An interventional study of Silkworm pupa tablets and Control product in Nutritional Deficiency, Gastrointestinal Cancer and Frailty Syndrome, sponsored by Xiaosun Liu, MD. Completed at 4 sites in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-05-27.
Sponsored by Xiaosun Liu, MD · Not applicable, Interventional, and Treatment
This is a randomized, double-blind, very low dose parallel-controlled, prospective, multi-center trial evaluating the improvement of nutritional status and frailty with silkworm pupa tablets after radical resection of gastrointestinal malignancies for 3 months intervention. The primary endpoints are body weight and frailty prevalence, The secondary endpoints are body mass index (BMI), skeletal muscle index (SMI) at the third lumbar vertebra (L3-SMI), sarcopenia prevalence and quality of life.
Previous study has indicated that silkworms pupae extracts may increase muscle mass and strength, here we conduct a randomized, double-blind, very low dose parallel-controlled, prospective, multi-center trial.
1,587 studies on the registry are indexed under Malnutrition; 237 are open to participants now.
This study's enrollment of 120 is above the median of 90 across 1,134 interventional studies indexed under Malnutrition.
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Exclusion Criteria:
Wanshililongbao silkworm pupa tablets.
Dietary Supplement: Silkworm pupa tablets
Contains 0.5% of the active ingredient of the study product, indistinguishable in appearance.
Dietary Supplement: Control product
Participants will begin taking the silkworm pupa tablets immediately upon enrollment, 1200mg/tablet, two tablets a time, twice a day (BID), with a treatment duration of three months.
The sham comparator contains 0.5% of the active ingredient of the study product, indistinguishable in appearance. Participants will begin taking the control immediately upon enrollment, 1200mg/tablet, two tablets a time, twice a day (BID), with a treatment duration of three months.
Body weight
Measured at baseline and 1 month, 2 months, 3 months after enrollment
Time frame: 3 months
Frailty prevalence
The incidence of frailty, using Fried frailty phenotype to assess physical frailty, measured at baseline and 1 month, 2 months, 3 months after enrollment
Time frame: 3 months
Body mass index (BMI)
Calculated as weight (kg)/height (m2), measured at baseline and 1 month, 2 months, 3 months after enrollment
Time frame: 3 months
L3-SMI
Derived as the ratio of skeletal muscle area (SMA) to height \[SMA (cm2)/height (m2)\], at the third lumbar vertebra, measured at baseline and after 3 months
Time frame: 3 months
Sarcopenia prevalence
The incidence of sarcopenia, using the diagnostic criteria for sarcopenia published by the Asian Sarcopenia Working Group (AWGS) in 2019 or L3-SMI criteria, measured at baseline and 1 month, 2 months, 3 months after enrollment
Time frame: 3 months
Quality of life
Using the questionnaire of EORTC QLQ-C30 measured at baseline and 1 month, 2 months, 3 months after enrollment
Time frame: 3 months
Quality of life
Using the questionnaire of EORTC QLQ-STO22, measured at baseline and 1 month, 2 months, 3 months after enrollment
Time frame: 3 months
Plan to share: No
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This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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