Motor Neuron Disease (MND)NCT06765499
The Study Evaluating the Improvement of Nutritional Status and Frailty With Silkworm Pupa Powder Among Patients With Motor Neuron Disease
A study testing Chinese medicine - Silkworm pupa powder and Ultra-low dose silkworm pupa powder in people with Motor Neuron Disease (MND) and Amyotrophic Lateral Sclerosis (ALS), run by First People's Hospital of Hangzhou at 1 site in China.
Trial summary
Motor Neuron Disease (MND) is the result of dysfunction of the upper motor neurons in the precentral gyrus of the frontal lobe or the lower motor neurons in the ventral horn of the spinal cord. Amyotrophic lateral sclerosis (ALS) is the most common, disabling, and fatal motor neuron disease in adults. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Motor Neuron Disease (MND), Amyotrophic Lateral Sclerosis (ALS)
- What is being tested?
- Chinese medicine - Silkworm pupa powder and Ultra-low dose silkworm pupa powder
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 4 Mar 2025to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntarily participate in the clinical study, fully understand and be informed about the study, and sign the Informed Consent Form (ICF); willing to follow and capable of completing all trial procedures.
- Gender is not limited, age at the time of signing ICF: ≥18 years old, ≤80 years old; if the ALS patient is at least 18 years old, then the weight must be over 40 kilograms.
- Diagnosis conforms to the confirmed and probable ALS in the ALS2020 diagnostic criteria (Gold Coast Criteria).
- Clinical, neurophysiological, or pathological examination confirms evidence of lower motor neuron involvement.
- Frailty Phenotype scale (FP) ≥1.
- Exclude other diseases.
- Agree to provide peripheral blood, fecal, and urine samples for biomarker analysis during the study period.
Who cannot join
- Patients with other neurological diseases similar to ALS symptoms or affecting drug efficacy evaluation, such as cervical spondylosis, lumbar disease, dementia, etc.
- Patients with other autoimmune diseases, such as Multiple Sclerosis (MS), Polymyositis, Myasthenia Gravis, Guillain-Barré Syndrome, Ankylosing Spondylitis, Rheumatoid Arthritis, Systemic Lupus Erythematosus, Vitiligo, etc.
- Severe renal insufficiency: Creatinine clearance < 30 mL/min (Cockcroft-Gault formula), or other known severe renal insufficiency diseases.
- Severe liver damage: ALT, AST > 3 times the upper limit of normal, or other known liver diseases such as acute and chronic active hepatitis, cirrhosis, etc.
- Patients with severe pulmonary function insufficiency such as Chronic Obstructive Pulmonary Disease (COPD), pulmonary fibrosis, etc.
- During the screening period, patients with acute myocardial infarction or interventional treatment within the last 6 months, heart failure patients (classified as NYHA class III-IV patients).
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- Patients with other severe primary diseases of the nervous system, heart, lungs, hematopoietic system, or endocrine system, and mental illness patients.
- Those suspected or confirmed to have a history of alcohol or drug abuse.
- Expected survival ≤ 3 months.
- Pregnant or breastfeeding women, subjects of reproductive age (including male subjects who have had heterosexual intercourse and their female partners with childbearing potential) who plan to become pregnant or are unwilling to take effective contraceptive measures from the start of screening to 3 months after discontinuing medication.
- Those who are allergic to known ingredients of the trial products; or have a history of drug allergies or severe allergic diseases (anaphylactic shock, etc.).
- During the study, individuals assessed by researchers as potential drug abusers who may affect the efficacy of therapeutic drugs.
- Presence of other severe physical or mental diseases or abnormal laboratory tests that may increase the risk of participating in the study and patients deemed unsuitable for participation by the researcher.
