Qiming granule in treating type 2 diabetic kidney disease patients:study protocol for a randomized controlled trial

Background:Diabetic kidney disease(DKD)is a chronic renal microvascular complication associated with abnormal glucose metabolism.According to traditional Chinese medicine(TCM)theory,Qi and Yin deficiency with blood stasis(the name of TCM symptoms,its main clinical features are fatigue,dry mouth,red or pale tongue,weak pulse,etc.)is the primary TCM syndrome of DKD,and Qiming granule(QMG)is suitable for the treatment of Qi and Yin deficiency with blood stasis syndrome.In view of this,we designed a randomized controlled trial to assess whether QMG is efficacious and safe in treating DKD patients.Methods:This protocol is for a randomized,double-blind,placebo-controlled,parallel group,six-centre clinical trial.A total of 180 participants will be randomized into the QMG group or placebo group,with a 1:1 ratio.The study will last for 50 weeks,including a 2-week run-in period,24 weeks of intervention,and 24 weeks of follow-up.The experimental intervention will be QMG,and the control intervention will be a placebo.The primary outcome will be the 24h urinary albumin excretion ratio and the change in the albumin-to-creatinine ratio.The secondary outcome will be evaluation of renal function,fundus changes,management of blood lipids,TCM symptom improvement and safety assessments.Adverse events will be recorded during the trial.Discussion:This study is a randomized controlled trial to test the effectiveness and safety of QMG for DKD patients.The findings of this study will help to provide evidence-based recommendations in treating DKD patients.Trial registration:Chinese Clinical Trial Registry,ChiCTR-TRC-12002953.Registered 23 December 2012.

Clinical study of Qiming granule combined with compound anisodine injection in the treatment of diabetic retinopathy

Objective:To investigate the clinical study of Qiming granule combined with compound anisodine injection in the treatment of diabetic retinopathy.Methods:104 patients with nonproliferative diabetic retinopathy admitted to department of ophthalmology in Xishui Hospital Affiliated to Hubei University of science and technology from September 2016 to May 2018 were selected as the study subjects.According to the principle of treatment,they were divided into 52 cases in the control group and 52 cases in the treatment group,the clinical efficacy,blood sugar and lipid levels,hemorheological changes and adverse reactions were compared between the two groups.Results:The total effective rate difference between the treatment group(92.31%)and the control group(71.15%)was statistically significant(χ^(2)=7.792,P=0.005).After treatment,the two groups of fasting plasma glucose(FPG),hemoglobin A1c(HbA1c),total cholesterol(TC),low density lipoprotein-cholesterol(LDL-C),whole blood high-viscosity,whole blood cut viscosity,whole blood low-cut viscosity,plasma viscosity,number of microangioma and area of the hemorrhage were significantly lower than before treatment(P<0.05),and the levels of FPG,HbA1c,TC,LDL-C,whole blood highviscosity,whole blood cut viscosity,whole blood low-cut viscosity,plasma viscosity,number of microangioma and area of the hemorrhage in the treatment group were significantly lower than those in the control group(χ^(2)=0.122,P=0.727).Conclusions:Qiming granule combined with compound anisodine injection can effectively improve the clinical efficacy of patients with non-proliferative DR,and its mechanism may be related to improve blood sugar and blood lipid levels and correct blood rheology disorder,reduce microangioma and hemorrhage.It has clinical promotion significance.

Research of the clinical efficacy of Qiming Granule in treatment of diabetic nephropathy by meta-analysis

Objective:To systematically evaluate the clinical efficacy of Qiming Granule combined with conventional therapy in improving diabetic nephropathy.Methods:The Chinese and English databases such as Wanfang,VIP,CNKI,PubMed,Cochrane library and Web of Science database were searched.The searching time was from the database was established to March 1,2021.The papers were screened strictly according to the inclusion and exclusion criteria.The inclusion risk assessment tool provided by the Cochrane Collaboration was used to evaluate the included literature,the data was analyzed using STATA 12.0 software.Results:Twelve papers were included,involving 1369 patients.The results of meta-analysis showed that Qiming Granule combined with conventional treatment had statistical significance in improving the clinical total effective rate[RR=1.24,95%CI(1.12,1.36)],urinary albumin excretion rate[SMD=-2.68,95%CI(-3.86,-1.50)],creatinine[SMD=-1.46,95%CI(-1.84,-1.08)],urea nitrogen[SMD=-2.61,95%CI(-3.85,-1.36)],fasting blood glucose[SMD=-1.17,95%CI(-2.03,-0.31)]and cystatin C[SMD=-3.26,95%CI(-4.65,-1.87)]of patients with diabetic nephropathy.Conclusion:The combination of conventional therapy and Qiming Granule can improve the clinical effect for diabetic nephropathy.However,due to the low level of overall literature evidence,high risk and some kind of publication bias,it still needs more high-quality and large-scale clinical studies for further verification.

