Ignite Creation Date:
2024-05-06 @ 3:56 PM
Last Modification Date:
2024-10-26 @ 2:00 PM
Study NCT ID:
NCT04812236
Status:
UNKNOWN
Last Update Posted:
2021-03-23
First Post:
2021-02-22
Brief Title:
Clinical Study on Wuling Powder in Treating Metabolic Syndrome of Spleen Deficiency and Dampness
Sponsor:
Jiangsu Famous Medical Technology Co Ltd
Organization:
Jiangsu Famous Medical Technology Co Ltd
Study Overview
Official Title:
A Randomized Partially Double-blind Controlled Multi-center Clinical Study of Wulingsan Single Decoction Granules Combined With Conventional Therapy in the Treatment of Metabolic Syndrome of Spleen Deficiency Dampness and Sleepiness
Status:
UNKNOWN
Status Verified Date:
2021-01
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:
In this study a randomized partially double-blind controlled multi-center clinical research method was used A total of 4 groups were designed namely single decoction group co-decoction group powder group and simulation group The four groups of patients all received basic health education diet control and increased exercise guidance All the patients in the group have taken western medicine according to their own conditions and followed the doctors instructions for hypoglycemic blood pressure and lipid-lowering treatments After joining the group they continue to take the medicine at the original dose and the patients are advised not to change the medicine during the observation period Take 12 weeks as a course of treatment and set the observation period to 12 weeks Follow up every 4 weeks
Detailed Description:
The research purpose of this project is to observe the effectiveness and safety of Wulingsan single decoction granules compared with traditional powder co-decoction granules and analogues in the treatment of metabolic syndrome in combination with conventional therapies Compared with Wulingsan traditional powder and co-decoction granule group observe the effectiveness and safety of traditional powder combined with conventional therapy in the treatment of metabolic syndrome The trial adopts a randomized partially double-blind controlled multi-center clinical research method A total of 320 cases were included in 4 groups namely single decoction group co-decoction group powder group and simulated agent group The four groups of patients all received basic health education diet control and increased exercise guidance All the patients in the group have taken western medicine according to their own conditions and followed the doctors instructions for hypoglycemic blood pressure and lipid-lowering treatments After joining the group they continue to take the medicine at the original dose and the patients are advised not to change the medicine during the observation period Take 12 weeks as a course of treatment and the observation period is set to 12 weeks Follow up every 4 weeks
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