DepressionNCT06429514
Study on the Mechanism of Ganoderma Lucidum Spore Powder in the Treatment of Depression
A study testing Ganoderma lucidum spore powder in people with Depression and Thyroid Cancer, run by Ling Zhiqiang at 1 site in China.
Trial 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. 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?
- Ganoderma lucidum spore powder
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 298 participants
- Where
- 1 siteChina
- Study dates
- 28 Mar 2023to 3 May 2024
- 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
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
Read the detailed description
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.
- Conditions
- Depression, Thyroid Cancer
- Being tested
- Ganoderma lucidum spore powder, placebo
- Keywords
- Depression, Thyroid Cancer, the gut-brain axis, ganoderma lucidum
- 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.
Ganoderma lucidum spore powderDietary supplement
One bag at a time, 2 times a day, 2g / bag
placeboOther
One bag at a time, 2 times a day, 2g / bag
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression symptoms relieved
hamilton depression rating scale relieved from 8-20 to ≤8
Measured: Day0,Month3
Secondary outcomes (1)
Changes of intestinal microbial diversity in patients
The increase of intestinal microbial diversity and abundance
Measured: Day0,Month3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2024
- Study start28 Mar 2023
- Primary completion3 May 2024
- Study completion3 May 2024
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
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 298 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ling Zhiqiang
- Sponsor type
- University, hospital or other
- Collaborators
- Zhejiang Shouxiangu Pharmaceutical Co,. Ltd.
- Responsible party
- Sponsor-investigator, Ling Zhiqiang, Zhejiang Cancer Hospital
- Investigators
- Jinbiao Shang, Study director, Zhejiang Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06429514
- Sponsor's protocol ID
- IRB-2023-307
- Status last verified
- May 2024
- First submitted
- 15 May 2024
- Last updated
- 28 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06429514
- Acronym / sponsor ID
- IRB-2023-307
- Conditions
- Depression, Thyroid Cancer
- Keywords
- Depression, Thyroid Cancer, the gut-brain axis, ganoderma lucidum
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 298 participants (actual)
- Lead sponsor
- Ling ZhiqiangUniversity, hospital or other
- Collaborators
- Zhejiang Shouxiangu Pharmaceutical Co,. Ltd.
- Study start
- 28 Mar 2023 (actual)
- Primary completion
- 3 May 2024 (actual)
- Study completion
- 3 May 2024 (actual)
- First posted
- 28 May 2024 (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.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Ganoderma lucidum spore powder | Experimental | Dietary Supplement: Ganoderma lucidum spore powderOral administration of Ganoderma lucidum spore powder 4g per day ( 1 bag at a time, 2 times a day, 2g / bag ) for 90 days |
| placebo | Placebo comparator | Other: placeboOral ' placebo ' 4g per day ( 1 bag at a time, 2 times a day, 2g / bag ) for 90 days. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
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 |
|---|---|---|
| Ganoderma lucidum spore powderOne bag at a time, 2 times a day, 2g / bag | Dietary supplement | Ganoderma lucidum spore powder |
| placeboOne bag at a time, 2 times a day, 2g / bag | Other | placebo |
Primary outcome
Depression symptoms relieved
Time frame: Day0,Month3
hamilton depression rating scale relieved from 8-20 to ≤8
1 secondary outcome
Changes of intestinal microbial diversity in patients
Time frame: Day0,Month3
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 May 2024.
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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.
Jinbiao Shang study director
Zhejiang Cancer Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ganoderma lucidum spore powder 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 6 inclusion and 7 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 May 2024. 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?
Depression symptoms relieved (time frame: Day0,Month3). 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 May 2024.