Efficacy and Safety ofSanGrow Decoction for Patients With Diabetes
SanGrow Decoction in Patients With Diabetes- Single Center, Open, and Non-randomized Study
1 other identifier
interventional
20
1 country
2
Brief Summary
MedlinePlus related topics: Blood Sugar Primary Outcome Measures:
- Fast glucose and HbA1c change between the baseline and end of study \[ Time Frame: From baseline to 30 and 100 days\]
- \[ Designated as safety issue: No \]
- Successful rate of blood glucose control (the proportion of patients with HbA1c \<7%) \[ Time Frame: From baseline to 30 days and 100 days\] \[ Designated as safety issue: No \] Secondary Outcome Measures:
- To evaluate the change of quality of life in the 1 months by the health questionnaire SF-36 \[ Time Frame: From baseline to month 1 \] \[ Designated as safety issue: No \]
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable diabetes-mellitus
Started Mar 2016
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 17, 2016
CompletedFirst Posted
Study publicly available on registry
January 21, 2016
CompletedStudy Start
First participant enrolled
March 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2017
CompletedApril 27, 2016
January 1, 2016
1 year
January 17, 2016
April 26, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Blood Sugar level
Fast glucose change between the baseline and end of study
From baseline to 30 and 90 days
Study Arms (1)
SanGrow
EXPERIMENTALPatients will be given SanGrow Decoction 150 ml per day for 3 months.
Interventions
SanGrow Decoction is perpared according to the principle of Chinese medicine to treat thirsty and maransis.
Eligibility Criteria
You may qualify if:
- Type II diabetes mellitus patients who have received medical treatment for more than 3 months
- Patients willing to sign written informed consent form
You may not qualify if:
- Patients unable or unwilling to comply with the requirements of the protocol
- Females who are pregnant or nursing or females of childbearing potential who are unwilling to maintain contraceptive therapy for the duration of the study
- Life expectancy \< 6 months due to concomitant illnesses.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Jiuhua Hospital
Beijing, Beijing Municipality, 100001, China
Xuanwu Hospital
Beijing, Beijing Municipality, 100001, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Shizhan CHi, PhD
Shidaihuajing Institute
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 17, 2016
First Posted
January 21, 2016
Study Start
March 1, 2016
Primary Completion
March 1, 2017
Study Completion
July 1, 2017
Last Updated
April 27, 2016
Record last verified: 2016-01
Data Sharing
- IPD Sharing
- Will not share