The Effect of Tang Ning Tongluo Formula in Type 2 Diabetics Clinical Analysis

September 9, 2014 updated by: Guizhou Bailing Group Pharmaceutical Co Ltd

The Effect of Tang Ning Tongluo Formula, a Traditional Chinese Miao Medicine, in Type 2 Diabetics: A Retrospective Clinical Analysis

The aim of this retrospective study is to review and describe safety and efficacy of Tang Ning Tong Luo capsule.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The aim of this retrospective study is to review and describe safety and efficacy of Tang Ning Tong Luo capsule,a traditional Chinese Miao medicine, in Type 2 Diabetics.

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Phase 2

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
    • Guizhou
      • Beijing Shi, Guizhou, China, 510000
        • Nanmeng Tianyuan hospital; Dongfang Hospital; China-Japanese Friendship Hospital

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

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  1. diagnosis of type 2 diabetes for more than one year.
  2. the sustained follow-up time >3 month.
  3. TNTL single or combined treatment time >3 month.
  4. Chinese ethnicity.

Exclusion criteria:

  1. the medical record information is not original and available.
  2. lactating or pregnant.
  3. diagnosis of heart failure, acute myocardial infarction, stroke, or serious injuries.
  4. any other conditions not suitable for trial as evaluated by the physician in charge.

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: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Tangning Tongluo Capsule
Type 2 diabetes
Drug: Tangning Tongluo Capsule
Taken drugs 3 times a day, with each time 3 grains
Other Names:
  • TNTL Capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Changing (%) of Blood Glucose Level and Glycosylated Hemoglobin Level from Baseline
Time Frame: At least 3 months
The Changing (%) of Blood Glucose Level (mmol/L) and Glycosylated Hemoglobin Level (%) from Baseline (start using Tang Ning Tong Luo capsule) in recruited Type 2 diabetes patients.
At least 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Number of Participants with Adverse Events Using Tangning Tongluo Capsule
Time Frame: At least 3 months
The Number of Participants with Adverse Events Using Tangning Tongluo Capsule in the Treatment ofType II Diabetes
At least 3 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of adverse events in recruited patients.
Time Frame: At least 3 months
Number of adverse events in recruited patients.
At least 3 months

Collaborators and Investigators

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

Sponsor

Guizhou Bailing Group Pharmaceutical Co Ltd

Investigators

  • Study Director: Wenshu Teng, Dr., ICMJE

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, 2014

Primary Completion (ACTUAL)

August 1, 2014

Study Completion (ACTUAL)

September 1, 2014

Study Registration Dates

First Submitted

June 23, 2014

First Submitted That Met QC Criteria

June 24, 2014

First Posted (ESTIMATE)

June 25, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

September 11, 2014

Last Update Submitted That Met QC Criteria

September 9, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

  • TNTL-14-03

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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