Clinical Trial: Study of Effects of YisuiShengxueGranules on Thalassemia
Study Status: Completed
Recruit Status: Completed
Study Type: Observational
Official Title: 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
Brief Summary: 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.
Detailed Summary:
3. 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.
When all patients fulfill the procedures of the trial, the data will be entered into electronic Case Report Forms (eCRFs) and locked, and then the blind will be disclosed.
If unmasking is necessary because of a serious, unexpected and related adverse event or if a medical emergency occurs which requires knowledge of the exact therapy, the investigator may contact the principal investigator or censor to determine whether the medical emergency envelop will be broken. The date and reason of the code breaking must be documented and signed and this information must be sent t
Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Current Primary Outcome: Clinical effects on heamoglobin changes [ Time Frame: 6 months ]
Original Primary Outcome: Clinical effects,Chinese Medicine syndrome improvment [ Time Frame: 9 months ]
Effective significantly:
Effective:
Ineffective:
Current Secondary Outcome: Chinese Medicine syndrome improvment [ Time Frame: 6 months ]
Original Secondary Outcome:
Information By: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Dates:
Date Received: February 27, 2012
Date Started: July 2011
Date Completion:
Last Updated: March 7, 2012
Last Verified: June 2011
