Core Viewpoint - Hunan Fangsheng Pharmaceutical Co., Ltd. announced the completion of the Phase II clinical trial report for its innovative traditional Chinese medicine, Zhilong Tongluo Tablets, which is aimed at treating ischemic stroke recovery [1][2]. Group 1: Basic Information - Drug Name: Zhilong Tongluo Tablets - Dosage Form: Tablets - Research Type: Phase II Clinical Trial - Clinical Approval Number: 2011L01961 - Clinical Approval Date: November 5, 2011 - Cumulative R&D Expenditure: Approximately 13.566 million RMB (unaudited) [1]. - Indication: Aims to invigorate qi and blood, dispel stasis, and is suitable for treating symptoms related to ischemic stroke recovery [1]. Group 2: Clinical Research Details - The clinical trial was conducted at seven national drug clinical trial institutions across various provinces, with a total of 240 planned participants, of which 214 were actually enrolled [2][3]. - The trial design was randomized, double-blind, and included a placebo control, with participants divided into high-dose (7.5g/day), low-dose (4.5g/day), and placebo groups, receiving treatment for 12 weeks [3]. Group 3: Clinical Research Results - Efficacy results indicated that both high and low doses of Zhilong Tongluo Tablets showed better outcomes compared to the placebo in terms of the Modified Rankin Scale, NIHSS score changes, and quality of life measures [4]. - Safety results showed no significant differences in severe adverse events among groups, with all serious adverse events related to acute stroke recurrence, indicating good safety [4]. - The low-dose group is recommended to proceed to Phase III clinical research due to comparable efficacy with the high-dose group [4]. Group 4: Market Situation - Zhilong Tongluo Tablets are classified as a Class 1 innovative traditional Chinese medicine and are currently the company's exclusive product, with no other companies having obtained production approval for this product [5]. - Other traditional Chinese medicines for treating ischemic stroke include various products with significant sales figures, indicating a competitive market landscape [5].
湖南方盛制药股份有限公司 关于蛭龙通络片获得II期临床试验总结报告的公告