Research on the comprehensive therapy for impaired glucose tolerance (IGT) by traditional Chinese medicine

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN90063632

Enrollment

2000

Registered

2008-07-10

Start date

2008-03-01

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 diabetes/ cardiovascular diseases Nutritional, Metabolic, Endocrine Non-insulin-dependent diabetes mellitus

Interventions

1. Traditional Chinese medicine Tian-qi Jiang-tang Capsule™, 5 capsules three times a day, combined with lifestyle interventions 2. Placebo combined with lifestyle interventions Lifestyle intervent

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Both males and females 2. 25 ==7.8 mmol/L 4. Deficiency of both qi and yin syndromes accompanied by heat 5. Taking no medicine for treatment of IGT 6. 18.5 kg/m2 < body mass index (BMI) <30 kg/m2 7. Voluntariness, and signed letter of consent 8. Those who do not take part in any other trails within 3 months

Exclusion criteria

Exclusion criteria: 1. Acute cardiovascular disease and myocardial infarction within 6 months 2. Proliferative retinopathy that needs to be treated by laser 3. Not compliant 4. Mental disease 5. Pregnant or lactating women; women without contraception 6. Allergic to any traditional chinese medicine 7. Co-morbid with other endocrine disease or serious protopathy 8. Systolic blood pressure (SBP) >= 160 mmHg, diastolic blood pressure (DBP) >= 100 mmHg and secondary hypertension 9. Cholesterol (CHO) >= 6.22 mmol/L(240 mg/dl) or low density lipoprotein (LDL) >= 4.14 mmol/L (160 mg/dl) 10. Patients who are treated by other hypoglycemic drug

Design outcomes

Primary

Measure	Time frame
Blood glucose (FPG and 2hPG of OGTT) at baseline, and every 3 months during intervention (3 years) and follow-up (6 months).	—

Secondary

Measure	Time frame
Risk of cardiovascular disease, assessed by the following: 1. Blood lipid, assessed at baseline, 6, 12, 18, 24, 30 and 36 months 2. Blood pressure, measured at baseline and then every 3 months during the intervention (3 years) and follow-up (6 months) 3. BMI, measured every 3 months during the intervention (3 years) and follow-up (6 months) 4. Electrocardiogram (ECG), carried out every 6 months during the intervention (3 years) The following will be assessed in a sub-group of approximately 500 participants: 1. HbA1c, assessed every 6 months during the intervention (3 years) 2. Urinary albumin excretion rate (UAER), assessed at baseline, at 3, 6, 12 and 36 months 3. High-sensitivity C-reactive protein (hs-CRP) baseline, 12 and 36 months 4. Adiponection, baseline, 12 and 36 months 5. OGTT: 5.1. At baseline (0 hour), assessed at baseline and every 3 month during the intervention (3 years) and follow-up (6 months) 5.2. 0.5 hours, assessed at baseline, 6, 12, 24 and 36 months 5.3. 1 hour, assessed at baseline, 12 and 36 months 5.4. 2 hours, assessed at baseline and then every 3 months during the intervention (3 years) and follow-up (6 months) 6. Insulin level: 6.1. Baseline insulin level, measured at baseline (0 month) and every three months until 12 months, and then 24 and 36 months 6.2. Insulin level at 0.5 hours, measured at baseline (0 month) and every three months until 12 months, and then 24 and 36 months 6.3. Insulin level at 1 hour, measured at baseline (0 month), 12 and 36 months 6.4. Insulin level at 2 hours, measured at baseline, every three months until 12 months, and then 24 and 36 months Note: We will choose the participants who will likely to be compliant for the sub-group study.	—

Measure

Time frame

Risk of cardiovascular disease, assessed by the following: 1. Blood lipid, assessed at baseline, 6, 12, 18, 24, 30 and 36 months 2. Blood pressure, measured at baseline and then every 3 months during the intervention (3 years) and follow-up (6 months) 3. BMI, measured every 3 months during the intervention (3 years) and follow-up (6 months) 4. Electrocardiogram (ECG), carried out every 6 months during the intervention (3 years) The following will be assessed in a sub-group of approximately 500 participants: 1. HbA1c, assessed every 6 months during the intervention (3 years) 2. Urinary albumin excretion rate (UAER), assessed at baseline, at 3, 6, 12 and 36 months 3. High-sensitivity C-reactive protein (hs-CRP) baseline, 12 and 36 months 4. Adiponection, baseline, 12 and 36 months 5. OGTT: 5.1. At baseline (0 hour), assessed at baseline and every 3 month during the intervention (3 years) and follow-up (6 months) 5.2. 0.5 hours, assessed at baseline, 6, 12, 24 and 36 months 5.3. 1 hour, assessed at baseline, 12 and 36 months 5.4. 2 hours, assessed at baseline and then every 3 months during the intervention (3 years) and follow-up (6 months) 6. Insulin level: 6.1. Baseline insulin level, measured at baseline (0 month) and every three months until 12 months, and then 24 and 36 months 6.2. Insulin level at 0.5 hours, measured at baseline (0 month) and every three months until 12 months, and then 24 and 36 months 6.3. Insulin level at 1 hour, measured at baseline (0 month), 12 and 36 months 6.4. Insulin level at 2 hours, measured at baseline, every three months until 12 months, and then 24 and 36 months Note: We will choose the participants who will likely to be compliant for the sub-group study.

—

Countries

China

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026