'Yu Xue Qi Huo' theory based integrated Traditional Chinese and Western Medicine in the diagnosis and treatment of stratified relapsed and refractory primary immune thrombocytopenia

• Register: ChiCTR
• Last refreshed on: 18 April 2017
• Main ID: ChiCTR-INR-16009363
• Date of registration: 2016-10-10
• Prospective Registration: Yes
• Primary sponsor: Ruijin Hospital affiliated to Shanghai Jiaotong University School of Medicine
• Public title: 'Yu Xue Qi Huo' theory based integrated Traditional Chinese and Western Medicine in the diagnosis and treatment of stratified relapsed and refractory primary immune thrombocytopenia
• Scientific title: 'Yu Xue Qi Huo' theory based integrated Traditional Chinese and Western Medicine in the diagnosis and treatment of stratified relapsed and refractory primary immune thrombocytopenia
• Date of first enrolment: 2016-10-13
• Target sample size: Study Group A:55;Study Group A:55;Control group B:55;Control group B:55;Study Group C:45;Study Group C:45;Control Group D:45;Control Group D:45;
• Recruitment status: Recruiting
• URL: http://www.chictr.org.cn/showproj.aspx?proj=15787
• Study type: Interventional study
• Study design: Randomized parallel controlled trial
• Phase: New Treatment Measure Clinical Study

Countries of recruitment

China

Contacts

• Name: Junmin Li
• Affiliation: Ruijin hospital affiliated to Shanghai Jiaotong University School of Medicine, Shanghai Institute of Hematology

• Name: Junmin Li
• Affiliation: Ruijin hospital affiliated to Shanghai Jiaotong University School of Medicine, Shanghai Institute of Hematology

Key inclusion & exclusion criteria

Inclusion criteria: 1. male or female aged between 18 and 75 years;
2. Yinxu typed Relapsed or refractory ITP patients diagnosed with Chinese Consensus on the Diagnosis and Treatment for Adult Immunothrombocytopenia (2011 Edition) who haven't achieved remission after four or more weeks treatment of glucocorticoids;
3. Platelet count below 30*10^9/L twice in succession (not inspected in the same day);
4. Written informed consent.
Exclusion criteria: 1. ITP patients diagnosed by modern medicine, but not Yinxu type by traditional Chinese medicine;
2. Patients with thrombus history;
3. HCV, HBV, or HIV carriers or patients;
4. Patients allergic to multiple medicine;
5. Pregnant or nursing women;
6. Psychiatric history;
7. History of suspected abuse of alcohol or drugs;
8. Severe heart, lung, liver or kidney dysfunction;
9. Severe or uncontrolled infection;
10. Patients who have taken traditional Chinese medicine during the last four weeks or who have participated in other clinical trials;
11. Other situations not approved by researchers.

Age minimum: 18
Age maximum: 75
Gender: Both

Health Condition(s) or Problem(s) studied

Immune Thrombocytopenia

Intervention(s)

Study Group A:Yangyin Traditional Chinese Medicine: brew the TCM granules in warm water, 1 pack bid p.o. 1 hour after meal for 6 months continuously;Study Group A:Cyclosporin A capsules: 5mg/kg/d p.o., adjusted according to the serum CsA concentration;Control group B:Traditional Chinese Medicine for control group;Control group B:Cyclosporin A capsules: 5mg/kg/d p.o., adjusted according to the serum CsA concentration ;Study Group C:Yangyin Traditional Chinese Medicine: brew the TCM granules in warm water, 1 pack bid p.o. 1 hour after meal for 6 months continuously ;Study Group C:rhTPO: 1ug/kg/d qd for 14 days continuously, ih, until platelet count reaches 100×10^9/L;Control Group D:Traditional Chinese Medicine for control group;Control Group D:rhTPO: 1ug/kg/d qd for 14 days continuously, ih, until platelet count reaches 100×10^9/L ;

Primary Outcome(s)

platelet count;Bone marrow proliferation;Bone marrow biopsy;

Secondary Outcome(s)

Serum TPO concentration;Serum TPO antibody;

Source(s) of Monetary Support

Shanghai Municipal Commission of Health and Family Planning, Office of Development of Shanghai Traditional Chinese Medicine