Tianjin, China
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Ling S.,Monash University | Luo R.-Z.,Tasly Pharmaceutical Co | Nheu L.,Monash University | Guo Z.-X.,Tasly Pharmaceutical Co | And 2 more authors.
Journal of Cardiovascular Pharmacology | Year: 2012

T89 (Dantonic) is a modern herbal medicine currently used in Chinese hospitals for the management of ischemic heart disease. This dose-escalation clinical trial aims to assess tolerability of Western people to T89. Healthy Australian adults of non-Asian background orally took a single dosage of 6, 8, 10, 12, 13, 14, 15, or 16 T89 capsules (6 people for each dose) and were assessed with respect to symptoms and physical signs, electrocardiogram, hematology, plasma biochemistry, and urinalysis. Secondary objectives were to determine the dose-limiting toxicity and maximum-tolerated dose. It found that a single dose of T89 up to 16 capsules was not associated with significant adverse events or abnormalities in clinical laboratory tests and electrocardiogram parameters, except minor symptoms reported included mild and transient dizziness, stomach discomfort, diarrhea, and involuntary muscular contraction. The incident rate of these symptoms was generally low (1/30, 3.3%) but increased (7/18, 38.9%) in higher dose (≥14 capsules) groups. No defined dose-limiting toxicity events occurred; so the study could not define the maximum-tolerated dose. In conclusion, a single dose of T89 up to 13 capsules, 4 times of a regular therapeutic dosage, is generally safe and tolerated by individuals of non-Asian background. © 2012 by Lippincott Williams & Wilkins.


PubMed | Henan University, Peking Union Medical College, Nanjing Medical University, Tianjin University and 5 more.
Type: | Journal: Journal of child psychology and psychiatry, and allied disciplines | Year: 2015

Tourette syndrome (TS) is a common tic disorder in children and adolescents. There is preliminary evidence that herbal medicine may possess the potential to treat tics. The purpose of this study was to formally evaluate the efficacy and safety of 5-Ling Granule (5-LGr), a proprietary polyherbal product, for the treatment of patients with TS in comparison with tiapride and placebo.In this multisite, double-blind, double-dummy, randomized, placebo-controlled trial, 603 patients with TS aged 5-18years were randomly assigned to treatment with placebo (n=117), tiapride (n=123, 200-400mg/day) or 5-LGr (n=363, 15-22.5g/day) for 8weeks. The primary outcome was measured using the Yale Global Tic Severity Scale (YGTSS) and its subscales, total tic Score (TTS) and tic-related impairment. Incidence of adverse events was compared among the three groups.While tics of all patients were reduced over time, 5-LGr and tiapride treatment produced significantly greater improvement on the YGTSS overall scale and subscale for TTS and impairment at endpoint than the placebo. Seventy-four percentage of patients in the 5-LGr arm and 68.3% in the tiapride arm had clinical response and these rates of response were significantly higher than those on placebo (44.0%, p<.001). The incidence of overall adverse events was significantly fewer for patients on placebo and 5-LGr compared to tiapride (11.2% and 13.8% vs. 26.0%, p=.002); in particular physical tiredness, dizziness and sleep disturbance.The clinical efficacy of 5-LGr is comparable to tiapride in reducing tics. Its safety profile is better than tiapride. 5-LGr can be considered a safe and effective therapy for TS (Trial registration: www.clinicaltrials.gov: NCT01501695).


Wang P.,Tianjin University | Wang P.,Tasly Pharmaceutical Co. | Sun H.,Tianjin University | Sun H.,Tasly Pharmaceutical Co. | And 6 more authors.
Journal of Clinical Pharmacology | Year: 2014

This open-label, multi-dose, single-center, sequential, inpatient study evaluated the effects of a two herb combination drug (T89, Danshen plus Sanqi) on the steady-state pharmacodynamics (PD) and pharmacokinetics (PK) of warfarin in 24 healthy volunteers. Twenty-three subjects attained a stable international normalized ratio (INR) by taking warfarin alone prior to 1-week of added-on use of T89. INR was not increased after the addition of T89 for 7 days (P>.05). The 90% confidence interval (CI) of the geometric mean ratio for maximum plasma concentrations (Cmax) and area under curve (AUClast) of both R- and S-warfarin when warfarin was administered with or without T89 was within the 0.80 to 1.25 equivalence ratio. These results indicate that T89 has no effect on the steady-state PD and PK of warfarin. Warfarin and T89 dose adjustments are not required when these two drugs are co-administrated in clinical practice.© 2013, The American College of Clinical Pharmacology.


