NCT02174042

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Mar 2014

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 23, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 25, 2014

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

September 11, 2014

Status Verified

September 1, 2014

Enrollment Period

5 months

First QC Date

June 23, 2014

Last Update Submit

September 9, 2014

Conditions

General Disorders and Administration Site Conditions

Outcome Measures

Primary Outcomes (1)

  • The Changing (%) of Blood Glucose Level and Glycosylated Hemoglobin Level from Baseline

    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 Outcomes (1)

  • The Number of Participants with Adverse Events Using Tangning Tongluo Capsule

    At least 3 months

Other Outcomes (1)

  • Number of adverse events in recruited patients.

    At least 3 months

Study Arms (1)

Tangning Tongluo Capsule

EXPERIMENTAL

Type 2 diabetes

Drug: Tangning Tongluo Capsule

Interventions

Tangning Tongluo CapsuleDRUG

Taken drugs 3 times a day, with each time 3 grains

Also known as: TNTL Capsule
Tangning Tongluo Capsule

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nanmeng Tianyuan hospital; Dongfang Hospital; China-Japanese Friendship Hospital

Beijing Shi, Guizhou, 510000, China

Location

Study Officials

  • Wenshu Teng, Dr.

    ICMJE

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 23, 2014

First Posted

June 25, 2014

Study Start

March 1, 2014

Primary Completion

August 1, 2014

Study Completion

September 1, 2014

Last Updated

September 11, 2014

Record last verified: 2014-09

Locations

CN(1)