Chinese Herbs, Diabetes, Diabetic Peripheral Neuropathy
Conditions
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.
Interventions
DRUGXuebi formula
DRUGplacebo
Sponsors
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
30 Years to 70 Years
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Scores of TCM clinical symptom and the clinical scoring system of Toronto (TCSS) | 24weeks | 1. Scores of TCM clinical symptom. Using statistical table score, main symptoms and secondary symptoms according to the degree is divided into light, medium, heavy, the main symptoms were recorded 2, 4, 6 points, the secondary symptoms were recorded 1, 2, 3 points. No symptomatic record 0 points. Before the study, of 4, 8, 12, 16, 20, 24 week each recorded 1 times. Description of tongue and pulse only, not scoring. 2. the clinical scoring system of Toronto (TCSS). TCSS includes a score of neural symptoms, nerve reflex scores and sensory examination , a total of 19 points.Before the study, of 4, 8, 12, 16, 20, 24 week each scoring 1 times.According to the classification standard, 0-5 points does not have DPN, 6-8 points for mild DPN, 9-11 points for moderate DPN, 12-19 points for severe DPN. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Nerve conduction velocity | 24Weeks | Nerve conduction velocity are recorded at 0,12th,24th weeks. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with adverse events | 24Weeks | Adverse events with records at any time. |
Contacts
Primary Contactqiang zhou, PHD
Outcome results
None listed