- Patients with malignant tumors.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Hangzhou First People's Hospital
Hangzhou, Zhejiang, 310000
Ma Buqing MM, 057156007429, 757318708@qq.com
About this study
Official title: A Prospective, Double-blind, Randomized Controlled Study Evaluating the Improvement of Nutritional Status and Frailty With Silkworm Pupa Powder Compared With Placebo Among Motor Neuron Disease
Motor Neuron Disease (MND) is the result of dysfunction of the upper motor neurons in the precentral gyrus of the frontal lobe or the lower motor neurons in the ventral horn of the spinal cord. Amyotrophic lateral sclerosis (ALS) is the most common, disabling, and fatal motor neuron disease in adults. Sarcopenia is a syndrome characterized by progressive loss of skeletal muscle mass, accompanied by a reduction in muscle strength and (or) function, and it is an important feature of MND. Aging is an objective and inevitable process that involves the gradual degeneration and loss of physiological functions in various tissues, organs, and cells. With the continuous accumulation of various injuries, the body eventually exhibits signs of frailty such as fatigue, reduced muscle strength, and weight loss. Data from adult ALS patients indicate that 58% of patients are at risk of frailty. Silkworm pupa contains high-quality animal protein and has a wide range of activities in antioxidant, antitumor, antibacterial, and immune enhancement, making it highly nutritious and medicinally valuable. Silkworm pupa extracts can enhance grip strength in older adults with relatively low skeletal muscle mass. As a natural food ingredient with high safety, the value of silkworm pupa in ALS patients lacks corresponding research, which limits its further application in clinical practice. This study aims to select ALS patients as the research subjects and use a randomized, controlled, double-blind prospective study design to evaluate the effectiveness of silkworm pupa tablets in improving sarcopenia, frailty, and quality of life in ALS patients. The study strives to improve the frailty condition of ALS patients and enhance their quality of life by supplementing nutrition, thereby providing new strategies for comprehensive intervention and management of ALS patients.
- Being tested
- Chinese medicine - Silkworm pupa powder, Ultra-low dose silkworm pupa powder
- Keywords
- Amyotrophic Lateral Sclerosis, Motor Neuron Disease, Frailty, Nutritional Status
- Medical subject headings
- Motor Neuron Disease, Amyotrophic Lateral Sclerosis, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chinese medicine - Silkworm pupa powderOther
Silkworm pupa contains high-quality animal protein and has a wide range of activities in antioxidant, antitumor, antibacterial, and immune enhancement, making it highly nutritious and medicinally valuable.
Ultra-low dose silkworm pupa powderOther
0.5% of the effective components in the experimental group
| Study group | Role | What they receive |
|---|---|---|
| Silkworm pupa powder | Experimental | The intervention in the trial involves providing silkworm pupa powder, twice a day, with two packets each time, to be taken before meals.The dose of gastrointestinal weak people was halved, twice a day, 1 pack each time, half an hour before breakfast and dinner. Receives: Other: Chinese medicine - Silkworm pupa powder |
| Placebo | Placebo comparator | The intervention for the placebo group involves administering a placebo containing 0.5% of the active ingredient, twice daily, with two packets each time, taken before meals.The dose of gastrointestinal weak people was halved, twice a day, 1 pack each time, half an hour before breakfast and dinner. Receives: Other: Ultra-low dose silkworm pupa powder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessing patient nutritional improvement using Third Lumbar Skeletal Muscle Index (L3-SMI).
The nutritional index is evaluated using the Third Lumbar Skeletal Muscle Index (L3-SMI): A single cross-sectional image of L3 is obtained through CT scanning, and skeletal muscles in the image are identified and quantified using a HU threshold of -29 to 150. The total muscle area at this level is calculated using 3D Slicer software, and then divided by the square of the height (m^2) to obtain the Third Lumbar Skeletal Muscle Index (L3-SMI).
Measured: The 0th、 4th 、8th and 12th week after taking Silkworm Silkworm pupa powder.
The improvement of frailty in patients treated by the Frailty Phenotype (FP) Scale assessment.
Frailty Phenotype Scale: The Frailty Phenotype (FP) Scale encompasses the following five clinical criteria:
- Unintentional Weight Loss
- Self-reported Fatigue
- Decreased Physical Activity
- Slowed Gait Speed
- Weak Grip Strength Each criterion is scored as 1 point if met, with a total score ranging from 0 to 5. A score of 0 indicates robust health, a score of 1 to 2 indicates pre-frailty, and a score of 3 or higher indicates frailty.
This scale is used to assess the frailty status of individuals, providing a separate outcome measure that focuses on the physical vulnerability and decreased resilience commonly associated with aging.
Measured: The 0th、 4th 、8th and 12th week after taking Silkworm Silkworm pupa powder.
Secondary outcomes (2)
Using the Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R) to assess patient functional status, thereby evaluating the improvement of neurological dysfunction.
Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R) consists of 12 items with a total score of 48 points, where each item is rated from 0 to 4, with 0 indicating complete loss of function and 4 indicating normal function.
The minimum score is 0 points, which indicates that the patient is completely unable to perform any of the tasks listed in the scale, while the maximum score is 48 points, indicating that the patient can perform all tasks normally.
A higher score implies better functional status in the patient, meaning less severe neurological impairment; a lower score indicates worse functional status, meaning more severe neurological impairment.
