A Study of Xuebi Formula for Diabetic Peripheral Neuropathy(Qi-deficiency and Blood-stasis) (XB)

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Status: Unknown

Conditions: Chinese Herbs; Diabetes; Diabetic Peripheral Neuropathy

Treatments: Drug: placebo; Drug: Xuebi formula

Study type: Interventional

Funder types: Other

Identifiers

NCT02039544

20131205

Details and patient eligibility

About

A Randomized, Parallel-controlled, Clinical Study to Evaluate the Efficacy of Xuebi Prescription Compared With Placebo in the Treatment of Diabetic Peripheral Neuropathy(Qi Deficiency and Blood Stasis)

Full description

Charged by the sponsor in line with traditional Chinese medicine Qi deficiency and blood stasis syndrome 60 cases have DPN，they were randomly divided into Chinese herbal compound Xuebi prescription group and placebo group. The treatment groups were compared 24-week composite score.

Enrollment: 60 estimated patients

Sex: All

Ages: 30 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

• according to the 1999 WHO criteria, in accordance with the diagnostic criteria for type 2 diabetes.
• according to the diagnostic standard of diabetes peripheral nerve lesions.
• age range 30-70 years.
• Syndrome of traditional Chinese medicine is Qi deficiency and blood stasis.
• FBG < 13.9mmol/L, HbA1c<10%.
• signed the informed consent

Exclusion Criteria:

• did not meet the inclusion criteria, or incomplete information affect the clinical syndrome differentiation type;
• repeated hypoglycemia reaction, nearly a month diabetic ketoacidosis, DKAand severe infections;
• blood pressure without control or after control, SBP ≥ 160mmHg or (and)DBP ≥ 100mmHg;
• TG≥ 5.6mmol / L;
• diabetic lower extremity vascular disease (resting ankle brachial index in patients with ABI ≤ 0.90 or lower extremity ultrasound vascular stenosis > 50%).
• pregnancy, to pregnant or lactating women;
• the ingredients allergy of Chinese herbal medicine and allergic constitution person;
• psychiatric patients;
• have serious heart, lung, liver, kidney, brain and other complications overassociated with other severe primary diseases;
• other patients had participated in clinical trials or are in other clinical trials before the test in January;
• in the past 5 years with alcohol and / or psychoactive substances, drug abuse and dependence;
• according to the researcher's judgment, can reduce the possibility of the group or other diseases or conditions were complicated, such as work environment change frequently, the living environment is not stable, easy to cause lost
• hepatic, renal impairment (ALT, AST is greater than 2.5 times the upper limit of normal value; serum creatinine greater than 1.5 times the upper limit of normal value);
• demyelinating lesions or from other causes of polyneuropathy patients.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups, including a placebo group

Xuebi formula

Experimental group

Description:

Xuebi formula , one dosage ,every day, treat 6 months.

Treatment:

Drug: Xuebi formula

Placebo

Placebo Comparator group

Description:

placebo,has the same taste and color as Xuebi formula one dosage ,every day, treat 6 months.

Treatment:

Drug: placebo