Lian F.,Chinese Academy of Sciences | Wu L.,Chinese Academy of Sciences | Tian J.,Chinese Academy of Sciences | Jin M.,China Japan Friendship Hospital | And 10 more authors.
Journal of Ethnopharmacology | Year: 2015

Ethnopharmacological relevance Salvia miltiorrhiza (Danshen in Chinese) is a common traditional Chinese herbal medicine often used to treat many medical conditions. The Compound Danshen Dripping Pill (CDDP) is a danshen-containing Chinese herbal product for the treatment of cardiovascular diseases. However, to date, no controlled clinical studies have been conducted to evaluate the effects of CDDP on diabetic retinopathy (DR). Aim of the study The present large-scale clinical trial was designed to assess the effectiveness and safety of CDDP in treating patients with non-proliferative diabetic retinopathy (NPDR). Materials and methods 223 NPDR patients were enrolled in this controlled trial. Subjects received oral study medications three times daily for 24 weeks. The four groups were placebo, low-dose (270 mg), mid-dose (540 mg) and high dose (810 mg herbal medicine). Primary endpoints were changes in fluorescence fundus angiography (FFA) and fundoscopic examination parameters. Results and discussion At 24 weeks, for the FFA, the percent of "Excellent" and "Effective" in the high-dose and mid-dose CDDP groups was 74% and 77%, respectively, very significantly higher than 28% in the placebo group (P<0.001). For fundoscopic examination, the percent of "Excellent" and "Effective" in the high-dose and mid-dose CDDP groups was 42% and 59%, respectively, very significantly higher than 11% in the placebo group (P<0.001). No adverse events with clinical significance were observed. Conclusions DR is a severe microvascular complication of diabetes and a major cause of adult blindness worldwide. Our clinical trial data demonstrated the therapeutic value and safety of a danshen-containing Chinese herbal medicine in patients with diabetic retinopathy. © 2015 Elsevier Ireland Ltd. All rights reserved.


PubMed | Chinese Academy of Sciences, Jiangsu Province Hospital of Traditional Chinese Medicine, Tasly Pharmaceutical Co., University of Chicago and 6 more.
Type: | Journal: Journal of ethnopharmacology | Year: 2015

Salvia miltiorrhiza (Danshen in Chinese) is a common traditional Chinese herbal medicine often used to treat many medical conditions. The Compound Danshen Dripping Pill (CDDP) is a danshen-containing Chinese herbal product for the treatment of cardiovascular diseases. However, to date, no controlled clinical studies have been conducted to evaluate the effects of CDDP on diabetic retinopathy (DR).The present large-scale clinical trial was designed to assess the effectiveness and safety of CDDP in treating patients with non-proliferative diabetic retinopathy (NPDR).223 NPDR patients were enrolled in this controlled trial. Subjects received oral study medications three times daily for 24 weeks. The four groups were placebo, low-dose (270 mg), mid-dose (540 mg) and high dose (810 mg herbal medicine). Primary endpoints were changes in fluorescence fundus angiography (FFA) and fundoscopic examination parameters.At 24 weeks, for the FFA, the percent of Excellent and Effective in the high-dose and mid-dose CDDP groups was 74% and 77%, respectively, very significantly higher than 28% in the placebo group (P<0.001). For fundoscopic examination, the percent of Excellent and Effective in the high-dose and mid-dose CDDP groups was 42% and 59%, respectively, very significantly higher than 11% in the placebo group (P<0.001). No adverse events with clinical significance were observed.DR is a severe microvascular complication of diabetes and a major cause of adult blindness worldwide. Our clinical trial data demonstrated the therapeutic value and safety of a danshen-containing Chinese herbal medicine in patients with diabetic retinopathy.


Tong X.L.,Chinese Academy of Sciences | Wu S.T.,Tianjin University of Traditional Chinese Medicine | Lian F.M.,Chinese Academy of Sciences | Zhao M.,Tasly Pharmaceutical Co. | And 10 more authors.
Diabetes, Obesity and Metabolism | Year: 2013

Aim: TM81 (or Tang-Min-Ling-Wan) is a Chinese medicine. Previous studies suggested that this medicine is effective for treating type 2 diabetes. This controlled trial evaluated the safety and effectiveness of TM81 in the treatment of type 2 diabetic patients. Methods: This study was a large-scale controlled clinical trial to evaluate the safety and effectiveness of TM81 on type 2 diabetes. After a 2-week run-in period, 480 overweight type 2 early-stage diabetic patients [35-65years old, HbA1c ≥ 7.0%, fasting plasma glucose (FPG) 7.0-13.9mM or 2h plasma glucose (PG)>11.1mM, body mass index (BMI)≥24kg/m2] were enrolled. These patients were divided into a TM81 group and placebo group in a 3:1 ratio. The subjects received 6g TM81 or placebo, three times daily for 12weeks. Results: After treatment, the HbA1c decrease was 1.02% in the TM81 group versus 0.47% in the placebo group. The FPG decreased 0.8±0.1 mM in the TM81 group versus an increase of 0.2±0.2mM in the placebo group. The PG decreased 2.7±0.3 mM in the TM81 group versus a decrease of 0.9±0.4 mM in the placebo group (all p<0.05). The TM81 was more effective for patients with higher baseline HbA1c levels. The TM81 group also showed improved β-cell function and increased homeostatic model assessment (HOMA)-β. In addition, body weight, BMI and waist circumference of subjects in the TM81 group were reduced, and the symptoms related to diabetes were improved. There were no significant differences in the types and frequency of adverse reactions between the two groups. Conclusions: The data showed that TM81 is effective in controlling blood glucose level and is safe to use in patients with early-stage type 2 diabetes. © 2012 Blackwell Publishing Ltd.


