DepressionNCT07524777
Ganoderma Spores Modulate the Gut-Brain Axis
A study testing Sporoderm-removed Ganoderma lucidum spore powder (RGLS) in people with Depression and Thyroid Cancer, run by Ling Zhiqiang at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Depression, Thyroid Cancer
- What is being tested?
- Sporoderm-removed Ganoderma lucidum spore powder (RGLS)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 11 Apr 2026to 31 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Female.
Who cannot join
- 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.
- Acute intestinal obstruction.
- Patients who are currently taking antidepressant medication, or those whom the investigators judge require immediate initiation of antidepressant medication treatment.
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- Organic brain diseases, brain trauma.
- History of psychiatric disorders, use of psychoactive substances (e.g., drugs).
- Severe liver or kidney dysfunction.
- Pregnancy or lactation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Targeting the Gut-Brain Axis With Ganoderma Lucidum Spores Ameliorates Depression in Thyroid Cancer Patients: a Randomized, Double-blind, Placebo-controlled 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.
- Conditions
- Depression, Thyroid Cancer
- Being tested
- Sporoderm-removed Ganoderma lucidum spore powder (RGLS), Placebo
- Medical subject headings
- Depression, Thyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
PlaceboOther
From the first day after enrollment, subjects take placebo orally at 4g/day for 3 months.
| Study group | Role | What they receive |
|---|---|---|
| Sporoderm-removed Ganoderma lucidum spore powder (RGLS) | Experimental | Not described Receives: Dietary Supplement: Sporoderm-removed Ganoderma lucidum spore powder (RGLS) |
| placebo group | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Hamilton Depression Rating Scale-24（HAMD-24）score from baseline to 3 months of RGLS intervention
Measured: 3 months
Secondary outcomes (3)
Change in Pittsburgh Sleep Quality Index (PSQI) score from baseline to 3 months of RGLS intervention.
Measured: 3 months
Changes in gut microbial species from baseline to 3 months of RGLS intervention.
Measured: 3 months
Change in serum metabolites from baseline to 3 months of RGLS intervention.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start11 Apr 2026
- Primary completion31 Jul 2026
- Study completion31 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ling Zhiqiang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ling Zhiqiang, Zhejiang Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07524777
- Sponsor's protocol ID
- IRB-2026-288（IIT）
- Status last verified
- Aug 2026
- First submitted
- 1 Apr 2026
- Last updated
- 28 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeting the Gut-Brain Axis With Ganoderma Lucidum Spores Ameliorates Depression in Thyroid Cancer Patients: a Randomized, Double-blind, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT07524777
- Acronym / sponsor ID
- IRB-2026-288（IIT）
- Conditions
- Depression, Thyroid Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Ling ZhiqiangUniversity, hospital or other
- Study start
- 11 Apr 2026 (actual)
- Primary completion
- 31 Jul 2026 (actual)
- Study completion
- 31 Jul 2026 (actual)
- First posted
- 13 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sporoderm-removed Ganoderma lucidum spore powder (RGLS) | Experimental | Dietary Supplement: Sporoderm-removed Ganoderma lucidum spore powder (RGLS) |
| placebo group | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
- Female.
Key exclusion criteria (10 listed)
- 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.
- Acute intestinal obstruction.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sporoderm-removed Ganoderma lucidum spore powder (RGLS)From the first day after enrollment, subjects take RGLS orally at 4g/day for 3 months. | Dietary supplement | Sporoderm-removed Ganoderma lucidum spore powder (RGLS) |
| PlaceboFrom the first day after enrollment, subjects take placebo orally at 4g/day for 3 months. | Other | placebo group |
Primary outcome
Change in Hamilton Depression Rating Scale-24（HAMD-24）score from baseline to 3 months of RGLS intervention
Time frame: 3 months
3 secondary outcomes
Change in Pittsburgh Sleep Quality Index (PSQI) score from baseline to 3 months of RGLS intervention.
Time frame: 3 months
Changes in gut microbial species from baseline to 3 months of RGLS intervention.
Time frame: 3 months
Change in serum metabolites from baseline to 3 months of RGLS intervention.
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sporoderm-removed Ganoderma lucidum spore powder (RGLS) in people with Depression and Thyroid Cancer, run by Ling Zhiqiang at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Hamilton Depression Rating Scale-24（HAMD-24）score from baseline to 3 months of RGLS intervention (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2026.