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Effect of Silkworm Pupa Tablets in Gastrointestinal Malignancies at Nutritional Risk Following Radical Surgery
Sponsor: Xiaosun Liu, MD
Summary
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
120
Start Date
2024-08-14
Completion Date
2025-11
Last Updated
2025-08-12
Healthy Volunteers
No
Interventions
Silkworm pupa tablets
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.
Control product
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.
Locations (4)
Affiliated Hangzhou First People's Hospital, School of Medicine, Westlake University
Hangzhou, Zhejiang, China
The First Affiliated Hospital, College of Medicine, Zhejiang University
Hangzhou, Zhejiang, China
The Second Affiliated Hospital, College of Medicine, Zhejiang University
Hangzhou, Zhejiang, China
Hangzhou Institute of Medicine Chinese Academy of Sciences
Hangzhou, China