06429514 | Completed

• 1 other identifier: IRB-2023-307
• Study Type: interventional
• Target: 298
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression; Thyroid Cancer

Keywords

Depression; Thyroid Cancer; the gut-brain axis; ganoderma lucidum

Outcome Measures

Primary Outcomes (1)

• Depression symptoms relieved

  hamilton depression rating scale relieved from 8-20 to ≤8

  Day0,Month3

Secondary Outcomes (1)

• Changes of intestinal microbial diversity in patients

  Day0,Month3

Study Arms (2)

Ganoderma lucidum spore powder

EXPERIMENTAL

Oral administration of Ganoderma lucidum spore powder 4g per day ( 1 bag at a time, 2 times a day, 2g / bag ) for 90 days

Dietary Supplement: Ganoderma lucidum spore powder

placebo

PLACEBO COMPARATOR

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

Other: placebo

Interventions

Ganoderma lucidum spore powder DIETARY_SUPPLEMENT

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

Ganoderma lucidum spore powder

placebo OTHER

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

placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• years old
• Women
• BMI 19 \~ 24

You may not qualify if:

• 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

Sponsors & Collaborators

• Ling Zhiqiang: lead
• Zhejiang Shouxiangu Pharmaceutical Co,. Ltd.: collaborator

Study Sites (1)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

Location

MeSH Terms

Conditions

Depression; Thyroid Neoplasms

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases

Study Officials

• Jinbiao Shang

  Zhejiang Cancer Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: May 15, 2024
• First Posted: May 28, 2024
• Study Start: March 28, 2023
• Primary Completion: May 3, 2024
• Study Completion: May 3, 2024
• Last Updated: May 28, 2024

Record last verified: 2024-05

Locations

CN (1)