[Translation] A randomized, double-blind, low-dose controlled, multicenter, phase III clinical trial on the efficacy and safety of Xiaoer Biantong Granules in the treatment of childhood constipation (food accumulation syndrome)

评价小儿便通颗粒治疗小儿便秘（食积证）的有效性和安全性。

[Translation]

To evaluate the efficacy and safety of Xiaoer Biantong Granules in the treatment of constipation (food accumulation syndrome) in children.

Start Date19 Jun 2024

Sponsor / Collaborator

Nanjing Shenqu Pharmaceutical Technology Service Co., Ltd.

CTR20132075 / CompletedPhase 3

小儿便通颗粒治疗功能性便秘食积证评价其有效性和安全性的随机双盲、安慰剂平行对照、多中心、Ⅲ期临床研究

[Translation] A randomized, double-blind, placebo-controlled, multicenter, phase III clinical study to evaluate the efficacy and safety of Xiaoer Biantong Granules in the treatment of functional constipation and food accumulation syndrome

确证评价小儿便通颗粒对于儿童功能性便秘症状的缓解作用和食积证证候改善作用；确证评价小儿便通颗粒治疗功能性便秘食积证的安全性。

[Translation]

To confirm and evaluate the effect of Xiaoer Biantong Granules in alleviating the symptoms of functional constipation and improving the symptoms of food accumulation syndrome in children; to confirm and evaluate the safety of Xiaoer Biantong Granules in treating functional constipation and food accumulation syndrome.

Start Date24 Sep 2012

Sponsor / Collaborator

Nanjing Shenqu Pharmaceutical Technology Service Co., Ltd.

CTR20130641 / CompletedPhase 2

小儿便通颗粒治疗功能性便秘食积证评价其有效性和安全性的随机双盲、安慰剂平行对照、多中心临床研究

[Translation] A randomized, double-blind, placebo-controlled, multicenter clinical study to evaluate the efficacy and safety of Xiaoer Biantong Granules in the treatment of functional constipation and food accumulation syndrome

探索小儿便通颗粒治疗功能性便秘食积证的有效性和安全性。

[Translation]

To explore the effectiveness and safety of Xiaoer Biantong Granules in the treatment of functional constipation and food accumulation syndrome.

Start Date31 Dec 2010

Sponsor / Collaborator

Nanjing Shenqu Pharmaceutical Technology Service Co., Ltd.

100 Clinical Results associated with Xiaoer Biantong Granules

100 Translational Medicine associated with Xiaoer Biantong Granules

100 Patents (Medical) associated with Xiaoer Biantong Granules

Literatures (Medical) associated with Xiaoer Biantong Granules

01 Jan 2018·Evidence-Based Complementary and Alternative MedicineQ4 · MEDICINE

Corrigendum to “A Randomized Controlled Trial of Chinese Patent Medicine Xiao’er Biantong Granules in the Treatment of Functional Constipation in Children”

Q4 · MEDICINE

ArticleOA

Author: He, Ping ; Yang, Na ; Ma, Rong ; Xiang, Xi-Xiong ; Ding, Ying ; Li, Xin-Min ; Han, Xin-Min ; Chang, Ke ; Wang, Xue-Feng ; Xue, Zheng ; Cai, Qiu-Han ; Zhang, Wei ; Zhong, Cheng-Liang ; Hu, Si-Yuan

[This corrects the article DOI: 10.1155/2018/4941505.].

01 Jan 2018·Evidence-Based Complementary and Alternative MedicineQ4 · MEDICINE

A Randomized Controlled Trial of Chinese Patent Medicine Xiao’er Biantong Granules in the Treatment of Functional Constipation in Children

Q4 · MEDICINE

ArticleOA

Author: He, Ping ; Yang, Na ; Xiang, Xi-Xiong ; Ma, Rong ; Ding, Ying ; Li, Xin-Min ; Han, Xin-Min ; Wang, Xue-Feng ; Xue, Zheng ; Chang, Ke ; Cai, Qiu-Han ; Zhang, Wei ; Zhong, Cheng-Liang ; Hu, Si-Yuan

Objective. To confirm the effect and safety of Xiao’er Biantong (XEBT) granules for treating chronic constipation in children. Methods. This randomized, double‐blind, multicenter study enrolled 480 children with age of 1–14 years who had FC. All of them were randomly assigned to receive either XEBT granules or its placebo in the ratio of 3 : 1. The primary efficacy outcome was the frequency of spontaneous bowel movements (SBM) for 14 days, and secondary outcomes were effectual time, score of main symptoms, effect of constipation, disappearance rate of accompanying symptoms, and recurrence rate. We also observed the adverse event (AE) and adverse drug reaction (ADR) to evaluate safety. Results. The sociodemographic characteristics and efficiency data were comparable in the two groups at baseline. The mean values of SBM for 14 days were 8.89 and 5.63 in the XEBT group and the placebo group, respectively, and there were 86.87% and 30.91% subjects in two groups up to SBM ≥ 3/week, respectively. There were significant differences between the two groups. The effects in the XEBT group on median effectual time of defecation, main symptom score, disappearance rate of symptoms, and the differences were significant. The conclusions based on full analysis set (FAS) and per protocol set (PPS) were consistent. Nine AEs were reported, of which 7 were in the XEBT group (2.02%) while 2 were in the placebo group (1.77%). There were no significant differences in the occurrence rate of AE and ADR between the two groups. Conclusions. Xiao’er Biantong granules have superior efficacy compared to the placebo for the treatment of functional constipation in children and are well tolerated.

100 Deals associated with Xiaoer Biantong Granules

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Constipation - functional	Phase 2	CN	Nanjing Shenqu Pharmaceutical Technology Service Co., Ltd.	24 Sep 2012

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