[Translation] Using placebo as control, through a multicenter, randomized, double-blind study, objectively evaluate the clinical efficacy and safety of anti-rash and analgesic gel in the treatment of herpes zoster to explore clinical research

以安慰剂为对照，探索不同剂量组消疹止痛凝胶治疗带状疱疹（肝经湿热证）的有效性及安全性。

[Translation]

Using placebo as control, explore the efficacy and safety of different doses of anti-rash and analgesic gel in the treatment of herpes zoster (liver meridian damp-heat syndrome).

Start Date15 Dec 2020

Sponsor / Collaborator

Suzhou Youseen New Drug R&D Co. Ltd.

[+1]

100 Clinical Results associated with Xiaozhen Zhitong Gelatum

100 Translational Medicine associated with Xiaozhen Zhitong Gelatum

100 Patents (Medical) associated with Xiaozhen Zhitong Gelatum

Literatures (Medical) associated with Xiaozhen Zhitong Gelatum

28 Feb 2024·Zhong nan da xue xue bao. Yi xue ban = Journal of Central South University. Medical sciences

Clinical efficacy of Zhiyang Xiaozhen granules combined with second-generation antihistamine in the treatment of chronic urticaria.

Article

Author: Zhang, Li ; Cao, Qiaozhi ; Li, Jie ; Chen, Xiang ; Peng, Cong ; Chen, Mingliang ; Yang, Bo ; Su, Juan

OBJECTIVESChronic urticaria presents a chronic process of recurrent attacks, and its first-line treatment is second-generation antihistamine with limited treatment options. The efficacy of antihistamine varies among individuals and cannot meet the needs of all patients. This study aims to explore the clinical efficacy and safety of Zhiyang Xiaozhen granules combined with antihistamine in the treatment of chronic urticaria patients.METHODSWe retrospectively analyzed the clinical data of patients with chronic urticaria who visited the Xiangya Hospital of Central South University from April 2020 to March 2021. The patients who received conventional second-generation antihistamine treatment were selected as a control group, while the patients who received combined treatment with Zhiyang Xiaozhen granules on the basis of conventional second-generation antihistamine treatment were selected as an observation group. The differences in the Weekly Urticaria Activity Score (UAS7) and Dermatology Life Quality Index (DLQI) between the 2 groups before and 4 weeks after treatment were compared. The Symptom Score Reduce Index (SSRI) was used to evaluate and compare the efficacy of the 2 treatment regimens.RESULTSAfter 4 weeks of treatment, the UAS7 levels in both groups were significantly reduced (P=0.001 and P<0.001, respectively). The effective rates of the control group and the observation group were 61.11% and 59.38%, respectively when converting UAS7 to SSRI for efficacy evaluation, and there was no statistically significant difference in efficacy between the 2 groups (P>0.05); however, when converting DLQI to SSRI for efficacy evaluation, the effective rates of the control group and the observation group were 33.33% and 46.88%, respectively, and the difference in efficacy between the 2 groups was statistically significant (P<0.001). There were 3 patients with adverse drug reactions related to drowsiness in both groups.CONCLUSIONSThe combination of Zhiyang Xiaozhen granules and second-generation antihistamine can effectively improve disease activity in patients with chronic urticaria, and the improvement in quality of life is better than that with the second-generation antihistamine alone.

01 Nov 2022·Journal of Ethnopharmacology

Integrating pharmacokinetics and network pharmacology to identify and validate targets of Guben Xiaozhen prescription for the treatment of chronic urticaria

Article

Author: Wang, Yang ; Wu, Yayun ; Lu, Chuanjian ; Zhao, Ruizhi ; Ren, Yuanxin ; Zhao, Ya ; Liu, Lijuan

ETHNOPHARMACOLOGICAL RELEVANCEGuben Xiaozhen prescription (GXP), a prescription of traditional Chinese medicine, has been used to treat skin diseases for a long history and achieved satisfactory therapeutic effects. However, its active ingredients and targets remain to be further elucidated.AIM OF THIS STUDYIdentify activity ingredients of GXP for the treatment of chronic urticaria (CU) and further validate the efficacy and targets of the selected component.MATERIALS AND METHODSFirstly, the pharmacokinetics of different disassemble groups of GXP was investigated to screen for active ingredients with improved bioavailability. Then, shared targets between active ingredients and CU were performed by network pharmacology. Finally, the ovalbumin (OVA) induced CU model was used to verify the efficacy and targets of the screened active ingredient.RESULTSPharmacokinetic results showed that, compared with sub-division groups, the maximum concentration (C_max) and blood concentration-time curve (AUC_0-t) of eight ingredients, including 6-shogaol, 6-gingerol, calycosin, dictamnine, fraxinellone, schizandrin, cimifugin, and sec-o-glucosylhamaudol were increased in the GXP group. Then, 218 CU-related targets and 20 shared targets with six potential active compounds were screened by network pharmacology. Further analysis found that fraxinellone was not reported to be associated with CU in the literature. Therefore, the present study employed an OVA-induced CU model and found that fraxinellone could dose-dependently inhibit the locus coeruleus reaction, mast cell degranulation, and pathological skin damage. Moreover, we further verified the ADRB2 and its downstream target caspase3 predicted by network pharmacology, and fraxinellone inhibited the expression of ADRB2 and caspase3 in high dose group, suggesting that fraxinellone may play an anti-CU role by inhibiting inflammation and cell apoptosis.CONCLUSIONIn this study, integrated pharmacokinetics and network pharmacology methods were established to screen out six effective active ingredients in GXP for the treatment of CU. This study provides a new idea for screening active substances in traditional Chinese medicine.

01 Jan 2020·Evidence-Based Complementary and Alternative Medicine

Retracted: Topical Treatment with Xiaozheng Zhitong Paste (XZP) Alleviates Bone Destruction and Bone Cancer Pain in a Rat Model of Prostate Cancer‐Induced Bone Pain by Modulating the RANKL/RANK/OPG Signaling

Author: and Alternative Medicine, Evidence-Based Complementary

[This retracts the article DOI: 10.1155/2015/215892.].

100 Deals associated with Xiaozhen Zhitong Gelatum

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Indication	Highest Phase	Country/Location	Organization	Date
Herpes Zoster	Phase 2	CN	Jining Huaneng Pharmaceutical Factory Co., Ltd	15 Dec 2020
Herpes Zoster	Phase 2	CN	Suzhou Youseen New Drug R&D Co. Ltd.	15 Dec 2020

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