Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06393413
Status:
COMPLETED
Last Update Posted:
2024-05-02
First Post:
2024-04-25
Brief Title:
To Explore the Therapeutic Potential of Jiedu Yizhi Formula for Alzheimer s Disease
Sponsor:
Changchun University of Chinese Medicine
Organization:
Changchun University of Chinese Medicine
Study Overview
Official Title:
Changchun University of Chinese Medicine
Status:
COMPLETED
Status Verified Date:
2024-04
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:
AD patients who met the inclusion criteria in the encephalopathy clinic and treatment area of the Third Clinical Hospital Affiliated to Changchun University of Traditional Chinese Medicine from December 2022 to December 2023 were collected and randomly divided into traditional Chinese medicine experimental group and western medicine control group The experimental group was treated with Jiedu Yizhi Formula and the control group was treated with Donepezil Hydrochloride Tablets trade name Aricept The two groups were given AD cognitive behavior training and health education at the same time The course of treatment was 24 weeks The Western medicine scale was measured before treatment 12 weeks after treatment and 24 weeks after treatment to evaluate the effect of drugs on cognitive function and daily living ability
Detailed Description:
From December 2022 to December 2023 we conducted a prospective randomized controlled single center study on AD patients exhibiting mild to moderate spleen and kidney deficiency phlegm turbidity and obstruction of the orifices These patients were admitted to the outpatient department and treatment area of the Brain Disease Department at the Third Affiliated Clinical Hospital of Changchun University of Chinese Medicine Following a comprehensive evaluation the diagnosis of AD was confirmed This study was conducted in accordance with the principles of the Helsinki Declaration The practitioner declares that all procedures follow medical regulations and this study was evaluated and approved by the Ethics Committee of the Third Affiliated Clinical Hospital of Changchun University of Traditional Chinese Medicine The study was designed based on the observation reports presented in the randomized controlled study of strengthening epidemiology STROBEThe traditional Chinese medicine treatment group received modified Jiedu Yizhi Formula therapy with no more than 3 flavors customized based on syndrome differentiation The herbal composition included 10g of Coptis chinensis Franch Huanglian Ranunculaceae rhizome 20g of Alpinia oxyphylla MiqYizhiren Zingiberaceae fructus 10g of Chinemys reevesiiGuibanjiao 10g of Rheum webbianum Jiu Dahuang rhizome 10g of Cornus officinalis Shanzhuyu Cornaceae fructus 10g of Pheretima aspergillum Dilong and 10g of Oreocome striata Chuanxiong Apiaceae rhizome 300ml of water decoction juice was prepared from each pair of herbs and 100ml was taken daily after breakfast and dinner The Western medicine control group on the other hand was administered donepezil hydrochloride Anlishen 5mgtablet from Weicai China Pharmaceutical Co Ltd orally before bedtime at a dosage of 5mg per day Subsequently the dosage was increased to 10mg per day for maintenance therapy leading to a total of 24 weeks of continuous treatment Additionally both patient groups were provided guidance on actively addressing and managing various risk factors associated with Alzheimers disease in conjunction with cognitive behavioral training
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