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Journal of Chinese Integrative Medicine ›› 2011, Vol. 9 ›› Issue (11): 1199-1205.doi: 10.3736/jcim20111107

• Study Protocol • Previous Articles     Next Articles

Study protocol for a self-controlled case study to evaluate the safety and standardization for external application of Chinese medicine Jiuyi Powder

Mei-na Ye1, Hong-feng Chen()1, Yi-qin Cheng1, Yan-sheng Zhang2, Ping Li3, Gang Gui4, Li-ying Chen1, Hao Chen1, Hong-yu Dai2   

  1. 1. Department of Breast Surgery, Longhua Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai 200032, China
    2. Department of Traditional Chinese Surgery, Dongfang Hospital, Beijing University of Chinese Medicine, Beijing 100078, China
    3. Department of Traditional Chinese Surgery, Shanghai Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai 200071, China
    4. Department of Traditional Chinese Surgery, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai 200011, China
  • Received:2011-08-14 Accepted:2011-09-12 Online:2011-11-20 Published:2011-11-15

Background: As the main medicinal powder for drawing out pus and removing necrotic tissue in external therapies of traditional Chinese surgery, Sheng Powder has made great contributions to the treatment of inflammatory wounds and has the unique bactericidal and decay-discharging function that can not be replaced by antibiotics. However, Sheng Powder has toxicity because it contains mercury. So far, there is no clinical research on the standards of dose and usage of Sheng Powder and there is a lack of objective and quantitative criteria for operating standards and monitoring of toxicity and side effects. Therefore, the authors choose Jiuyi Powder, one of the most commonly used Sheng Powder, to evaluate the safety of its external use, and form a standardization program for clinical implementation.
Methods and design: This study is a nonrandomized, nonblinded, self-controlled case study. There will be two key stages in the study. In stage one, 10 patients with plasma cell mastitis will be enrolled. The patients will receive continuous external application of Jiuyi Powder with a fixed dose (160 mg/d). Blood mercury and urine mercury levels will be dynamically tested at different time intervals, and the observation of pharmacokinetic parameters will be conducted after Jiuyi Powder has been absorbed by the surface of the wound. In stage two, 30 patients with each of the four conditions including postoperative wounds of head or facial surgeries, plasma cell mastitis, anal fistula and chronic absorption ulcer of the shank will be enrolled, respectively. According to the dose of 1.5 mg/cm 2, Jiuyi Powder will be externally applied to the wound surface for 14 d. On the basis of the first-phase study, the test time will be chosen and the toxicity outcome will be detected to evaluate the safety of external application of Jiuyi Powder and to establish recommendations for standardized clinical use.
Discussion: The purpose of this study is to evaluate the safety of the external application of Jiuyi Powder through a two-stage study. The pharmacokinetic parameters of external application of Jiuyi Powder at the clinical dose range, the changes in blood and urinary mercury levels and related safety indexes will be observed on different wounds located in different positions externally. The evaluation of whether Jiuyi Powder could be a routine medication for drawing out pus and removing necrotic tissue in inflammatory and refractory wounds will be stated.
Trial registration number: ChiCTR-TNC-11001366.

Key words: Jiu-yi powder, safety, standardization, external therapy

Figure 1

Flow chart of this trial"

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