A Double-blind, Placebo-controlled, Randomized, Parallel-group Study of the Safety and Effects of YisuiShengxueGranules on Thalassemia Presenting the Syndrome of Deficiency of Liver/Kidney-yin, and Asthenia of Essence/Blood.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2
- 主要终点
- Clinical effects on heamoglobin changes
研究概览
简要总结
The primary objectives of this study are to evaluate whether Yisui Shengxue Granules therapy can increase the hemoglobin level in peripheral blood and alleviate the symptoms, and at the same time, evaluate its safety in the treatment of Thalassemia with the syndrome of deficiency of liver-yin and kidney-yin, and asthenia of essence and blood.
详细描述
- INVESTIGATION PLAN 3.1 Study Design and Plan This study is a double-blind, placebo-controlled, randomized Parallel-group trial. Guang'anmen Hospital is the sponsor and has designed the clinical trial protocol. No.303 Hospital of Chinese People's Liberation Army (PLA) is the collaborator, where the most patients come from.
3.2 Random Method Using the randomized block design，stratifying by α-Thalassemia and β-Thalassemia, the patients will be allocated randomly 1:1 to Yisui Shengxue Granules group or placebo group.
Statistic Analysis System (SAS, SAS institute, Cary, NC, USA) was used to produce 001~120 random code, matching 120 subjects who divided randomly 1:1 into Yisui Shengxue Granules group and placebo group.
3.3 Blinding Design 3.3.1 Packaging of the study drug and placebo: all drugs including medical emergency envelops must be repackaged and reallocated according to regulations of standard double-blind clinical trial.
3.3.2．Blinding The encoded data will be kept in Guang'anmen Hospital, China Academy of Chinese Medical Sciences.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 3 Years 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Intermedia α-Thalassemia; intermedia β-Thalassemia; severe β-Thalassemia.
- •Syndrome of Deficiency of Liver-yin and Kidney-yin, and Asthenia of Essence and Blood.
- •Male or female, 3-40 years of age.
- •Provision of written informed consent.
排除标准
- •Complications with critical illness such as cerebrovascular disease, cardiovascular disease, hepatic disease, renal disease, malignancy and etc.
- •Allergy to any ingredients of Yisui Shengxue Granules
- •Psychiatric disorder.
- •Blood transfusion in the latest 90 days for severe β-Thalassemia; blood transfusion in the latest 45 days for intermediaβ-Thalassemia or intermedia α-Thalassemia.。
- •Upper respiratory tract infection with temperature higher than 38.5℃ in the latest 45 days.
- •Taking other antianemic agents in the latest 2 months.
- •Participation in any other clinical interventional trial in the latest 1 month.
研究组 & 干预措施
research
biological research on the effects of yisuishengxuegranule
干预措施: Yisuishengxue Granule (Drug)
clinical research
clinical research on thalassemia
干预措施: Yisuishengxue Granule (Drug)
结局指标
主要结局
Clinical effects on heamoglobin changes
时间窗: 6 months
Changes from Baseline in heamoglobins at 3and 6 months
次要结局
- Chinese Medicine syndrome improvment(6 months)
研究者
Wu Zhikui，Prof.
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Guang'anmen Hospital of China Academy of Chinese Medical Sciences