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Intervention strategy of Traditional Chinese Medicine for prediabetes(the syndrome of spleen-deficiency phlegm-dampness) based on the reversal of blood glucose and the improvement of fatigue

Phase 1
Conditions
Prediabetes
Registration Number
ITMCTR1900002298
Lead Sponsor
Tianjin University of Traditional Chinese Medicine
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
All
Target Recruitment
Not specified
Inclusion Criteria

(1) Patients who meet the diagnostic criteria for the prediabetes with the syndrome of spleen-deficiency phlegm-dampness;
(2) Patients with moderate or severe fatigue were included evaluated by the self-rating scale;
(3) Aged 30 to 75 years old;
(4) No participating in clinical studies of other interventions within 2 weeks before inclusion;
(5) Participating in and signing the informed consent voluntarily.

Exclusion Criteria

(1) The history of diabetes (except gestational diabetes);
(2) Recent cardiovascular events, mental disease, and severe hepatic and renal insufficiency;
(3) Hyperthyroidism and other endocrine diseases;
(4) Taking glucocorticoid, ßreceptor blockers, thiazide diuretics, niacin and other drugs;
(5) Pregnant and lactating women;
(6) Participanting in clinical trials of other drugs recently.

Study & Design

Study Type
Interventional study
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
the score of FS-14 scale;the rate of glycemic reversion;
Secondary Outcome Measures
NameTimeMethod
aboratory index;Safety index;
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