Efficacy and Safety ofSanGrow Decoction for Patients With... | NCT02660593

Studies
Efficacy and Safety ofSanGrow Decoction for Patients With Diabetes

NCT02660593

Sponsor

Shidaihuajing Institute for Diabetic Research

Status

Unknown status

Last Update Posted

Apr 27, 2016Estimated

Enrollment

20Estimated

Phase

Not Applicable

Conditions

Diabetes Mellitus

Interventions

SanGrow Decoction

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2016

Primary Completion Date

Mar 2017Estimated

Completion Date

Jul 2017Estimated

First Submitted Date

Jan 17, 2016

First Submission Date that Met QC Criteria

Jan 20, 2016

First Posted Date

Jan 21, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 26, 2016

Last Update Posted Date

Apr 27, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
SanGrow	Experimental	Patients will be given SanGrow Decoction 150 ml per day for 3 months.	Dietary Supplement: SanGrow Decoction

Interventions

Name	Type	Description	Arm Group Labels	Other Names
SanGrow Decoction	Dietary Supplement	SanGrow Decoction is perpared according to the principle of Chinese medicine to treat thirsty and maransis.	SanGrow

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Blood Sugar level	Fast glucose change between the baseline and end of study	From baseline to 30 and 90 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

10 Years

Maximum Age

70 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Shizhan Chi, PhD	Contact	86-10-53109996	8088	chishizhan@lawyee.net

Overall Officials

Name	Affiliation	Role
Shizhan CHi, PhD	Shidaihuajing Institute	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Jiuhua Hospital	Recruiting	Beijing	Beijing Municipality	100001	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003920	Diabetes Mellitus
D009043	Motor Activity

Ancestor Terms

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided