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A Randomized, Double-blind, Placebo-controlled, Prospective, Multi-center Trial Evaluating the Improvement of Nutritional Status and Sarcopenia With Silkworm Pupa Tablets in Patients With Malignancies
Sponsor: First Affiliated Hospital of Zhejiang University
Summary
This is a randomized, double-blind, placebo-controlled, parallel-group, prospective, multi-center clinical trial, to evaluate the efficacy of silkworm pupa tablets in improving nutritional status and sarcopenia in patients with malignancies who have completed comprehensive treatment. All participants will be randomly assigned (1:1) to either experimental group (n=240): dietary advice + Wanshili Longbao Silkworm Pupa Tablets (main ingredients: freeze-dried active mulberry cocoon pupa powder, maltitol, milk mineral salt, mannitol, maltodextrin), 2 tablets three times daily before meals for 3 months, or control group (n=240): dietary advice + placebo (identical appearance), 2 tablets three times daily before meals for 3 months. The primary endpoint is sarcopenia prevalence at 3 months (based on AWGS 2019 criteria: muscle strength, muscle mass, and physical function).
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
480
Start Date
2026-04-01
Completion Date
2028-03-31
Last Updated
2026-04-28
Healthy Volunteers
No
Interventions
Silkworm pupa tablets
For Experimental arm: Dietary advice + Wanshili Longbao Silkworm Pupa Tablets, 2 tablets each time, 3 times daily, taken half an hour before meals
Placebo
Control arm: Dietary advice + Placebo, 2 tablets each time, 3 times daily, taken half an hour before meals.
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