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Study of Effects of YisuiShengxueGranules on Thalassemia (thalessemia)

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ClinicalTrials.gov Identifier: NCT01549080
Recruitment Status : Completed
First Posted : March 8, 2012
Last Update Posted : March 8, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Thalassemia Drug: Yisuishengxue Granule

  Show Detailed Description

Study Design

Study Type : Observational
Actual Enrollment : 2 participants
Observational Model: Case Control
Time Perspective: Prospective
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 Asthenia of Essence/Blood.
Study Start Date : July 2011
Primary Completion Date : October 2011
Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Thalassemia
U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
research
biological research on the effects of yisuishengxuegranule
Drug: Yisuishengxue Granule
Yisui Shengxue Granules,produced by pharmaceutical factory of Guang'anmen Hospital, China Academy of Chinese Medical Sciences, is made from the herbs of Shan Zhu Yu (Fructus Corni), He Shou Wu (Radix Polygoni Multiflori), Shu Di Huang (Radix Rehmanniae Preparata), Huang Qi (Radix Astragali) and etc.Yisui Shengxue Granules:12g/bag, Registration Number:20110602; Yisui Shengxue Granules replacer (placebo):12g/bag,Registration Number:20110519;Treatment group:Yisui Shengxue Granules,1 bag, tid, po; Control group: Yisui Shengxue Granules replacer (placebo), 1 bag, tid, po; Intervention for 12 weeks. Follow-up 3 months later after stopping the drug intervention.
Other Name: Yisui Shengxue Granules replacer (placebo):
clinical research
clinical research on thalassemia
Drug: Yisuishengxue Granule
Yisui Shengxue Granules,produced by pharmaceutical factory of Guang'anmen Hospital, China Academy of Chinese Medical Sciences, is made from the herbs of Shan Zhu Yu (Fructus Corni), He Shou Wu (Radix Polygoni Multiflori), Shu Di Huang (Radix Rehmanniae Preparata), Huang Qi (Radix Astragali) and etc.Yisui Shengxue Granules:12g/bag, Registration Number:20110602; Yisui Shengxue Granules replacer (placebo):12g/bag,Registration Number:20110519;Treatment group:Yisui Shengxue Granules,1 bag, tid, po; Control group: Yisui Shengxue Granules replacer (placebo), 1 bag, tid, po; Intervention for 12 weeks. Follow-up 3 months later after stopping the drug intervention.
Other Name: Yisui Shengxue Granules replacer (placebo):


Outcome Measures

Primary Outcome Measures :
  1. Clinical effects on heamoglobin changes [ Time Frame: 6 months ]
    Changes from Baseline in heamoglobins at 3and 6 months


Secondary Outcome Measures :
  1. Chinese Medicine syndrome improvment [ Time Frame: 6 months ]
    changes from baseline in syndromes at 3 and 6 months


Biospecimen Retention:   Samples With DNA
Peripheral blood and bone marrow cells

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

The type of severe β-Thalassemia:Hb <60g/L, microcytic hypochromic anemia; more than 10% target erythrocyte and erythrocyte fragments; increased number of reticulocyte; more erythroblast in peripheral blood; extremely proliferative in marrow; HbF>30%~90%.

The type of intermedia β-Thalassemia:Hb 60g/L~100g/L; the shape of mature erythrocyte is similar to severe type; more reticulocyte; erythroblast may be found; HbF>3.5%.

The type of intermedia α-Thalassemia: The patients have mild or moderate anemia (Hemoglobin in a few patients is less than 60g/L or more than 100g/L),probably have hepatosplenomegaly, jaundice, and Mediterranean anemia features.

The Diagnosing Criteria for the Deficiency Syndrome of Liver-yin and Kidney-yin, and Asthenia of Essence and Blood in Chinese Medicine

Criteria

Inclusion Criteria:

  1. Intermedia α-Thalassemia; intermedia β-Thalassemia; severe β-Thalassemia.
  2. Syndrome of Deficiency of Liver-yin and Kidney-yin, and Asthenia of Essence and Blood.
  3. Male or female, 3-40 years of age.
  4. Provision of written informed consent.

Exclusion Criteria:

  1. Complications with critical illness such as cerebrovascular disease, cardiovascular disease, hepatic disease, renal disease, malignancy and etc.
  2. Allergy to any ingredients of Yisui Shengxue Granules
  3. Psychiatric disorder.
  4. 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.。
  5. Upper respiratory tract infection with temperature higher than 38.5℃ in the latest 45 days.
  6. Taking other antianemic agents in the latest 2 months.
  7. Participation in any other clinical interventional trial in the latest 1 month.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01549080


Sponsors and Collaborators
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Investigators
Principal Investigator: Wu zhikui, MD Guang'anmen Hospital of China Academy of Chinese Medical Sciences
More Information

Additional Information:
Responsible Party: Wu Zhikui,Prof., Guang'anmen Hospital of China Academy of Chinese Medical Sciences
ClinicalTrials.gov Identifier: NCT01549080     History of Changes
Other Study ID Numbers: 2011001P02/June 3rd, 2011
2010CB530406 ( Other Grant/Funding Number: Ministry of science and technology "973" project )
First Posted: March 8, 2012    Key Record Dates
Last Update Posted: March 8, 2012
Last Verified: June 2011

Keywords provided by Wu Zhikui,Prof., Guang'anmen Hospital of China Academy of Chinese Medical Sciences:
traditional chinese medicine and thalassemia

Additional relevant MeSH terms:
Thalassemia
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn