Efficacy of Gastrosis No.1 compound on functional dyspepsia of spleen and stomach deficiency-cold syndrome: A multi-center, double-blind, placebo-controlled clinical trial

Sheng-sheng Zhang; Lu-qing Zhao; Hong-bing Wang; Bing Wu; Chui-jie Wang; Sui-ping Huang; Hong Shen; Wei Wei; Yao-liang Lai

doi:10.1007/s11655-013-1503-x

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Efficacy of Gastrosis No.1 compound on functional dyspepsia of spleen and stomach deficiency-cold syndrome: A multi-center, double-blind, placebo-controlled clinical trial

Updated：2021-08-27

- Efficacy of Gastrosis No.1 compound on functional dyspepsia of spleen and stomach deficiency-cold syndrome: A multi-center, double-blind, placebo-controlled clinical trial
- Chinese Journal of Integrative Medicine Vol. 19, Issue 7, Pages: 498-504(2013)
- Affiliations：
  
  1. Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University,Beijing,China
  2. The Affiliated Hospital of Liaoning University of Traditional Chinese Medicine,Shenyang,China
  3. The Second Affiliated Hospital of Guangdong University of Traditional Chinese Medicine,Guangzhou,China
  4. The Affiliated Hospital of Nanjing University of Traditional Chinese Medicine,Nanjing,China
  5. Wangjing Hospital, China Academy of Chinese Medical Sciences,Beijing,China
  6. Beijing Xuanwu Hospital of Traditional Chinese Medicine,Beijing,China
- Author bio：
- Funds：
  
  Supported by the Eleventh Five-Year National Key Technology R&D Program (No. 2007BAI20B092)
- DOI：10.1007/s11655-013-1503-x
  CLC：
- Published：2013，
  
  Published Online：2 July 2013，
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Zhang, Ss., Zhao, Lq., Wang, Hb. et al. Efficacy of Gastrosis No.1 compound on functional dyspepsia of spleen and stomach deficiency-cold syndrome: A multi-center, double-blind, placebo-controlled clinical trial., Chin. J. Integr. Med. 19, 498–504 (2013). https://doi.org/10.1007/s11655-013-1503-x

Sheng-sheng Zhang, Lu-qing Zhao, Hong-bing Wang, et al. Efficacy of Gastrosis No.1 compound on functional dyspepsia of spleen and stomach deficiency-cold syndrome: A multi-center, double-blind, placebo-controlled clinical trial. [J]. Chinese Journal of Integrative Medicine 19(7):498-504(2013)
Zhang, Ss., Zhao, Lq., Wang, Hb. et al. Efficacy of Gastrosis No.1 compound on functional dyspepsia of spleen and stomach deficiency-cold syndrome: A multi-center, double-blind, placebo-controlled clinical trial., Chin. J. Integr. Med. 19, 498–504 (2013). https://doi.org/10.1007/s11655-013-1503-x DOI：

Sheng-sheng Zhang, Lu-qing Zhao, Hong-bing Wang, et al. Efficacy of Gastrosis No.1 compound on functional dyspepsia of spleen and stomach deficiency-cold syndrome: A multi-center, double-blind, placebo-controlled clinical trial. [J]. Chinese Journal of Integrative Medicine 19(7):498-504(2013) DOI： 10.1007/s11655-013-1503-x.

摘要

To assess the efficacy and safety of Gastrosis No.1 compound in the treatment of functional dyspepsia with Spleen (Pi) and Stomach (Wei) deficiency-cold syndrome. A randomized

double-blind

placebo-controlled trial was performed in 5 centers. Patients with functional dyspepsia (FD) of Spleen-deficiency and qi-stagnation syndrome (162 cases) were randomly assigned to groups given Chinese herbal medicine (CHM) Gastrosis No.1 compound or placebo in a 2:1 ratio. This trial included a 4-week treatment period and a 4-week follow-up period. The outcomes were the dyspepsia symptom scores (measured by total dyspepsia symptom scale and single dyspepsia symptom scale) and syndromes of traditional Chinese medicine score (measured by traditional Chinese medicine syndrome scale). The outcomes were noted at weeks 0

4 and 8. Compared with patients in the placebo group

patients in the CHM group showed significant improvement in the dyspepsia symptom scores as rated by patients and investigators (P <0.01)

and also showed improvement in syndromes of traditional Chinese medicine score (P <0.01). No serious adverse event was reported. Safety tests obtained after 4 weeks of treatment showed no abnormal values. CHM Gastrosis No.1 compound was effective and safe in the treatment of functional dyspepsia with Spleen and Stomach deficiency-cold syndrome

Abstract

To assess the efficacy and safety of Gastrosis No.1 compound in the treatment of functional dyspepsia with Spleen (Pi) and Stomach (Wei) deficiency-cold syndrome. A randomized

double-blind

4 and 8. Compared with patients in the placebo group

patients in the CHM group showed significant improvement in the dyspepsia symptom scores as rated by patients and investigators (P <0.01)

关键词

functional dyspepsiaSpleen and Stomach deficiency-cold syndromerandomized controlled trial

Keywords

functional dyspepsiaSpleen and Stomach deficiency-cold syndromerandomized controlled trial

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Department of Medical Statistics, School of Public Health, Sun Yat-sen University

Gastroenterology Department, the First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine

Postgraduate Department, Guangzhou University of Traditional Chinese Medicine

Institute of Traditional Chinese Medicine, Tianjin University of Traditional Chinese Medicine

First Hospital Affiliated to Tianjin University of Traditional Chinese Medicine

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