Traditional Chinese Medicine in Individualized Treatment of Patients With Diabetes Symptoms

NCT ID: NCT01844050

Last Updated: 2019-06-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2009-10-31

Brief Summary

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Based on the Individualized treatment of diabetes symptoms to evaluate the method of syndrome differentiation treatment of Traditional Chinese medicine.

Detailed Description

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Conditions

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Type 2 Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Chinese herbal medicine

Individualized Treatment with Chinese herbal

Group Type EXPERIMENTAL

Chinese herbal medicine

Intervention Type DRUG

According to the traditional Chinese medicine syndrome of subject to make up a prescription within the 35 kinds of chosen Chinese herbal medicine, and the dosage without limitation.

Placebo

Individualized Treatment with placebo Chinese herbal which Containing 2% of Chinese herbal medicine.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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Chinese herbal medicine

According to the traditional Chinese medicine syndrome of subject to make up a prescription within the 35 kinds of chosen Chinese herbal medicine, and the dosage without limitation.

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Newly diagnosed type 2 diabetes poorly controlled by diet and exercise therapy, and must with any of diabetes symptoms.
* After the diet and exercise therapy, 7.0mmol/l≤FPG≤11.1mmol/l or 8.0mmol/l\<2h PG\<16mmol/l
* Any type of TCM syndrome, but can be performed within the chosen Chinese herbal medicine.
* Subject is willing to participate and capable of giving informed consent.

Exclusion Criteria

* Those patients used any drugs for treatment of diabetes within one month.
* Patients with any severe complications of cardiac, cerebric, vascular, hepatic, renal, blood system.
* Patients suffer from acute metabolic disorder including diabetic ketoacidosis or hyperosmotic non-ketotic coma within one month.
* Women who were pregnant, lactating or planned pregnant.
* Allergic constitution and has a history of drug allergy.
* Combined with severe acute or chronic infections.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Longhua Hospital

OTHER

Sponsor Role collaborator

Shanghai Putuo District Center Hospital

OTHER

Sponsor Role collaborator

Shanghai University of Traditional Chinese Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kaixian Chen, Ph.D

Role: STUDY_CHAIR

Shanghai Universitu of TCM

Locations

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Shanghai University of Traditional Chinese Medicine

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Other Identifiers

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S06DZ19728

Identifier Type: OTHER

Identifier Source: secondary_id

06DZ19728-2

Identifier Type: -

Identifier Source: org_study_id

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