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NCT Number: NCT06429514

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

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.

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Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ganoderma lucidum spore powder

Dietary Supplement

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

Placebo

Other

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

Primary outcomes

  1. Depression symptoms relieved

    Time frame: Day0,Month3

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

Secondary outcomes

  1. Changes of intestinal microbial diversity in patients

    Time frame: Day0,Month3

    The increase of intestinal microbial diversity and abundance

Sponsors and collaborators

Lead sponsor

Ling Zhiqiang

Other

Collaborators

  • Zhejiang Shouxiangu Pharmaceutical Co,. Ltd.

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
May 28, 2024
Registry last updated
May 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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