Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06551675
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-06
Brief Title:
Effect of Silkworm Pupa Tablets in Gastrointestinal Malignancies at Nutritional Risk Following Radical Surgery
Sponsor:
None
Organization:
None
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
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 Study population malignant gastrointestinal tumors including gastric cancer colorectal cancer esophageal cancer and pancreatic cancer and has undergone radical surgical resection If necessary perioperative systemic treatment has been completed by the time of screening and has a nutritional risk score of 3 based on the NRS 2002 nutritional risk screening tool
2 Sample size totally 120 cases including 60 cases in the experimental group and 60 cases in the control group
3 Research content In this study participants will begin taking the trial product or control immediately upon enrollment with a treatment duration of 3 monthsExperimental Group Wanshililongbao silkworm pupa tablets Control Group contains 05 of the active ingredient of the trial product indistinguishable in appearance
1 Study population malignant gastrointestinal tumors including gastric cancer colorectal cancer esophageal cancer and pancreatic cancer and has undergone radical surgical resection If necessary perioperative systemic treatment has been completed by the time of screening and has a nutritional risk score of 3 based on the NRS 2002 nutritional risk screening tool
2 Sample size totally 120 cases including 60 cases in the experimental group and 60 cases in the control group
3 Research content In this study participants will begin taking the trial product or control immediately upon enrollment with a treatment duration of 3 monthsExperimental Group Wanshililongbao silkworm pupa tablets Control Group contains 05 of the active ingredient of the trial product indistinguishable in appearance
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None