This scale is a specific tool for evaluating the functional status of patients with Amyotrophic Lateral Sclerosis, offering a distinct outcome measure that quantifies the progression of the disease.
Measured: The 0th、 4th 、8th and 12th week after taking Silkworm Silkworm pupa powder.
Assess the respiratory function of patients with Amyotrophic Lateral Sclerosis undergoing treatment using the Oxygenation Index.
Oxygenation Index: The Oxygenation Index combines arterial oxygen partial pressure (PaO2) and inspired oxygen fraction (FiO2), calculated using the formula Oxygenation Index (mmHg) = PaO2 (mmHg) / FiO2 (%). It provides a single value indicating a patient's oxygenation status relative to the oxygen concentration they are breathing, thereby characterizing respiratory function. During the treatment process, the change coefficients of the Oxygenation Index after intervention in the silkworm pupa treatment group and the placebo group are calculated, using this coefficient to characterize the relief ratio of respiratory function following Silkworm pupa powder intervention.
Measured: The 0th、 4th 、8th and 12th week after taking Silkworm Silkworm pupa powder.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2025
- Study start4 Mar 2025
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Motor Neuron Disease (MND)Studies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First People's Hospital of Hangzhou
- Sponsor type
- University, hospital or other
- Collaborators
- Hangzhou Institute of Medicine (HIM), Chinese Academy of Sciences
- Responsible party
- Principal investigator, Buqing Ma, M.M., First People's Hospital of Hangzhou
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06765499
- Sponsor's protocol ID
- ZN-2024308-02
- Status last verified
- Jan 2025
- First submitted
- 11 Dec 2024
- Last updated
- 4 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Double-blind, Randomized Controlled Study Evaluating the Improvement of Nutritional Status and Frailty With Silkworm Pupa Powder Compared With Placebo Among Motor Neuron Disease
- ClinicalTrials.gov ID
- NCT06765499
- Acronym / sponsor ID
- ZN-2024308-02
- Keywords
- Amyotrophic Lateral Sclerosis, Motor Neuron Disease, Frailty, Nutritional Status
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- First People's Hospital of HangzhouUniversity, hospital or other
- Collaborators
- Hangzhou Institute of Medicine (HIM), Chinese Academy of Sciences
- Study start
- 4 Mar 2025 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 9 Jan 2025 (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.
Motor Neuron Disease (MND) is the result of dysfunction of the upper motor neurons in the precentral gyrus of the frontal lobe or the lower motor neurons in the ventral horn of the spinal cord. Amyotrophic lateral sclerosis (ALS) is the most common, disabling, and fatal motor neuron disease in adults. Sarcopenia is a syndrome characterized by progressive loss of skeletal muscle mass, accompanied by a reduction in muscle strength and (or) function, and it is an important feature of MND. Aging is an objective and inevitable process that involves the gradual degeneration and loss of physiological functions in various tissues, organs, and cells. With the continuous accumulation of various injuries, the body eventually exhibits signs of frailty such as fatigue, reduced muscle strength, and weight loss. Data from adult ALS patients indicate that 58% of patients are at risk of frailty. Silkworm pupa contains high-quality animal protein and has a wide range of activities in antioxidant, antitumor, antibacterial, and immune enhancement, making it highly nutritious and medicinally valuable. Silkworm pupa extracts can enhance grip strength in older adults with relatively low skeletal muscle mass. As a natural food ingredient with high safety, the value of silkworm pupa in ALS patients lacks corresponding research, which limits its further application in clinical practice. This study aims to select ALS patients as the research subjects and use a randomized, controlled, double-blind prospective study design to evaluate the effectiveness of silkworm pupa tablets in improving sarcopenia, frailty, and quality of life in ALS patients. The study strives to improve the frailty condition of ALS patients and enhance their quality of life by supplementing nutrition, thereby providing new strategies for comprehensive intervention and management of ALS patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Silkworm pupa powder | Experimental | Other: Chinese medicine - Silkworm pupa powderThe intervention in the trial involves providing silkworm pupa powder, twice a day, with two packets each time, to be taken before meals.The dose of gastrointestinal weak people was halved, twice a day, 1 pack each time, half an hour before breakfast and dinner. |
| Placebo | Placebo comparator | Other: Ultra-low dose silkworm pupa powderThe intervention for the placebo group involves administering a placebo containing 0.5% of the active ingredient, twice daily, with two packets each time, taken before meals.The dose of gastrointestinal weak people was halved, twice a day, 1 pack each time, half an hour before breakfast and dinner. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Voluntarily participate in the clinical study, fully understand and be informed about the study, and sign the Informed Consent Form (ICF); willing to follow and capable of completing all trial procedures.
- Gender is not limited, age at the time of signing ICF: ≥18 years old, ≤80 years old; if the ALS patient is at least 18 years old, then the weight must be over 40 kilograms.
- Diagnosis conforms to the confirmed and probable ALS in the ALS2020 diagnostic criteria (Gold Coast Criteria).
- Clinical, neurophysiological, or pathological examination confirms evidence of lower motor neuron involvement.
- Frailty Phenotype scale (FP) ≥1.
Key exclusion criteria (14 listed)
- Patients with other neurological diseases similar to ALS symptoms or affecting drug efficacy evaluation, such as cervical spondylosis, lumbar disease, dementia, etc.
- Patients with other autoimmune diseases, such as Multiple Sclerosis (MS), Polymyositis, Myasthenia Gravis, Guillain-Barré Syndrome, Ankylosing Spondylitis, Rheumatoid Arthritis, Systemic Lupus Erythematosus, Vitiligo, etc.
- Severe renal insufficiency: Creatinine clearance < 30 mL/min (Cockcroft-Gault formula), or other known severe renal insufficiency diseases.
- Severe liver damage: ALT, AST > 3 times the upper limit of normal, or other known liver diseases such as acute and chronic active hepatitis, cirrhosis, etc.
- Patients with severe pulmonary function insufficiency such as Chronic Obstructive Pulmonary Disease (COPD), pulmonary fibrosis, etc.
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 |
|---|---|---|
| Chinese medicine - Silkworm pupa powderSilkworm pupa contains high-quality animal protein and has a wide range of activities in antioxidant, antitumor, antibacterial, and immune enhancement, making it highly nutritious and medicinally valuable. | Other | Silkworm pupa powder |
| Ultra-low dose silkworm pupa powder0.5% of the effective components in the experimental group | Other | Placebo |
Primary outcome
Assessing patient nutritional improvement using Third Lumbar Skeletal Muscle Index (L3-SMI).
Time frame: The 0th、 4th 、8th and 12th week after taking Silkworm Silkworm pupa powder.
The nutritional index is evaluated using the Third Lumbar Skeletal Muscle Index (L3-SMI): A single cross-sectional image of L3 is obtained through CT scanning, and skeletal muscles in the image are identified and quantified using a HU threshold of -29 to 150. The total muscle area at this level is calculated using 3D Slicer software, and then divided by the square of the height (m^2) to obtain the Third Lumbar Skeletal Muscle Index (L3-SMI).
The improvement of frailty in patients treated by the Frailty Phenotype (FP) Scale assessment.
Time frame: The 0th、 4th 、8th and 12th week after taking Silkworm Silkworm pupa powder.
Frailty Phenotype Scale: The Frailty Phenotype (FP) Scale encompasses the following five clinical criteria: * Unintentional Weight Loss * Self-reported Fatigue * Decreased Physical Activity * Slowed Gait Speed * Weak Grip Strength Each criterion is scored as 1 point if met, with a total score ranging from 0 to 5. A score of 0 indicates robust health, a score of 1 to 2 indicates pre-frailty, and a score of 3 or higher indicates frailty. This scale is used to assess the frailty status of individuals, providing a separate outcome measure that focuses on the physical vulnerability and decreased resilience commonly associated with aging.
2 secondary outcomes
Using the Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R) to assess patient functional status, thereby evaluating the improvement of neurological dysfunction.
Time frame: The 0th、 4th 、8th and 12th week after taking Silkworm Silkworm pupa powder.
Assess the respiratory function of patients with Amyotrophic Lateral Sclerosis undergoing treatment using the Oxygenation Index.
Time frame: The 0th、 4th 、8th and 12th week after taking Silkworm Silkworm pupa powder.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chinese medicine - Silkworm pupa powder and Ultra-low dose silkworm pupa powder in people with Motor Neuron Disease (MND) and Amyotrophic Lateral Sclerosis (ALS), run by First People's Hospital of Hangzhou 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 7 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 4 May 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ma Buqing Attending Physician (0571-56007429, 757318708@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessing patient nutritional improvement using Third Lumbar Skeletal Muscle Index (L3-SMI). (time frame: The 0th、 4th 、8th and 12th week after taking Silkworm Silkworm pupa powder.). The study lists 2 primary outcomes in all. 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 4 May 2025.