[Translation] A randomized, double-blind, placebo-controlled, multicenter phase II-2 clinical study of Shenghuang Ketong ointment in the treatment of herpes zoster (liver meridian stagnation and heat syndrome)

在口服泛昔洛韦抗病毒治疗的基础上，以安慰剂软膏为对照，通过多中心、随机、双盲研究，客观评价升黄克痛软膏治疗带状疱疹的临床有效性和安全性，探索本品的临床治疗特色。

[Translation]

On the basis of oral famciclovir antiviral treatment, using placebo ointment as control, a multicenter, randomized, double-blind study was conducted to objectively evaluate the clinical efficacy and safety of Shenghuang Ketong Ointment in the treatment of herpes zoster and explore the clinical treatment characteristics of this product.

Start Date-

Sponsor / Collaborator

Chinese People's Liberation Army General Hospital

CTR20132056 / Active, not recruitingPhase 2IIT

升黄克痛软膏治疗肝经郁热证带状疱疹多中心、随机、单盲、阳性药平行对照Ⅱ期临床试验

[Translation] A multicenter, randomized, single-blind, positive drug parallel controlled phase II clinical trial of Shenghuang Ketong ointment in the treatment of herpes zoster with liver meridian stagnation and heat syndrome

以阿昔洛韦为对照，评价升黄克痛软膏治疗带状疱疹（肝经郁热证）的有效性和安全性，并进行剂量探索。

[Translation]

To evaluate the efficacy and safety of Shenghuang Ketong ointment in the treatment of herpes zoster (liver meridian stagnation and heat syndrome) with acyclovir as control, and to explore the dose.

Start Date15 Jul 2012

Sponsor / Collaborator

Chinese People's Liberation Army General Hospital

100 Clinical Results associated with Shenghuang Ketong Ointment

100 Translational Medicine associated with Shenghuang Ketong Ointment

100 Patents (Medical) associated with Shenghuang Ketong Ointment

Literatures (Medical) associated with Shenghuang Ketong Ointment

01 Aug 2021·PhytomedicineQ2 · MEDICINE

Traditional Chinese medicine shenhuang granule in patients with severe/critical COVID-19: A randomized controlled multicenter trial

Q2 · MEDICINE

Article

Author: Zhang, Wen ; Zhou, Shuang ; Wang, Junshuai ; Fan, Tian ; Che, Jinhua ; Fang, Bangjiang ; Yuan, Zuobiao ; Zou, Dengxiu ; Xie, Qin ; Feng, Jun ; Zhou, Daixing ; Huang, Tingrong ; Xu, Xiaoming ; Liu, Xudong ; Peng, Dan ; Yu, Gang ; Feng, Yikuan ; Zhan, Daqian ; Wu, Xinxin ; Sun, Shuting

BACKGROUNDCoronavirus disease 2019 (COVID-19) is still a pandemic, with a high mortality rate in severe/critical cases. Therapies based on the Shenghuang Granule have proved helpful in viral infection and septic shock.HYPOTHESIS/PURPOSEThe objective of the current study was to compare the efficacy and safety of the traditional Chinese medicine, Shenhuang Granule, with standard care in hospitalized patients with severe/critical COVID-19.STUDY DESIGN AND METHODSThis was an open-label, multicenter, randomized, controlled clinical trial. At 4 medical centers, a total of 111 severe/critical patients were randomly assigned to receive Shenhuang Granule (SHG group) twice a day for 14 days, in addition to standard care, or to receive standard care alone (Control group). The maximal follow up time was 75 days. The clinical endpoint was clinical improvement and mortality.RESULTS54 patients were assigned to the control group and 57 to the SHG group. The overall mortality was 75.9% (41/54) in the control group, and 38.6% (22/57) in the SHG group (p < 0.01 vs. control). The post hoc analysis showed that in the severe category, the mortality of the control group vs. the SHG group was 58.8% (10/17) vs. 5.3% (1/19) (p < 0.01); while in the critical category, it was 83.8% (31/37) vs. 55.3% (21/38) (p < 0.05). In the severe category, the mortality of patients who eventually received an invasive ventilator in the control vs. the SHG group was 58.8% (10/17) vs. 0 (0/19) (p < 0.01). Administration of SHG was associated with increased lymphocytes and decreased adverse events.CONCLUSIONShenhuang Granule is a promising integrative therapy for severe and critical COVID-19.

BMC Complementary Medicine and Therapies

Combination of Shengji ointment and bromelain in the treatment of exposed tendons in diabetic foot ulcers: study protocol for a non-blind, randomized, positive control clinical trial

Article

Author: Zhang, Zhaohui ; Sun, Xu ; Zhao, Yang ; Gao, Rui ; Dai, Xinyue ; Gao, Hongyang

AbstractBackgroundDiabetic foot ulcers often affect tendon tissue. Consequently, the infection may spread proximally along the tendon, leading to amputation or even the death of patients. Exposed, degenerated, and necrotic tendons are key factors affecting the healing of diabetic foot ulcers. The effective treatment of the tendon involvement may positively affect the prognosis. In clinical practice, treatment with Shengji ointment and bromelain induces islands of granulation tissue on the denatured tendon surface, which gradually grows and merges. Ideally, the exposed tendon is covered entirely by granulation tissue.This trial aims to assess the effect of a combined treatment regime of Shengji ointment, which has been shown to regenerate muscle tissue and pineapple protease in preventing the loss of function and amputation caused by tendon necrosis. This trial will provide high-quality evidence for the effectiveness of this combination in healing diabetic ulcers with tendon necrosis.MethodsThe sample size will be 180 patients who will be randomly assigned 1:1 to a treatment group (90 patients) using Shengji ointment combined with bromelain and a control group (90 patients) using hydrocolloid dressing. Both groups will continue their conventional treatments, such as blood glucose and blood pressure medication, lipid regulation, antiplatelets, and others. The primary outcome will be the wound coverage with granulation tissue. Secondary outcomes will be the wound healing rate, amputation extent (where needed), time to granulation, and the Maryland Foot Score. Other efficacy outcomes will be the time to debridement of necrotic tendon tissue and granulation tissue score.DiscussionThis study will treat patients with diabetic foot ulcers with exposed, degenerated, and necrotic tendons with Shengji ointment and bromelain. The trial aims to promote regeneration and healing, to preserve the limb and its function, and to develop a comprehensive and effective protocol that can be applied to promote the healing of exposed tendons in diabetic foot wounds.Trial registrationChiCTR2000039327; date of registration: 2020-10-23.

100 Deals associated with Shenghuang Ketong Ointment

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Indication	Highest Phase	Country/Location	Organization	Date
Herpes Zoster	Phase 2	CN	Chinese People's Liberation Army General Hospital	15 Jul 2012

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