Health TrialsbyHealthPanel

Ganoderma Spores Modulate the Gut-Brain Axis

ConditionsDepressionThyroid Cancer
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Sporoderm-removed Ganoderma lucidum spore powder (RGLS)

    Dietary supplement

    From the first day after enrollment, subjects take RGLS orally at 4g/day for 3 months.

  • Placebo

    Other intervention

    From the first day after enrollment, subjects take placebo orally at 4g/day for 3 months.

Treatment groups

300 Participants
are divided into 2 treatment groups
Group A: Sporoderm-removed Ganoderma lucidum spore powder (RGLS)Experimental treatment 1 intervention
Group B: placebo groupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in Hamilton Depression Rating Scale-24（HAMD-24）score from baseline to 3 months of RGLS intervention

Time frame
3 months

Secondary outcomes

1

Change in Pittsburgh Sleep Quality Index (PSQI) score from baseline to 3 months of RGLS intervention.

Time frame
3 months
2

Changes in gut microbial species from baseline to 3 months of RGLS intervention.

Time frame
3 months
3

Change in serum metabolites from baseline to 3 months of RGLS intervention.

Time frame
3 months

Other outcomes

1

Incidence of adverse events in both groups, including patient-reported symptoms and laboratory parameters.

Time frame
3 months
2

Improvement rate of thyroid function in both groups, assessed by thyroid function parameters.

Time frame
3 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ling Zhiqiang

Lead sponsor

Zhejiang Cancer Hospital

Sponsor institution

Source ClinicalTrials.gov
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