Li W.,Tasly Pharmaceutical Co. | Zhou S.-P.,Tasly Pharmaceutical Co. | Jin Y.-P.,Tasly Pharmaceutical Co. | Huang X.-F.,China Pharmaceutical University | And 9 more authors.
Fitoterapia | Year: 2014

Two new trimeric caffeic acids, named salvianolic acids T and U (1 and 2), were isolated from the underground part of Salvia miltiorrhiza. Their structures, consisting of three caffeic acid units, were determined based on extensive 1D- and 2D-spectroscopic analyses and electronic circular dichroism (ECD) calculations. © 2014 Elsevier B.V.


Tong X.-L.,Chinese Academy of Sciences | Lian F.-M.,Chinese Academy of Sciences | Zhou Q.,Chinese Academy of Sciences | Xu L.-P.,Beijing University of Chinese Medicine | And 13 more authors.
American Journal of Chinese Medicine | Year: 2013

A prospective multicenter clinical trial was conducted to compare the beneficial effects of a Chinese herbal medicine formula Jiangzhuoqinggan (JZQG) and western antihypertension drug irbesartan. JZQG is mainly composed of rhubarb, coptis, cassia, and uncaria. A total of 240 patients with mild to moderate hypertension were enrolled in the trial. Patients were assigned into two groups after screening: JZQG group and the irbesartan group. After four weeks of treatment, we compared the changes in routine blood pressure, 24 h ambulatory blood pressure, and waist circumference. There was a significant reduction in systolic blood pressure and diastolic blood pressure in the JZQG group (both p < 0.01). There were no significant differences between the reduction of systolic and diastolic blood pressures in the two treatment groups. From the 24 h ambulatory blood pressure measurement, the JZQG group showed a greater reduction in both systolic and diastolic blood pressures (in both daytime and nighttime) than the irbesartan group. Furthermore, there was a significant difference in waist circumference in the JZQG group (1.51 cm reduction; P < 0.05) but not the irbesartan group (0.42 cm). Thus, the JZQG formula may have therapeutic value in patients with both hypertension and metabolic syndrome. © 2013 World Scientific Publishing Company.


Zhou Q.,Chinese Academy of Sciences | Chang B.,Tianjin Medical University | Chen X.-Y.,Chinese Academy of Sciences | Zhou S.-P.,Tasly Pharmaceutical Co. | And 11 more authors.
American Journal of Chinese Medicine | Year: 2014

Obesity is a serious medical problem worldwide. As a holistic therapy, traditional Chinese medicine (TCM) may have a potential in obesity management. In this controlled trial, we evaluated the safety and effectiveness of Xin-Ju-Xiao-Gao-Fang (XJXGF), a TCM herbal formulation, in 140 obese subjects over a 24-week period. The XJXGF formula mainly consists of rhubarb, coptis, semen cassia, and citrus aurantium. Subjects with body mass index (BMI) 28-40 kg/m2 were recruited at 5 centers in China. We assessed the changes in subjects' body weight, its related parameters, and the reduction of insulin resistance (IR) after administration of XJXGF formula or low-dose XJXGF (10% of the XJXGF formula, as control). After 24-week treatment, among participants in the XJXGF formula group and low-dose XJXGF group, the mean ± SE changes in the body weight were -3.58 ± 0.48 and -1.91 ± 0.38 kg, respectively (p < 0.01). The changes in the IR-index of two groups were -2.65 ± 1.04 and -1.58 ± 1.3, respectively (p < 0.05). There were no serious adverse events reported during the 24-week trial. Participants reported 7 minor adverse events, 4 in the XJXGF formula group and 3 in the low-dose XJXGF group (p = 0.578). Future studies are needed to investigate the clinical utility of this TCM formulation in the treatment of obese subjects. © 2014 World Scientific Publishing Company & Institute for Advanced Research in Asian Science and Medicine.


PubMed | Tasly Pharmaceutical Co. and China Pharmaceutical University
Type: | Journal: Fitoterapia | Year: 2014

Two new trimeric caffeic acids, named salvianolic acids T and U (1 and 2), were isolated from the underground part of Salvia miltiorrhiza. Their structures, consisting of three caffeic acid units, were determined based on extensive 1D- and 2D-spectroscopic analyses and electronic circular dichroism (ECD) calculations.

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