NCT02660593UnknownNot Applicable
SanGrow Decoction in Patients With Diabetes- Single Center, Open, and Non-randomized Study
Shidaihuajing Institute for Diabetic Research2 sites in 1 country20 target enrollmentStarted: March 1, 2016Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 20
- Locations
- 2
- Primary Endpoint
- Blood Sugar level
Study Overview
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 ]
Detailed Description
This study is aimed to evaluate the safety and efficacy of Sangrow Decotion, diet and exercise for the treatment of type 2 diabetes. Previous study has shown that this therapeutic regimen is safe and effective.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 10 Years to 70 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Type II diabetes mellitus patients who have received medical treatment for more than 3 months
- •Patients willing to sign written informed consent form
Exclusion Criteria
- •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.
Arms & Interventions
SanGrow
Experimental
Patients will be given SanGrow Decoction 150 ml per day for 3 months.
Intervention: SanGrow Decoction (Dietary Supplement)
Outcomes
Primary Outcomes
Blood Sugar level
Time Frame: From baseline to 30 and 90 days
Fast glucose change between the baseline and end of study
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (2)
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