A Study of Xuebi Formula for Diabetic Peripheral Neuropathy(Qi-deficiency and Blood-stasis) (NCT02039544)

01

Study 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)

Read the 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.

02

Conditions studied

Diabetic Peripheral Neuropathy
Diabetes
Chinese Herbs

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03

In context

Peripheral Nervous System Diseases

1,003 studies on the registry are indexed under Peripheral Nervous System Diseases; 177 are open to participants now.

This study's planned enrollment of 60 is close to the median of 60 across 768 interventional studies indexed under Peripheral Nervous System Diseases.

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Lead sponsor

Guang'anmen Hospital of China Academy of Chinese Medical Sciences is the lead sponsor of 133 studies on the registry; 36 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible: 30 Years to 70 Years
Sexes eligible: All
Accepts healthy volunteers: No

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.

05

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)
Enrollment: 60 participants (estimated)

Study arms

Experimental
Xuebi formula
Xuebi formula , one dosage ,every day, treat 6 months.
Drug: Xuebi formula
Placebo comparator
Placebo
placebo,has the same taste and color as Xuebi formula one dosage ,every day, treat 6 months.
Drug: placebo

Interventions

DrugXuebi formula
Drugplacebo

06

What researchers measure

Primary outcomes

Change in Scores of TCM clinical symptom and the clinical scoring system of Toronto (TCSS)
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.
Time frame: 24weeks

Secondary outcomes

Change in Nerve conduction velocity
Nerve conduction velocity are recorded at 0,12th,24th weeks.
Time frame: 24Weeks

Other outcomes

Number of participants with adverse events
Adverse events with records at any time.
Time frame: 24Weeks

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Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jan 17, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

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Registry details

Key details

Study ID: NCT02039544
Lead sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Responsible party: Fengmei Lian (chair, Guang'anmen Hospital of China Academy of Chinese Medical Sciences) — Principal investigator
First posted: Jan 17, 2014
Start date: Jan 2014
Primary completion: Jan 2015 (estimated)
Completion: May 2015 (estimated)
Last update: Jan 17, 2014

Study contacts

qiang zhou, PHD

Contact

15101016416@126.com

15101016416 ext. 0086

Xiaolin Tong, PHD

study chair · Guang'anmen Hospital

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

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