[Translation] A randomized, double-blind, placebo-controlled, multicenter clinical trial to evaluate the short-term efficacy and safety of Huanglong Granule in children with attention deficit hyperactivity disorder (Yin deficiency and Yang hyperactivity syndrome).

1.进一步验证小儿黄龙颗粒用于注意缺陷多动障碍（阴虚阳亢证）儿童6周的疗效，探索小儿黄龙颗粒用于注意缺陷多动障碍（阴虚阳亢证）儿童8周的疗效，综合评估其临床价值； 2.进一步验证小儿黄龙颗粒用于注意缺陷多动障碍（阴虚阳亢证）儿童的安全性。

[Translation]

1. Further verify the efficacy of Huanglong Granules for children with attention deficit hyperactivity disorder (Yin deficiency and Yang hyperactivity syndrome) for 6 weeks, explore the efficacy of Huanglong Granules for children with attention deficit hyperactivity disorder (Yin deficiency and Yang hyperactivity syndrome) for 8 weeks, and comprehensively evaluate its clinical value; 2. Further verify the safety of Huanglong Granules for children with attention deficit hyperactivity disorder (Yin deficiency and Yang hyperactivity syndrome).

Start Date-

Sponsor / Collaborator

Chongqing Hilan Pharmaceutical Co., Ltd.

CTR20160582 / RecruitingPhase 4

小儿黄龙颗粒治疗儿童注意缺陷多动障碍评价其安全性和有效性的单臂、多中心Ⅳ期临床研究

[Translation] A single-arm, multicenter phase IV clinical study to evaluate the safety and efficacy of Huanglong Granule in the treatment of children with attention deficit hyperactivity disorder

试验目的：观察在广泛应用条件下（1）观察小儿黄龙颗粒单独应用或与西药联合应用的安全性和有效性。（2）观察辨证用药与辨病用药的有效性和安全性。（3）观察扩大年龄范围至4～17岁的有效性和安全性。（4）观察合并抽动障碍的有效性。（5）观察长期治疗的安全性与有效性。

[Translation]

Purpose of the trial: To observe the safety and effectiveness of Huanglong Granule for children alone or in combination with western medicine under a wide range of application conditions. (1) To observe the effectiveness and safety of Huanglong Granule for children alone or in combination with western medicine. (2) To observe the effectiveness and safety of medication based on syndrome differentiation and medication based on disease differentiation. (3) To observe the effectiveness and safety of expanding the age range to 4 to 17 years old. (4) To observe the effectiveness of combined tic disorders. (5) To observe the safety and effectiveness of long-term treatment.

Start Date04 Jul 2016

Sponsor / Collaborator

Chongqing Hilan Pharmaceutical Co., Ltd.

100 Clinical Results associated with Xiaoer Huanglong Granules

100 Translational Medicine associated with Xiaoer Huanglong Granules

100 Patents (Medical) associated with Xiaoer Huanglong Granules

Literatures (Medical) associated with Xiaoer Huanglong Granules

01 Aug 2022·Journal of Separation Science

Phytochemical identification of Xiaoer Huanglong Granule and pharmacokinetic study in the rat using its seven major bioactive components

Article

Author: Sai, Na ; Yang, Chunjing ; Wu, Huimin ; Yin, Xingbin ; You, Longtai ; Peng, Hulinyue ; Ni, Jian ; Sun, Mingyi ; Liang, Xiao ; Liu, Jing ; Cai, Mengru

Xiaoer Huanglong Granule is the only Chinese Patent Medicine widely used for treating attention deficit hyperactivity disorder. However, not much is known about the bioactive components and pharmacokinetics of Xiaoer Huanglong Granule even after it was successfully introduced into clinical use. This study analyzed the components in the medication and rat plasma after oral administration with the help of the UNIFI platform and Masslynx. A total of 119 and 37 components were detected in the medication and plasma, respectively, using an ultra‐performance liquid chromatography‐tandem mass spectrometer. We established a rapid and sensitive simultaneous determination of one triterpene saponin, three monoterpene glycosides, and three lignans in rat plasma by solid‐phase extraction. The determination was accomplished within 7.50 min via gradient elution. The values of the lower limit of quantitation were validated at 0.08 ng/ml for tenuifolin, 0.8 ng/ml for lactiflorin, 1.828 ng/ml for albiflorin, 2 ng/ml for paeoniflorin, gomisin B, and gomisin D, 10 ng/ml for schisandrin. The results from validations of other methods were all acceptable (relative standard deviation ≤ 14.94%). This is the first report on the identification and pharmacokinetics studies of components in Xiaoer Huanglong Granule. Moreover, the pharmacokinetic behavior of lactiflorin was studied for the first time.

100 Deals associated with Xiaoer Huanglong Granules

R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Attention Deficit Disorder With Hyperactivity	CN	Chongqing Hilan Pharmaceutical Co., Ltd.	24 May 2019

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