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

NCT ID: NCT02039544

Last Updated: 2014-01-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2015-05-31

Brief Summary

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)

Detailed 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.

Conditions

Diabetic Peripheral Neuropathy; Diabetes; Chinese Herbs

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Xuebi formula

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

Group Type: EXPERIMENTAL

Xuebi formula

Intervention Type: DRUG

Placebo

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

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

Interventions

Xuebi formula

Intervention Type: DRUG

placebo

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Fengmei Lian

chair

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xiaolin Tong, PHD

Role: STUDY_CHAIR

Guang'anmen Hospital

Central Contacts

qiang zhou, PHD

Role: CONTACT

15101016416@126.com

15101016416 ext. 0086

Other Identifiers

20131205

Identifier Type: -

Identifier Source: org_study_id