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Randomized, Double-blind, Placebo-controlled, Multicenter Phase IIb Clinical Trial of Spray YJ001 for the Treatment of Diabetic Peripheral Neuropathic Pain

Zhejiang Yuejia Pharmaceuticals Co., Ltd. · 2024
ClinicalTrials.gov · Datasets · License: Public Domain · 2024
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The goal of this clinical trial is to learn if YJ001 Spray can treat diabetic patients with Diabetic Peripheral Neuropathic Pain(DPNP). The main questions it aims to answer are: * Is YJ001 spray effective for patients with diabetic peripheral neuropathic pain(DPNP)? * The optimal effective dose of YJ001 spray for patients with diabetic peripheral neuropathic pain(DPNP). * Is YJ001 spray safe for patients with diabetic peripheral neuropathic pain(DPNP)? Researchers will divide YJ001 spray into three different doses of YJ001 spray and compare it with a placebo (a substance that looks similar but does not contain medication) to observe whether YJ001 spray can effectively treat diabetic peripheral neuropathic pain and to determine the optimal effective dose. Participants will: * Apply spray topically to both feet twice daily, with six sprays per foot at each administration.Attend scheduled study visits at baseline and weeks 1, 2, 4, 8, and 12, followed by a visit 1 week after Treatment termination. * Record their symptoms and the number of times they use the spray.
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