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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02174042
Recruitment Status : Completed
First Posted : June 25, 2014
Last Update Posted : September 11, 2014
Sponsor:
Information provided by (Responsible Party):
Guizhou Bailing Group Pharmaceutical Co Ltd

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

Condition or disease Intervention/treatment Phase
General Disorders and Administration Site Conditions Drug: Tangning Tongluo Capsule Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Tang Ning Tongluo Formula, a Traditional Chinese Miao Medicine, in Type 2 Diabetics: A Retrospective Clinical Analysis
Study Start Date : March 2014
Actual Primary Completion Date : August 2014
Actual Study Completion Date : September 2014

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 Name: TNTL Capsule




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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


Other Outcome Measures:
  1. Number of adverse events in recruited patients. [ Time Frame: At least 3 months ]
    Number of adverse events in recruited patients.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02174042


Locations
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China, Guizhou
Nanmeng Tianyuan hospital; Dongfang Hospital; China-Japanese Friendship Hospital
Beijing Shi, Guizhou, China, 510000
Sponsors and Collaborators
Guizhou Bailing Group Pharmaceutical Co Ltd
Investigators
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Study Director: Wenshu Teng, Dr. ICMJE

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Responsible Party: Guizhou Bailing Group Pharmaceutical Co Ltd
ClinicalTrials.gov Identifier: NCT02174042    
Other Study ID Numbers: TNTL-14-03
First Posted: June 25, 2014    Key Record Dates
Last Update Posted: September 11, 2014
Last Verified: September 2014