Ignite Creation Date:
2025-12-24 @ 9:43 PM
Ignite Modification Date:
2026-01-02 @ 1:25 PM
Study NCT ID:
NCT02617732
Status:
UNKNOWN
Last Update Posted:
2015-12-01
First Post:
2015-11-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Tianqi Capsule on Glucose Variability in Patients With Type 2 Diabetes.
Sponsor:
Peking Union Medical College Hospital
Organization:
Study Overview
Official Title:
None
Status:
UNKNOWN
Status Verified Date:
2015-11
Last Known Status:
NOT_YET_RECRUITING
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:
The purpose of this study is to evaluate the effects and safety of Tianqi Capsule on glucose variability in patients with type 2 diabetes by continuous blood glucose monitoring system.
Detailed Description:
Diabetes has become a threat to human health and an independent risk factor to macrovascular and microvascular diseases. Large prospective clinical studies have shown a strong relationship between time-averaged mean levels of glycemia as measured by HbA1c and diabetes complications. However, in recent years several pieces of evidence indicated that glucose variability may also contribute to the development of diabetes complications. Thus, glucose variability may become a new target in treatment of diabetes. Traditional Chinese medicine，a kind of multitargeted compound, may contribute to maintaining blood glucose homeostasis in diabetes.
Tianqi capsule(Chinese herbs extract) is a Chinese patent medicine approved to treat T2DM in China. Previous clinical studies have shown that Tianqi capsule could lower blood glucose measured by HbA1c. What's more, Tianqi capsule has also been proved to improve the glycometabolism and lipid metabolism in T2DM and IGT.
This research adopts a randomized, open, parallel double blind, placebo controlled clinical method. The patients, meeting eligibility criteria, are divided into experimental group and placebo group and treated for 12 weeks . A main outcome，glucose variability is detected by continuous blood glucose monitoring system which could obtain continuous and comprehensive blood glucose by "glucose sensor". The influence of Tianqi capsule on glucose variability in type 2 diabetes will be evaluated.
Tianqi capsule(Chinese herbs extract) is a Chinese patent medicine approved to treat T2DM in China. Previous clinical studies have shown that Tianqi capsule could lower blood glucose measured by HbA1c. What's more, Tianqi capsule has also been proved to improve the glycometabolism and lipid metabolism in T2DM and IGT.
This research adopts a randomized, open, parallel double blind, placebo controlled clinical method. The patients, meeting eligibility criteria, are divided into experimental group and placebo group and treated for 12 weeks . A main outcome，glucose variability is detected by continuous blood glucose monitoring system which could obtain continuous and comprehensive blood glucose by "glucose sensor". The influence of Tianqi capsule on glucose variability in type 2 diabetes will be evaluated.
Study Oversight
Has Oversight DMC:
False
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?: