Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06450652
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-10
First Post:
2024-06-05
Brief Title:
CHM for T2DM MetS
Sponsor:
Hong Kong Baptist University
Organization:
Hong Kong Baptist University
Study Overview
Official Title:
Feasibility Safety and Effectiveness of Chinese Herbal Medicine for T2DM Patients With Comorbid Metabolic Syndrome A Single-arm Pilot Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a single-arm design A total of 15 Type 2 Diabetes Mellitus T2DM patients with comorbid Metabolic Syndrome MetS will be recruited from community The intervention will be a 4-week of Chinese Herbal Medicine granules treatment which will consist of six Chinese herbs The primary outcome measure will be fasting plasma glucose and blood pressure Secondary outcome measures including changes of anthropometric data body mass index waist-to-hip ratio lipid panels total cholesterol triglycerides high-density lipoprotein low-density lipoprotein HbA1C Framingham Stroke Risk Score FSRS Audit of diabetes-dependent quality of Life ADDQoL International Physical Activity Questionnaire Short Form IPAQ-SF daily step count and physiological parameters from wearable watch dietary record retinal and sublingual vein imaging concurrent medications and adverse events
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None