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NCT02660593 Clinical Trial

Efficacy and Safety ofSanGrow Decoction for Patients With Diabetes

Diabetes Mellitus Clinical Trial

Official title:
SanGrow Decoction in Patients With Diabetes- Single Center, Open, and Non-randomized Study

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02660593
Other study ID # SanGrow Decoction for diabetes
Secondary ID
Status Recruiting
Phase N/A
First received January 17, 2016
Last updated April 26, 2016
Start date March 2016
Est. completion date July 2017

Study information
Verified date January 2016
Source Shidaihuajing Institute for Diabetic Research
Contact Shizhan Chi, PhD
Phone 86-10-53109996
Email chishizhan@lawyee.net
Is FDA regulated No
Health authority China: Beijing Municipal Health Bureau
Study type Interventional

Clinical Trial 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 ]

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 20
Est. completion date July 2017
Est. primary completion date March 2017
Accepts healthy volunteers No
Gender Both
Age group 10 Years to 70 Years
Eligibility 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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• SanGrow Decoction
SanGrow Decoction is perpared according to the principle of Chinese medicine to treat thirsty and maransis.

Locations
Country Name City State
China Jiuhua Hospital Beijing Beijing
China Xuanwu Hospital Beijing Beijing

Sponsors (1)
Lead Sponsor Collaborator
Shidaihuajing Institute for Diabetic Research

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Blood Sugar level Fast glucose change between the baseline and end of study From baseline to 30 and 90 days Yes
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