[Translation] Phase II clinical trial of 6 types of traditional Chinese medicine Huadan Anshen mixture--A randomized, double-blind, placebo-controlled, multicenter clinical trial of Huadan Anshen mixture in the treatment of insomnia

主要目的：评价花丹安神合剂治疗失眠症的疗效，并与安慰剂比较。次要目的：评价花丹安神合计治疗失眠症的安全性；观察停用花丹安神合剂后的反跳性失眠。

[Translation]

Primary purpose: To evaluate the efficacy of Huadan Anshen Mixture in the treatment of insomnia and compare it with placebo. Secondary purpose: To evaluate the safety of Huadan Anshen Mixture in the treatment of insomnia; to observe rebound insomnia after discontinuation of Huadan Anshen Mixture.

Start Date22 Mar 2006

Sponsor / Collaborator

Shanghai Traditional Chinese Medicine Hospital

100 Clinical Results associated with Huadan Anshen Mixture

100 Translational Medicine associated with Huadan Anshen Mixture

100 Patents (Medical) associated with Huadan Anshen Mixture

Literatures (Medical) associated with Huadan Anshen Mixture

01 Mar 2019·Zhongguo Zhong yao za zhi = Zhongguo zhongyao zazhi = China journal of Chinese materia medica

[Clinical efficacy of Bushen Huoxue Anshen therapy in treating perimenopausal sleep disorder with kidney deficiency and blood stasis].

Article

Author: Ma, Kun ; Dong, Mei-Ling ; Chen, Yan-Xia

The efficacy and safety of traditional Chinese medicine and acupuncture in the treatment of kidney-deficiency and bloodstasis perimenopausal sleep disorders were evaluated. A total of 67 subjects who completed the study were randomly divided into two groups. The traditional Chinese medicine group was orally given Bushen Huoxue Anshen Fang,and the acupuncture group was given acupuncture treatment. Both groups were treated for three consecutive courses of treatment,with a course of treatment of 30 days. The changes of PSQI score,improved Kupperman score,TCM syndromes,serum sex hormone,coagulation,routine blood and urine,liver and kidney function and electrocardiogram were observed before and after treatment. After treatment,the total effective rates of Chinese medicine group and acupuncture group were similar or respectively 91. 43% and 87. 50%. The scores of PSQI,improved Kupperman and TCM syndromes in both groups decreased significantly( P<0. 05). The effect of improving Kupperman score in TCM group was better than that in acupuncture group( P< 0. 01). The effect of improving PSQI and TCM syndromes was similar to that in acupuncture group. The levels of serum FSH and LH were decreased in both groups( P<0. 05),but with no significant difference between the two groups; the level of serum E2 was increased in both groups,but with no significant difference. Compared with before treatment,PT was increased in traditional Chinese medicine group( P<0. 05),but with no significant difference in APTT,TT and FIB before and after treatment; PT and TT were prolonged in acupuncture group( P<0. 05),but with no significant difference in APTT and FIB before and after treatment. The effect of improving PT and TT in the acupuncture group was better than that in the traditional Chinese medicine group( P<0. 05). The results showed that TCM and acupuncture had similar therapeutic effects on perimenopausal sleep disorder of kidney deficiency and blood stasis type,and were safe and reliable. The mechanism was related to the improvement of serum FSH and E2 levels.

01 Aug 2013·Journal of Traditional Chinese MedicineQ4 · MEDICINE

Efficacy of HuaDan Anshen Mistura for treating insomnia: a randomized, double-blind, placebo-controlled, multi-center clinical trial

Q4 · MEDICINE

Article

Author: Xiaoli Yan ; Ting Li ; Jian Xu ; Huafang Li ; Yifeng Xu ; Qiaochu Wang

OBJECTIVETo evaluate the effect of Huadananshen mistura in clinical treatment of Chinese patients with insomnia.METHODSIn this randomized, double-blind, placebo-controlled, multi-center study, 244 patients with insomnia were randomly assigned to a placebo group, a low-dose (10 mL/day), or a high-dose (20 mL/day) mistura group. Efficacy was assessed by using the sleep dysfunction rating scale (SDRS) and Clinical Global Impression-Improvement (CGI-I) scores. Safety and tolerability assessments included emergent adverse events, laboratory tests, and electrocardiograms.RESULTSTotal SDRS scores decreased in all three groups, and there were significant differences between the placebo group and the low- and high-dose mistura (P = 0.000). CGI-I ratings in the low- and high-dose mistura groups were significantly better than that of the placebo group (P = 0.000). Incidences of rebound insomnia were similar in all three groups (placebo group: 6.94%, low-dose mistura group: 12.99%, and high-dose mistura group: 10.96%; P = 0.475). The efficacy of Huadananshen mistura in the low- or high-dose group was significantly better than that of the placebo group (P = 0.000), but with no significant difference found between the low- and high-dose mistura groups (P = 0.887). The rates of adverse events were similar in the three groups (placebo 2.44%, low-dose mistura 0%, and high-dose mistura 5%; P = 0.088).CONCLUSIONHuadananshen mistura is an effective and generally well-tolerated hypnotic medicine for the treatment of Chinese patients with insomnia.

01 Feb 2000·Zhonghua er bi yan hou ke za zhi

[Acoustic analysis and characteristics of vocal range in Beijing Opera actors].

Article

Author: Qu, C ; Liu, Y

OBJECTIVETo get the objective acoustic parameters of the voice of Beijing Opera actors and set a foundation for the training and protection of the special professional voice.METHODSSeventy-three (age 16-57 years) professional actors and students were asked to produce sustained comfortable vowels /a/ and /i/, and to sing two pieces of songs which were in the category of Xipi and Erhuang respectively. Dr. Speech for windows version 3.0 was used to get the acoustic parameters of the vowels and the songs.RESULTSF0 of the vowels /a/ and /i/ of different Hangdangs were Chou (272.6 +/- 42.0) Hz (mean +/- s), (304.2 +/- 22.1) Hz; Xiaosheng (499.3 +/- 34.0) Hz, (485.4 +/- 18.7) Hz; Laosheng (335.6 +/- 60.0) Hz, (317.9 +/- 45.1) Hz; Hualian (319.0 +/- 61.3) Hz, (340.1 +/- 68.8) Hz; Laodan (427.6 +/- 47.2) Hz, (437.7 +/- 45.8) Hz; Huadan (535.8 +/- 48.8) Hz, (561.6 +/- 29.2) Hz; Qingyi (548.0 +/- 69.5) Hz, (543.5 +/- 79.3) Hz; these and other acoustic parameters of vowels such as Jitter, Shimmer and NNE were all within the normal range given by the software. The vocal range of Beijing Opera actors was from 1.7 to 2.8 oct, and most of the highest and the lowest pitches were higher than that of tenor or soprano.CONCLUSIONSThese findings may help to provide insight regarding the acoustic characteristics of the voice of Beijing Opera actors.

100 Deals associated with Huadan Anshen Mixture

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Indication	Highest Phase	Country/Location	Organization	Date
Sleep Initiation and Maintenance Disorders	Phase 2	CN	Shanghai Traditional Chinese Medicine Hospital	22 Mar 2006

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