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Study of Effects of YisuiShengxueGranules on Thalassemia (thalessemia)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Wu Zhikui，Prof., Guang'anmen Hospital of China Academy of Chinese Medical Sciences
ClinicalTrials.gov Identifier:
NCT01549080
First received: February 27, 2012
Last updated: March 7, 2012
Last verified: June 2011
History of Changes
  Purpose

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 Intervention
Thalassemia
 Drug: Yisuishengxue Granule

Study Type: Observational
Study Design: 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.

Resource links provided by NLM:

MedlinePlus related topics: Thalassemia
U.S. FDA Resources

Further study details as provided by Guang'anmen Hospital of China Academy of Chinese Medical Sciences:

Primary Outcome Measures:
  • Clinical effects on heamoglobin changes [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Changes from Baseline in heamoglobins at 3and 6 months


Secondary Outcome Measures:
  • Chinese Medicine syndrome improvment [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    changes from baseline in syndromes at 3 and 6 months


Biospecimen Retention:   Samples With DNA

Peripheral blood and bone marrow cells


Enrollment: 2
Study Start Date: July 2011
Study Completion Date: January 2012
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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)：

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   3 Years to 40 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01549080

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

Additional Information:
the internet-link to Guang'anmen Hospital China Academy of Chinese Medical Sciences  This link exits the ClinicalTrials.gov site

No publications provided

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
Study First Received: February 27, 2012
Last Updated: March 7, 2012
Health Authority: China: State Administration of Traditional Chinese Medicine of the People's Republic of China

Keywords provided by 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

ClinicalTrials.gov processed this record on May 21, 2013