[Translation] A randomized, double-blind, methylcobalamin-controlled, multicenter clinical trial of Xiaoke Tongluo capsule in the treatment of type 2 diabetic peripheral neuropathy

研究消渴通络胶囊对2型糖尿病周围神经病变（气阴两虚兼血瘀脉络证）患者的有效性和安全性，为Ⅲ期临床试验提供依据。

[Translation]

To study the efficacy and safety of Xiaoke Tongluo Capsule in patients with type 2 diabetic peripheral neuropathy (Qi and Yin deficiency with blood stasis in the meridians syndrome) and provide a basis for Phase III clinical trials.

Start Date24 Mar 2010

Sponsor / Collaborator

Guangzhou Hongyun Medical Scientifical & Technological Co.

100 Clinical Results associated with Xiaoke Tongluo Capsule

100 Translational Medicine associated with Xiaoke Tongluo Capsule

100 Patents (Medical) associated with Xiaoke Tongluo Capsule

Literatures (Medical) associated with Xiaoke Tongluo Capsule

01 Jul 2023·Zhongguo Zhong yao za zhi = Zhongguo zhongyao zazhi = China journal of Chinese materia medica

[Network Meta-analysis of Qi-supplementing and Yin-nourishing Chinese patent medicines in treatment of early diabetic nephropathy].

Article

Author: Li, Ji-Xin ; Wang, Wen-Ru ; Zhang, Xu-Ming ; Xie, Yan-Ming ; Yu, Ren-Huan ; Yang, Jia-Yi

This study aimed to evaluate the efficacy of Qi-supplementing and Yin-nourishing Chinese patent medicine in the treatment of early diabetic nephropathy(DN) by network Meta-analysis to explore the Chinese patent medicine with optimal efficacy and provide references for preventing renal deterioration and delaying the progression of early DN. Eight databases, including CNKI, Wanfang, VIP, SinoMed, PubMed, EMbase, Cochrane Library, and Web of Science, were searched for clinical randomized controlled trial(RCT) of Qi-supplementing and Yin-nourishing Chinese patent medicines in the treatment of early DN. After the literature mee-ting the inclusion criteria was screened, the quality of the literature was evaluated using the Cochrane risk-of-bias tool, and network Meta-analysis was performed using the BUGSnet package in R 4.2.1. Seventy-two research articles with a sample size of 6 344 cases were included, involving eight Chinese patent medicines and seven outcome indicators. The results of the network Meta-analysis showed that(1)in terms of improving urinary albumin excretion rate(UAER), Chinese patent medicines combined with conventional treatment were superior to conventional treatment, and Qiyao Xiaoke Capsules + conventional treatment was optimal.(2)In terms of reducing serum crea-tinine(Scr), Bailing Capsules + conventional treatment had superior efficacy.(3)In terms of reducing 24-hour urine total protein(24hUTP), Shenyan Kangfu Tablets + conventional treatment and Jinshuibao Capsules + conventional treatment had equivalent efficacy, and Shenyan Kangfu Tablets + conventional treatment was superior.(4)In terms of improving fasting blood glucose(FBG), Shenyan Kangfu Tablets + conventional treatment had superior efficacy.(5)In terms of improving total cholesterol(TC), Qiyao Xiaoke Capsules +conventional treatment had superior efficacy.(6)In terms of reducing triglyceride(TG), Bailing Capsules + conventional treatment had superior efficacy.(7)In terms of safety, the occurrence of adverse reactions was reported in seven interventions, but due to the large clinical heterogeneity, the quantitative analysis could not be performed. Overall, Qi-supplementing and Yin-nourishing Chinese patent medicines combined with conventional treatment were superior to conventional treatment alone in the treatment of early DN. The results showed that Qi-supplementing and Yin-nourishing Chinese patent medicines combined with conventional treatment had good clinical efficacy, and they could significantly reduce renal function indicators such as UAER, Scr, and 24hUTP, and reduce blood sugar and blood lipid, which can provide evidence-based support for the treatment of early DN. However, due to the differences in the quantity and quality of the included research articles, large-sample, multi-center, high-quality studies are still needed for further verification.

01 Dec 2012·Zhongguo Zhong xi yi jie he za zhi Zhongguo Zhongxiyi jiehe zazhi = Chinese journal of integrated traditional and Western medicine

[Clinical observation of qiyao xiaoke capsule in intervening 76 patients with type 2 pre-diabetes].

