Clinical trial NCT02039544: A Study of Xuebi Formula for Diabetic Peripheral Neuropathy(Qi-deficiency and Blood-stasis)
Official title: 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)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetic Peripheral Neuropathy
Diabetes
Chinese Herbs
Lead sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Sponsor class: OTHER
First posted: 2014-01-17
Enrollment: 60
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Change in Scores of TCM clinical symptom and the clinical scoring system of Toronto (TCSS)
timeFrame: 24weeks
Secondary outcomes:
measure: Change in Nerve conduction velocity
timeFrame: 24Weeks
Other outcomes:
measure: Number of participants with adverse events
timeFrame: 24Weeks
Locations:
Study officials:
affiliation: Guang'anmen Hospital
name: Xiaolin Tong, PHD
role: STUDY_CHAIR
References: