A multi-center, double-blind, placebo-controlled, randomized trial for effect of Longxue Tongluo capsule in treatment of patients of atherosclerotic thrombotic cerebral infarction with blood-stasis syndrome in convalescence / 中国中药杂志

To evaluate the effectiveness and safety of Longxue Tongluo capsule on patients of atherosclerotic thrombotic cerebral infarction convalescence with blood-stasis syndrome, a double-blind, randomized controlled, multi-center clinical trial was conducted. A total of 160 eligible patients were randomly divided into treatment group and control group, with 80 patients in each group, and all of them were orally given Troxerutin pill(three pills each time, three times daily). Longxue Tongluo capsule was applied in the treatment group, while placebo was applied in the control group(two capsules each time, three times daily) for 4 weeks. Main outcomes were measured by ITT analysis. The neurological function deficits scale showed a decrease of 5.17±2.60 in the treatment group, while 4.31±2.31 in the control group, with significant differences between the two groups(P<0.05); the reduction rate in the treatment group (37.2±15.8)% was significantly higher than that in the control group (29.9±15.3)%(P<0.05). In terms of the comprehensive curative effect by ITT, the effective rates in the treatment and control group were 31.6% and 13.5%, respectively(P<0.05). With respect to the efficacy of traditional Chinese medicine syndrome by ITT, the total effective rate of the treatment group was significantly higher than the control group 88.2% vs 68.9%, P<0.05. Three cases of adverse events occurred in this study, including 1 case of diarrhea in treatment group and 2 cases of skin itch and upper respiratory infection in control group. In conclusion, Longxue Tongluo capsule is effective and safe in the treatment of patients of atherosclerotic thrombotic cerebral infarction convalescence with blood-stasis syndrome, and can effectively alleviate the patients' nerve function defect degree and invalidism, with a good effect on blood stasis syndrome.

Effects and safety of varying doses of guizhi fuling capsule in patients with primary dysmenorrhea: a multi-center, randomized, double-blind, placebo-controlled clinical study / 中国中药杂志

To evaluate the effects and safety of varying doses of Guizhi Fuling capsule on treating primary dysmenorrhea. From August 2010 to March 2011, 240 subjects (aged 18-30) with primary dysmenorrheal, were enrolled in 8 sites. They were randomized into Guizhi Fuling capsule high dose group, low dose group and placebo control group, 80 cases in each group. These patients were treated for three consecutive menstrual cycles, then were followed up in another three consecutive menstrual cycles. Visual analogue scales (VAS) was used to determine the pain intensity. During the treatment, the high-, low-dose and placebo groups efficiency on pain relief are 68.42%, 67.57% and 47.89% respectively. Guzhi Fuling (included high- and low- dose group) significantly relieves the pain compared to placebo. In follow-up, Guzhi Fuling groups are still superior to the placebo group (73.68%, 72.97% and 53.52%). During the treatment, pain duration reduces 57.88% in high dose group, while 46.17% in low dose group, and 30.40% in placebo group. In follow-up, pain lasting time decrease 67.93%, 53.56%, 47.46%, respectively. Guizhi Fuling significantly reduces the pain duration compared to placebo and high-dose is better than low-dose. The efficacy of Guzhi Fuling (high- and low-dose) displays certain dosage-effect relationship. Among these group, no serious adverse event was reported. Guizhi Fuling capsule at high or low dose significantly relieves the pain, improves symptoms, reduces the duration of pain, and has a better overall treatment effect and long-term treatment effect in patients with primary dysmenorrhea.

Phase III clinical trial of Diterpene Ginkgolides Meglumine Injection for syndrome of stagnant phlegm blocking collaterals in convalescence of atherosclerotic thrombotic cerebral infarction / 中草药

Objective: To evaluate the efficacy and safety of Diterpene Ginkgolides Meglumine Injection (DGMI) in the treatment of recovered stroke with syndrome of stagnant phlegm blocking collaterals, especially the clinical efficacy in improving the function of language and movements. Methods: The clinical trial was carried out by the methods of stratification and r andomization (416 cases of patients with atherosclerotic thrombotic cerebral infarction (ATCI) were r andomly divided into experimental and control groups by the ratio of 3:1), blindness, and positive parallel control of Shuxuening Injection (SI), and multi-center clinical study. DGMI (25 mg, 5 mL/amp) or SI (5 mL/amp) was diluted into 250 mL physiological saline, iv drip, once daily for 14 d. The dropping speed must be controlled as 10-15 drops/min for the first infusion. Results: There was statistical difference (P=0.000 1) for the variations of inducing rate of the defect extent of nervous functions before and after the treatment in the experimental and control groups. The experimental group was superior to the control group. There was no statistical difference for the variation of scales of the patient living ability in the two groups (P>0.05). For the comprehensive efficacy of cerebral infarction, the total effective rates were 85.39% and 73.27% in the experimental and control groups, respectively, with statistical difference (P=0.0001). For the efficacy of syndrome of traditional Chinese medicine (TCM), the total effective rates were 62.99% and 40.59% in the experimental and control groups, respectively, with the statistical difference (P=0.0001). For the single indicator of nervous functions, such as arm movements, h and movements, extremity movements, walking, as well as the syndromes of TCM, such as upper limb disable, lower limb disable, deviated tongue, aphasia, abate or deficiency of feeling, dizziness, more and turbid phlegm, abnormal tongue and pulse manifestation, the experimental group was superior to the control group with statistified difference. Conclusion: It is safe and effective for DGMI in the treatment of the syndrome of stagnant phlegm blocking collaterals in convalescence of ATCI. Meanwhile, it is also manifested that DGMI has the certain superiorities in the fields, such as improving the total score of nervous function deficiency for the patients with stroke, the nervous function, the total score of TCM syndromes, including upper limb disable, deviated tongue, dizziness, more and turbid phlegm, white coat of tongue, abnormal pulse, etc.