Efficacy and Safety ofSanGrow Decoction for Patients With Diabetes

April 26, 2016 updated by: Shidaihuajing Institute for Diabetic Research

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

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 ]

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100001
        • Recruiting
        • Jiuhua Hospital
        • Contact:
          • Chi Shizhan, Master
      • Beijing, Beijing, China, 100001
        • Recruiting
        • Xuanwu Hospital
        • Contact:
          • Chi Shizhan, Master

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 70 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SanGrow
Patients will be given SanGrow Decoction 150 ml per day for 3 months.
Dietary supplement: SanGrow Decoction
SanGrow Decoction is perpared according to the principle of Chinese medicine to treat thirsty and maransis.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shidaihuajing Institute for Diabetic Research

Investigators

  • Study Chair: Shizhan CHi, PhD, Shidaihuajing Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2016

Primary Completion (Anticipated)

March 1, 2017

Study Completion (Anticipated)

July 1, 2017

Study Registration Dates

First Submitted

January 17, 2016

First Submitted That Met QC Criteria

January 20, 2016

First Posted (Estimate)

January 21, 2016

Study Record Updates

Last Update Posted (Estimate)

April 27, 2016

Last Update Submitted That Met QC Criteria

April 26, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SanGrow Decoction for diabetes

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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