NCT03167918

Brief Summary

To investigate the protective effect of calcium dobesilate, Xuefuzhuyu Decoction, calcium dobesilate combined with Xuefuzhuyu Decoction on the early lung function of type 2 diabetes mellitus

Trial Health

100
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P50-P75 for phase_2 type-2-diabetes-mellitus

Timeline
Completed

Started Jul 2014

Longer than P75 for phase_2 type-2-diabetes-mellitus

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

July 21, 2014

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

May 15, 2017

Completed
15 days until next milestone

First Posted

Study publicly available on registry

May 30, 2017

Completed
Last Updated

May 30, 2017

Status Verified

May 1, 2017

Enrollment Period

2.7 years

First QC Date

May 15, 2017

Last Update Submit

May 24, 2017

Conditions

Type 2 Diabetes MellitusPulmonary Function

Keywords

calcium dobesilateXuefuzhuyu Decoctionpulmonary function

Outcome Measures

Primary Outcomes (1)

  • Changes in pulmonary function parameters

    The primary endpoints were the between-group differences in the changes in pulmonary function parameters between pretherapy and posttreatment

    26 weeks

Secondary Outcomes (1)

  • Changes in glycosylated hemoglobinA1c, fasting plasma glucose, 2-hour postprandial blood glucose,

    26 weeks

Other Outcomes (2)

  • Changes in blood-fat in Systolic blood pressure,Diastolic blood pressure, and blood-fat

    26 weeks

  • Changes in retrobulbar hemodynamics (RI)

    26 weeks

Study Arms (3)

Calcium dobesilate

EXPERIMENTAL

gave each patient metformin (1000 mg, bid, PO), Mecobalamin Tablets, (0.5 mg bid, PO) and Calcium dobesilate 0.5 g bid, PO

Drug: Calcium DobesilateDrug: metforminDrug: Mecobalamin Tablets

Xuefuzhuyu Decoction

EXPERIMENTAL

gave each patient metformin (1000 mg, bid, PO), Mecobalamin Tablets, (0.5 mg bid, PO) and Xuefuzhuyu Decoction 100 ml bid，po

Drug: Xuefuzhuyu DecoctionDrug: metforminDrug: Mecobalamin Tablets

Xuefuzhuyu Decoction &Calcium dobesilate

EXPERIMENTAL

gave each patient metformin (1000 mg, bid, PO), Mecobalamin Tablets, (0.5 mg bid, PO) and Calcium dobesilate (0.5 g bid, PO)\& Xuefuzhuyu Decoction（100 ml bid，po)

Drug: Xuefuzhuyu Decoction & Calcium dobesilateDrug: metforminDrug: Mecobalamin Tablets

Interventions

Calcium DobesilateDRUG

gave each patient 0.5 g bid，

Calcium dobesilate
Xuefuzhuyu DecoctionDRUG

gave each patient100 ml bid，po

Xuefuzhuyu Decoction
Xuefuzhuyu Decoction & Calcium dobesilateDRUG

gave each patient Calcium dobesilate 0.5 g bid，po and Xuefuzhuyu Decoction 100 ml bid，po

Xuefuzhuyu Decoction &Calcium dobesilate
metforminDRUG

gave each patient 1000 mg, bid, PO

Calcium dobesilateXuefuzhuyu DecoctionXuefuzhuyu Decoction &Calcium dobesilate
Mecobalamin TabletsDRUG

gave each patient 0.5 mg bid, PO

Calcium dobesilateXuefuzhuyu DecoctionXuefuzhuyu Decoction &Calcium dobesilate

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • patients who were diagnosed with type 2 diabetes mellitus according to the guidelines of the American Diabetes Association ;
  • had no history of smoking, pulmonary disease, cold, or pulmonary infection within a two-week period;
  • were not diagnosed with hepatopathy, nephropathy, hyperuricemia, or gastrointestinal disease;
  • were likely to have good compliance and were able to visit our hospital for periodic assessments.

You may not qualify if:

  • , type 1 diabetes, pregnant women;
  • there are important organ dysfunction;
  • the need to control blood glucose after insulin injection (poor drug control);
  • the life of patients with irregular or serious addiction (alcoholism),
  • poor compliance and compliance;
  • the experiment of drug intolerance (severe allergic reaction 6);
  • hypertension and hyperuricemia;
  • and nearly two weeks colds, pneumonia and other respiratory diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Calcium DobesilateMetforminmecobalamin

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

BenzenesulfonatesBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsArylsulfonatesArylsulfonic AcidsSulfonic AcidsSulfur AcidsSulfur CompoundsBiguanidesGuanidinesAmidines

Study Officials

  • Xiao-lin Jiang

    Liaoning University of Traditional Chinese Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

May 15, 2017

First Posted

May 30, 2017

Study Start

July 21, 2014

Primary Completion

April 1, 2017

Study Completion

May 1, 2017

Last Updated

May 30, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share