Efficacy and Safety ofSanGrow Decoction for Patients With Diabetes

NCT ID: NCT02660593

Last Updated: 2016-04-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2017-07-31

Brief Summary

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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

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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.

Conditions

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Diabetes Mellitus

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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SanGrow

Patients will be given SanGrow Decoction 150 ml per day for 3 months.

Group Type EXPERIMENTAL

SanGrow Decoction

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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SanGrow Decoction

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Minimum Eligible Age

10 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shidaihuajing Institute for Diabetic Research

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Shizhan CHi, PhD

Role: STUDY_CHAIR

Shidaihuajing Institute

Locations

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Jiuhua Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Xuanwu Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Shizhan Chi, PhD

Role: CONTACT

86-10-53109996 ext. 8088

Facility Contacts

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Chi Shizhan, Master

Role: primary

Chi Shizhan, Master

Role: primary

Other Identifiers

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SanGrow Decoction for diabetes

Identifier Type: -

Identifier Source: org_study_id

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