Article

Author: Zhang, Xiao-ke ; Cui, Na ; Ni, Qing

OBJECTIVETo observe the clinical effects of Qiyao Xiaoke Capsule (QXC) on patients with type 2 pre-diabetes.METHODSTotally 116 pre-diabetes patients were randomly assigned to the Chinese medicine group (CM, 76 cases) and the blank control group (BC, 40 cases) in the ratio of 2: 1. All patients received proper diet control, health education, and exercises, and so on. Besides, patients in the CM group took QXC (0.4 g/pill), 6 pills each time, three times a day. But patients in the BC group were intervened by life style alone. The fasting blood glucose (FBG), postprandial blood glucose (PBG), insulin (FINS, 2h INS), glycosylated hemoglobin (HbAlc), blood lipids (TG, TC, HDL-C, and LDL-C), and efficacy of CM symptoms were observed in the two groups before and after intervention. The sequelae were observed at the end of the treatment and at follow-ups.RESULTSAfter treatment FBG, PBG, and HbA1c decreased in all patients of the two groups (P<0.05, P<0.01), with 2 h PBG decreased more significantly. But there was no statistical difference between the two groups (P>0.05). The two methods could improve the secretion of FINS. Especially 2 h INS decreased more significantly in the CM group, showing statistical difference when compared with the BC group (P<0.05). The two methods could improve the metabolism of blood lipids. CM could significantly lower TG and elevate HDL-C, showing statistical difference when compared with before treatment (P<0.05). After treatment the CM symptoms were obviously improved, showing statistical difference when compared with the BC group (P<0.05). The normalization rate was better in the CM group than in the BC group at the end of the treatment and at follow-ups (P<0.05).CONCLUSIONSQXC combined life style intervention could improve fasting and postprandial insulin secretion of type 2 pre-diabetes patients, regulate glycolipid metabolism, correct the insulin resistance state, and improve the symptoms of qi-yin insufficiency. It could postpone or hinder the occurrence and development of type 2 diabetes. It was more effective and durable than changing the life style alone.

01 Oct 2010·Zhongguo Zhong xi yi jie he za zhi Zhongguo Zhongxiyi jiehe zazhi = Chinese journal of integrated traditional and Western medicine

[Effects of Qiyao Xiaoke capsule on glycolipid metabolism in liver and skeletal muscle of rats with catch-up growth induced by high-fat diet].

Article

Author: Zhang, Xiao-Ke ; Ma, Li ; Han, Ki-Ping

OBJECTIVETo observe the effect of Qiyao Xiaoke Capsule (QXC, a Chinese preparation for invigorating qi and nourishing yin) on glycolipid metabolism in the liver and skeletal muscle of rats with catch-up growth (CUG) induced by high-fat diet.METHODSCUG model rats were made by limiting forge followed by high-fat diet, and intervened with different dosages [1.8 (g/kg x d), 0.6 g/(kg x d)] of QXC. And the experiment was controlled with pioglitazone. Levels of blood glucose, serum free fatty acid (FFA), serum insulin (Fins), plasma adiponcetin (AC) and insulin resistance index (IRI) as well as the weights of peri-epididymis and peri-renal fat and their ratio to body weight were observed 8 weeks later. The contents of total cholesterol (TC), triglyceride (TG) and glucose uptake in skeletal muscle and liver were also determined.RESULTSInsulin resistance in CUG rats can be induced by high-fat diet. Compared with the un-treated model rats, levels of Fins and AC were higher, IRI and FFA were lower in CUG rats after intervened by QXC (P < 0.05 or P < 0.01). Moreover, QXC at large dose showed the effects of reducing TG content in liver and skeletal muscle, advancing the glucose uptake in skeletal muscle, displaying an efficacy similar to that of pioglitazone (P > 0.05).CONCLUSIONQXC could improve the glycolipid metabolism in high-fat diet-induced CUG rats through different pathways of intervention to alleviate/delay the occurrence and development of insulin resistance in the liver and skeletal muscle.

100 Deals associated with Xiaoke Tongluo Capsule

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Indication	Highest Phase	Country/Location	Organization	Date
type 2 diabetes mellitus with peripheral neuropathy	Phase 2	CN	Guangzhou Hongyun Medical Scientifical & Technological Co.	24 Mar 2010

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