Ganoderma Spores Modulate the Gut-Brain Axis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-80
SponsorLing Zhiqiang
About this trial
This study aims to investigate whether Sporoderm-removed Ganoderma lucidum spore powder (RGLS) ameliorates depression in thyroid cancer patients through gut-brain axis modulation, and to elucidate the underlying microbial and metabolic mechanisms. This 3-month randomized, double-blind, placebo-controlled trial will enroll 300 postoperative papillary thyroid carcinoma patients with depressive symptoms (HAMD-24 ≥ 8). Participants will be randomly assigned(2 : 1) to receive RGLS (4 g/day) or matched placebo.
Eligibility criteria
Qualifiers
Outpatients at Zhejiang Cancer Hospital with histologically confirmed papillary thyroid carcinoma (post-surgery) and depressive symptoms (HAMD-24 score ≥ 8, confirmed by a clinical psychologist).
Han Chinese ethnicity.
No history of depression or other psychiatric disorders.
Age 18-80 years.
Disqualifiers
Suffering from other gastrointestinal system diseases.
History of gastrointestinal surgery prior to intervention.
Including those with other concurrent malignancies requiring chemotherapy, radiotherapy, biological therapy, or traditional Chinese medicine treatment.
Received antibiotic treatment or microecological modulators within 3 months prior to intervention.
Trial design
Treatments tested in this trial
- Sporoderm-removed Ganoderma lucidum spore powder (RGLS)
- Placebo
Treatment groups
300 Participants
are divided into 2 treatment groupsSponsors and collaborators
Ling Zhiqiang
Lead sponsor
Zhejiang Cancer Hospital
Sponsor institution
Source ClinicalTrials.gov