Metabolic Syndrome
Conditions
Interventions
Test group:linggui zhugan Traditional Chinese Medicinal Granules
control goup:linggui zhugan decoction pieces
Sponsors
Xiyuan Hospital of China Academy of Chinese Medicine Sciences
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) cases meet the Metabolic Syndrome diagnosis standards; (2) cases meet the TCM syndrome of dampness due to spleen deficiency; (3) cases corresponding to Metabolic Syndrome diagnosis standards both in enrollment and 4 weeks after lifestyle modification; (4) FBG=6.1mmol/L(ll0mg/dl) and/or hyperglycemia has been diagnosed; (5) Aged between 18~65 years old; (6) ICF has been signed.
Exclusion criteria
Exclusion criteria: (1) Hyperglycemia with FBG=7mmol/L(126mg/dL) or HA1C=8% after lifestyle modification and medication; (2) TC=6.22mmol/L(240mg/dL) or LDL-C=4.92mmol/L(190mg/dL) or TG=3.39mmol/L(300mg/dL); (3) SBP=160mmHg and/or DBP=100mmHg; (4) Cases of malignant cancer,severe cardiovascular diseases,hematological diseases,cerebrovascular diseases,severe trauma or post major surgeries; (5) Cases of nephrotic syndrome,hypothyroidism,acute/chronic liver & gallbladder diseases or gout; (6) Dyslipidemia induced by drugs(such as phenothiazines,ß-receptor-blocker,adrenal corticosteroids); (7) Abnormality of liver or kidney function(ALT>1.5N or Cr>N(N represents upper limit of normal)); (8) Allergic constitution or be allergic to test medications; (9) Abuse of drugs or alcohol; (10) Active liver diseases or mental illness; (11) Be in other clinical trials in recent three months; (12) Pregnancy, prepare to pregnant or in lactation; (13) Any other unfit conditions judged by investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HOMA-IR;FPG;MS sydrome related indicators;TCM symptoms disappearance rate; | — |
Countries
China
Contacts
Public ContactRui Gao
Xiyuan Hospital of China Academy of Chinese Medical Sciences
Outcome results
None listed