Effect of Qiming Granule(芪明颗粒) on Retinal Blood Circulation of Diabetic Retinopathy:A Multicenter Clinical Trial

Objective： To objectively assess the effect of Qiming Granule （芪明颗粒） in the treatment of diabetic retinopathy （DR） by fluorescence fundus angiography （FFA）. Methods： In a multi-center, randomized, parallel controlled clinical trial, patients with DR were randomly assigned to the control group （calcium dobesilate capsule） and the test group （Qiming Granule）. Changes in the retinal blood circulation time were recorded by FFA after 3 months of medication. Results： Significant reduction was observed in the retinal arterio-venous circulation time （AVCT） in both groups （P〈0.01）, the value was 7.635 ± 3.149 s before treatment and 5.165 ±3.382 s after treatment in the treated group, and 7.737±3.413 s and 5.313±3.472 s in the control group respectively. Qiming Granule also reduced the arm-to-retinal circulation time （ARCT, P〈0.05）. The value was 17.867± 3.872 s before treatment and 15.643 ± 4.648 s after treatment in the treated group, and 17.217 ± 3.833 s and 16.312± 3.613 s in the control group （P〉0.05） respectively. The ARCT in the tested group was reduced, with a statistically significant difference post-medication （P〈0.01）. Conclusion： As a Chinese medicine complex prescription, Qiming Granule may alleviate retinal hypoxia and ischemia by increasing retinal blood flow and improving the blood circulation.

Stationary Treatment Compared with Individualized Chinese Medicine for Type 2 Diabetes Patients with Microvascular Complications:Study Protocol for a Randomized Controlled Trial

Background： Microvascular complications in type 2 diabetes （T2DM）, including diabatic retinopathy （DR）, diabetic kidney disease （DKD）, diabetic peripheral neuropathy （DPN） are the leading causes of visual loss, end-stage renal disease or amputation, while the current therapies are still unsatisfactory. Chinese medicine （CM） has been widely used for treating diabetic mettitus. However, most of the previous studies focused on the single complication. The role of CM treatment in T2DM patients with 2 or multiple microvascular complications is not clear. Objective： To appraise the curative effect of CM in T2DM patients with 2 or multiple microvascular complications, and to compare the effects of stationary treatment and individualized treatment in T2DM patients with microvascular complications. Methods： This trial will be an 8-center, randomized, controlled study with 8 parallel groups. A total of 432 patients will be randomized to 8 groups： DR study group （32 cases） and a corresponding control group （32 cases）, DR＋DKD study group （64 cases） and a corresponding control group （64 cases）, DR＋DPN study group （64 cases） and a corresponding control group （64 cases）, DR＋DKD＋DPN study group （56 cases） and a corresponding control group （56 cases）. The control group will receive stationary treatment, and the study group will receive individualized treatment based on CM syndrome differentiation in addition to stationary treatment. The study duration will be 50 weeks, comprising a 2-week run-in period, 24 weeks of intervention, and 24 weeks of follow-up. The outcomes will assess efficacy of treatment, improvement in CM symptoms, safety assessments, adherence to the treatment, and adverse events. Conclusion： This study will provide evidence of evidence-based medicine for CM treatment in two or multiple microvascular complications caused by T2DM. （Registration No. ChiCTR-IPR-15007072）

Evaluation of individualized treatment of nonproliferative diabetic retinopathy:a multicenter,randomized,parallel-controlled study

OBJECTIVE:To evaluate the differences in the efficacy of stationary treatment and individualized treatment for patients with nonproliferative diabetic retinopathy(NPDR).METHODS:This study was a randomized,controlled,multicenter clinical trial.Participants with NPDR were randomized into the stationary treatment group or the individualized treatment group.The stationary treatment group was given the basic treatment and Qiming granules,and the individualized treatment group was given the basic treatment,Qiming granules,and individualized Chinese herbal medicines over a 12-week period.The individualized therapeutic formula was also changed over time to adjust to the changes in the clinical presentation of the patient.We conducted observations of fundus retinal exudation and hemorrhage,visual acuity,Traditional Chinese Medicine symptom scores and other indicators.RESULTS:A total of 140 participants with NPDR were randomized into the stationary treatment group or the individualized treatment group,and 132 participants completed this study.Following the 12-week treatment,significant improvements in both primary and secondary outcomes were observed in the stationary and individualized treatment groups.No remarkable difference in the primary outcomes between the two groups was observed.However,there was a significant difference in the Traditional Chinese Medicine symptom scores(18±7 vs 15±6;P<0.05).There were no severe adverse effects.CONCLUSION:Compared with stationary treatment,individualized treatment is more effective at relieving the Traditional Chinese Medicine symptoms and improving vision and fundus lesions at 12 weeks post treatment.