Study of Effects of YisuiShengxueGranules on Thalassemia

NCT01549080 | Completed DMC

• 2 other identifiers: 2011001P02/June 3rd, 20112010CB530406
• Study Type: observational
• Target: 2
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Thalassemia

Keywords

traditional chinese medicine and thalassemia

Outcome Measures

Primary Outcomes (1)

• Clinical effects on heamoglobin changes

  Changes from Baseline in heamoglobins at 3and 6 months

  6 months

Secondary Outcomes (1)

• Chinese Medicine syndrome improvment

  6 months

Study Arms (2)

research

biological research on the effects of yisuishengxuegranule

Drug: Yisuishengxue Granule

clinical research

clinical research on thalassemia

Drug: Yisuishengxue Granule

Interventions

Yisuishengxue Granule DRUG

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.

Also known as: Yisui Shengxue Granules replacer (placebo)：

clinical research; research

Eligibility Criteria

• Age: 3 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guang'anmen Hospital of China Academy of Chinese Medical Sciences: lead

Related Publications (2)

• Foong WC, Loh CK, Ho JJ, Lau DS. Foetal haemoglobin inducers for reducing blood transfusion in non-transfusion-dependent beta-thalassaemias. Cochrane Database Syst Rev. 2023 Jan 13;1(1):CD013767. doi: 10.1002/14651858.CD013767.pub2.

  PMID: 36637054 DERIVED

• Cheng YL, Zhang XH, Sun YW, Wang WJ, Huang J, Chu NL, Fang SP, Wu ZK. Genomewide DNA Methylation Responses in Patients with beta-Thalassemia Treated with Yisui Shengxue Granules (). Chin J Integr Med. 2019 Jul;25(7):490-496. doi: 10.1007/s11655-018-2777-9. Epub 2018 May 3.

  PMID: 29761313 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral blood and bone marrow cells

MeSH Terms

Conditions

Thalassemia

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Wu zhikui, MD

  Guang'anmen Hospital of China Academy of Chinese Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Study Record Dates

• First Submitted: February 27, 2012
• First Posted: March 8, 2012
• Study Start: July 1, 2011
• Primary Completion: October 1, 2011
• Study Completion: January 1, 2012
• Last Updated: March 8, 2012

Record last verified: 2011-06