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Efficacy of Chinese Herbal granules for “Bu Shen Jian Pi Qu Yu” (Strengthening Kidney, Supplementing Spleen and Resolving Blood Stasis) on early phase hemopoletic recovery in severe aplastic anemia: a multi-center, randomised double-blind, controlled clinical trial

Efficacy of Chinese Herbal granules for

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-INR-16007707
Enrollment
Unknown
Registered
2016-01-05
Start date
2016-01-01
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

severe aplastic anemia(SAA)

Interventions

controlled arm:IST+ Chinese herbal simulants
treatment group:IST+ Chinese herbal granules

Sponsors

Zhejiang Provincial Hospital of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
14 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. meet the diagnosis of severe aplastic anemia, and the disease should be in the early phase of hemopoietic recovery; 2. patients from 14 years old to 80 years old; 3. not enrolled in other clinical trials; 4. No history of immunosuppressive therapy in past one month (for example, ATG/ALG +/- CsA or CsA).

Exclusion criteria

Exclusion criteria: 1. pancytopenia attributing to other disorders, such as paroxysmal nocturnal hemoglobinuria, myelodysplastic syndrome, acute arrest of hemopoiesis, myelofibrosis and etc.; 2. patients candidate for hemopoietic stem cell transplantation; 3. severe comorbidities associated with heart, brain, liver and kidney or psychosis, or ECOG score >2 points; 4. women in pregnancy or breast feeding period; 5. patients unable to take, or allergy to Chinese herbal granules.

Design outcomes

Primary

MeasureTime frame
general index;western medicine efficacy;Traditional Chinese Medicine efficacy;quality of life;

Secondary

MeasureTime frame
immunoregulative index;telomerase activity of hemopoietic stem cells in bone marrow;gene expression of telomerase reverse transcriptase;TCR V-beta gene of bone marrow;serum VEGF level;

Countries

China

Contacts

Public ContactYe Baodong, Zhou Yuhong
13588453501@163.com+86 13588453501,+86 13588887286

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026