An interventional study of Chinese medicine - Silkworm pupa powder and Ultra-low dose silkworm pupa powder in Motor Neuron Disease (MND) and Amyotrophic Lateral Sclerosis (ALS), sponsored by First People's Hospital of Hangzhou. Recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-05-04.
Sponsored by First People's Hospital of Hangzhou · Not applicable, Interventional, and Treatment
Among 54 studies in Amyotrophic Lateral Sclerosis with a site in China — 23 open to participants now, 28 under way, 1 of them phase 3. Amyotrophic Lateral Sclerosis · China.
Among the 54 studies in Amyotrophic Lateral Sclerosis with a site in China, this one is the 9th largest by planned enrollment of the 38 interventional ones that give a count, is one of 9 that started in 2025, is one of 6 with no phase, reaches primary completion later than 11 of the 27 other live ones, and was the 43rd registered.
978 studies on the registry are indexed under Amyotrophic Lateral Sclerosis; 277 are open to participants now.
Browse Amyotrophic Lateral Sclerosis studies →23 of the 54 studies in Amyotrophic Lateral Sclerosis with a site in China are open now. Recruiting first, the newest first:
Talengen Institute of Life Sciences, Shenzhen, P.R. China. · Sites in China
Ages 18+
Shanghai Zhimeng Biopharma, Inc. · Sites in China
Ages 18–65
XellSmart Bio-Pharmaceutical (Suzhou) Co., Ltd. · Sites in China
Ages 18–75
Shanghai StairMed Technology Co., Ltd. · Sites in China
Ages 18–80
Hong Chen · Sites in China
Ages 18+
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 192 Amyotrophic Lateral Sclerosis studies recruiting now, 117 (61%) set no upper age limit and 23 (12%) stop at 75 or younger; 15 take children under 18; 55 take healthy volunteers.
This study: 18 Years to 80 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
54 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 17 · Phase 2 15 · Phase 3 2 · Phase 4 3
First in 2006; this study’s year is marked. 9 started in 2025.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 100 is above the median of 38 across 662 interventional studies indexed under Amyotrophic Lateral Sclerosis.
Median enrollment 27 across the 38 interventional studies, 226 across the 16 observational. Of the 10 that completed or were terminated, 1 (10%) have results posted.
This tab as a report to print or save as PDF → With an account.
12 of 54 have an industry lead sponsor. The 10 most frequent:
First People's Hospital of Hangzhou is the lead sponsor of 73 studies on the registry; 28 are open to participants now.
First People's Hospital of Hangzhou has 1 study filed under Amyotrophic Lateral Sclerosis — fewer than ten, so there is no comparison to draw.
11 of the studies in Amyotrophic Lateral Sclerosis with a site in China that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07082192Phase 3Shanghai Zhimeng Biopharma, Inc.A Study to Evaluate the Efficacy and Safety of Different Doses of CB03-154 in Adult Patients With Amyotrophic Lateral Sclerosis (ALS) | 2027-09-30 |
| NCT06493279RJK Biopharma LtdEvaluate the Safety and Efficacy of Intrathecal Injection of RJK002 in Patients With Amyotrophic Lateral Sclerosis | 2026-11-30 |
| NCT06671236Novabio TherapeuticsClinical Study of Regulatory T Cells (Tregs) in the Treatment of Neurodegenerative Diseases | 2026-12 |
| NCT06765499First People's Hospital of HangzhouThe Study Evaluating the Improvement of Nutritional Status and Frailty With Silkworm Pupa Powder Among Patients With Motor Neuron Disease | 2026-12-30 |
| NCT06726577Talengen Institute of Life Sciences, Shenzhen, P.R. China.TP04HN106 in the Treatment of Patients With Amyotrophic Lateral Sclerosis | 2027-01 |
Add all 11 to your calendar (.ics) → With an account.
Among the 54 studies in Amyotrophic Lateral Sclerosis with a site in China, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
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.
978 studies on the registry are indexed under Amyotrophic Lateral Sclerosis; 277 are open to participants now.
This study's planned enrollment of 100 is above the median of 38 across 662 interventional studies indexed under Amyotrophic Lateral Sclerosis.
Browse Amyotrophic Lateral Sclerosis studies →First People's Hospital of Hangzhou is the lead sponsor of 73 studies on the registry; 28 are open to participants now.
Compared within Amyotrophic Lateral Sclerosis, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Motor Neuron Disease. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Other: Chinese medicine - Silkworm pupa powder
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.
Other: Ultra-low dose silkworm pupa powder
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.
0.5% of the effective components in the experimental group
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).
Time frame: 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.
Time frame: The 0th、 4th 、8th and 12th week after taking Silkworm Silkworm pupa powder.
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.
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.
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.
Time frame: The 0th、 4th 、8th and 12th week after taking Silkworm Silkworm pupa powder.
Plan to share: No
No publications or documents are linked to this record.
Started Mar 2025 (actual). Primary completion is estimated for Dec 2026, 21 months after the start.
Of 134 non-industry interventional studies with no phase under Amyotrophic Lateral Sclerosis, half reached primary completion within 40 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 60. This study's planned 21 months is below that.
Counting every sponsor, half of 154 studies reached it within 35 months; a quarter within 23 and three quarters within 60.
How these figures are worked out, and which studies are left out of them.
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Amyotrophic Lateral Sclerosis →
First People's Hospital of Hangzhou