Ignite Creation Date:
2024-10-25 @ 7:54 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06575478
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-19
Brief Title:
Evaluation of Fuling Yunhua Granules and Dihuang Baoyuan Granules in Drug Naive Type 2 Diabetes Patients
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Evaluation of Fuling Yunhua Granules and Dihuang Baoyuan Granules in Type 2 Diabetes Patients With Poor Blood Glucose Control After Diet and Exercise Intervention a Multi-center Randomized Double-blind Placebo-controlled Clinical Study
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:
The goal of this investigator-initiated clinical trial is to investigate the efficacy and safety of sequential therapy of Fuling Yunhua Granules prescription A and Dihuang Baoyuan Granule prescription B in the treatment of type 2 diabetes patients with poor glycemic control after diet and exercise intervention
Detailed Description:
This is a multicenter randomized double-blind placebo-controlled study including a up to 2-week screening period a 1-week baseline period a 12-week treatment period and a 1-week follow-up period
72 participants who meet the enrollment requirements will enter the baseline period during which 7 days of CGM data will be collected After entering the treatment period participants will be randomly assigned to prescription ABA group prescription ABA-matched placebo group prescription BAB group and prescription BAB-matched placebo group in a ratio of 2121 and receive corresponding treatment
It is expected that an interim analysis will be conducted after 30 participants have completed 4 weeks of treatment and 4 weeks of their data is obtained Based on the CGM data of the participants in the 4th week of treatment the change of TIR in the 4th week compared with the baseline will be analyzed and the IDMC will make a decision based on the results of this analysis
72 participants who meet the enrollment requirements will enter the baseline period during which 7 days of CGM data will be collected After entering the treatment period participants will be randomly assigned to prescription ABA group prescription ABA-matched placebo group prescription BAB group and prescription BAB-matched placebo group in a ratio of 2121 and receive corresponding treatment
It is expected that an interim analysis will be conducted after 30 participants have completed 4 weeks of treatment and 4 weeks of their data is obtained Based on the CGM data of the participants in the 4th week of treatment the change of TIR in the 4th week compared with the baseline will be analyzed and the IDMC will make a decision based on the results of this analysis
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