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Efficacy and Safety ofSanGrow Decoction for Patients With Diabetes

S

Shidaihuajing Institute for Diabetic Research

Status

Unknown

Conditions

Diabetes Mellitus

Treatments

Dietary Supplement: SanGrow Decoction

Study type

Interventional

Funder types

Other

Identifiers

NCT02660593
SanGrow Decoction for diabetes

Details and patient eligibility

About

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 ]

Full 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.

Enrollment

20 estimated patients

Sex

All

Ages

10 to 70 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

20 participants in 1 patient group

SanGrow
Experimental group
Description:
Patients will be given SanGrow Decoction 150 ml per day for 3 months.
Treatment:
Dietary Supplement: SanGrow Decoction

Trial contacts and locations

2

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Central trial contact

Shizhan Chi, PhD

Data sourced from clinicaltrials.gov

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