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Study to evaluate efficacy and safety of SQSB decoction in management of Immune Thrombocytopenia

Study to evaluate efficacy and safety of SQSB decoction in management of Immune Thrombocytopenia

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IPR-16010154
Enrollment
Unknown
Registered
2016-12-15
Start date
2016-12-15
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

Immune Thrombocytopenia

Interventions

Treatment Group:Chinese herbal granule pieces of SQSB decoction
Control Group:Placebo of simulated herbal granule pieces

Sponsors

Shanghai Municiple Hospital of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) Meeting the diagnostic criteria of Immune Thrombocytopenia(ITP), and TCM pattern is Deficiency of both Qi and Yin based on syndrome differentiation; (2) Aged 18 to 65 years; (3) Platelet count detected twice in succession to be below normal(100×10^9/L), and =30×10^9/L; (4) untreated with corticosteroid or unresponded to 4-week standard dose of corticosteroid treatment; (5) Maintenance dose of corticosteroid <15mg / day (converting according to the equivalent dose of prednisone); (6) Willing to sign on the informed consent.

Exclusion criteria

Exclusion criteria: (1) Secondary thrombocytopenic purpura; (2) Meeting western diagnostic criteria, but the TCM syndrome is not Deficiency of both Qi and Yin pattern; (3) Allergic constitution or allergic to multiple drugs; (4) Pregnant or lactating women; (5) Severe mental disease; (6) Have or suspected to have a history of abuse of alcohol or drug ; (7) Abnormal liver or kidney function (serum level of alanine aminotransferase > 2 times upper normal limit, creatinine > 125umol/L); (8) Active bleeding (daily blood loss = 50ml)within latest one week; (9) Taking other Chinese medicine within latest four weeks.

Design outcomes

Primary

MeasureTime frame
Platelet count;TCM symptom score;

Secondary

MeasureTime frame
Quality of life assessment;

Countries

China

Contacts

Public ContactQi Hu

Shanghai Municiple Hospital of Traditional Chinese Medicine

queenhu_cn@aliyun.com+86 13641951569

Outcome results

None listed

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