Berberine treat different curative effect observation of TCM syndrome type 2 diabetes

• Register: ChiCTR
• Last refreshed on: 18 April 2017
• Main ID: ChiCTR-INR-16009989
• Date of registration: 2017-02-01
• Prospective Registration: No
• Primary sponsor: Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
• Public title: Berberine treat different curative effect observation of TCM syndrome type 2 diabetes
• Scientific title: Berberine treat different curative effect observation of TCM syndrome type 2 diabetes
• Date of first enrolment: 2016-12-01
• Target sample size: Yin deficiency group hotness:48;Hot and humid trapped spleen group:48;Qi and Yin two virtual group:48;Qi deficiency and blood stasis group:48;
• Recruitment status: Pending
• URL: http://www.chictr.org.cn/showproj.aspx?proj=16973
• Study type: Interventional study
• Study design: Randomized parallel controlled trial
• Phase: New Treatment Measure Clinical Study

Countries of recruitment

China

Contacts

• Name: Yang Hua
• Affiliation: Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine

• Name: Yang Hua
• Affiliation: Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine

Key inclusion & exclusion criteria

Inclusion criteria: 1. Meet the western medicine diagnosis and syndrome differentiation of traditional Chinese medicine diagnosis and classification standards;
2. Aged between 18 to 75 years (including 18 years old, 75 years old), male and female;
3. After treatment with diet, exercise and oral glucose-lowering drugs poor glycemic control: 8 tendency/L < 15 tendency for L, fasting glucose or less tendency for 10 L < blood sugar 2 hours after meals < 20 tendency/L, and 8.0% or less hemoglobin a1c < 12 tendency for L. And use the original hypoglycemic regimen for more than 4 weeks;
4. Have informed consent and can cooperate with the visitor on schedule.
Exclusion criteria: 1. Pregnancy or breast-feeding women and may this medicine allergy;
2. Reluctant to partners (can't cooperate with diet control or does not affect curative effect in accordance with the provisions, medication);
3. Patients have been treated with berberine;
4. Mental illness, or with other serious primary diseases.
Nearly a month with diabetic ketoacidosis, hypertonic coma acute metabolic disorders.

Age minimum: 18
Age maximum: 75
Gender: Both

Health Condition(s) or Problem(s) studied

diabetes

Intervention(s)

Yin deficiency group hotness:On the basis of the original scheme combined with berberine, three times a day, each 0.3 ~ 0.3 g.;Hot and humid trapped spleen group:On the basis of the original scheme combined with berberine, three times a day, each 0.3 ~ 0.3 g.;Qi and Yin two virtual group:On the basis of the original scheme combined with berberine, three times a day, each 0.3 ~ 0.3 g.;Qi deficiency and blood stasis group:On the basis of the original scheme combined with berberine, three times a day, each 0.3 ~ 0.3 g.;

Primary Outcome(s)

Venous blood sugar on an empty stomach;Venous blood sugar 2 hours after breakfast;Glycated hemoglobin;

Source(s) of Monetary Support

Shanghai shen-kang hospital development center