A Phase 4 interventional study of Colla corii asini and a Simulate Agent of Colla corii asini granule in Thalassemia, sponsored by The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine. Status unknown at 12 sites in China. Open to female participants aged 20 Years to 50 Years. Per ClinicalTrials.gov, last updated 2018-12-27.
Sponsored by The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine · Phase 4, Interventional, and Treatment
480 pregnant patients diagnosed of silent or standard α-thalassemia, HbH disease, minor or intermediate β-thalassemia with mild anemia will be randomly assigned to treatment group and control group. Patients in the treatment group will be given 15 g of Colla corii asini powder form daily for 8 weeks and followed up to 42 days postpartum while the control group will be observed and followed up in the same period treated with placebo. Levels of hemoglobin(Hb), reticulocyte (RET), immaturity reticulocyte (IRF), indirect bilirubin(IBIL), total bilirubin(TBIL), lactic dehydrogenase(LDH) will be measured on three visits(baseline, week 4 and week 8). The curative effect of TCM Syndrome( week 8) and undesirable pregnancy outcomes(42 days after giving birth) will be observed.
Thalassemia is a type of hemolytic anemia disease caused by genetic defect of synthesis in one or more globin chains. Among all the single genetic disorders thalassemia has the highest incidence rate in the world and causes heavy burdens on public health system. In China, the southern provinces suffer from high incidence of thalassemia, which is particularly common in the population of Guangdong, Guangxi and Yunnan provinces. Epidemiological studies showed that in Guangdong alone about 17.83 % of the 14,332 pregnant women across 21 regions examined were diagnosed as carriers of thalassemia .
Recent studies showed that compared with healthy controls, women with thalassemia are associated with a wide range of abnormality and adverse pregnancy outcomes including cardiovascular disease, thrombotic disease, spontaneous miscarriage, premature delivery, oligohydramnios, fetal growth restriction and low birth weight. Currently there is no consensus on treating anemia in pregnant thalassemia patients. Due to the absence of an safe and effective therapeutic measures， many thalassemia patients are prone to develop low level of Hb, which can severely impact the fetal growth and maternal health.
In traditional Chinese medicine (TCM), Colla corii asini (CCA, E'jiao) is a gelatin-like traditional Chinese medicine refined from donkey hide and has been widely used in clinical antanemic therapy for more than 2000 years. In the last decade, many studies had addressed the effect of CCA on the anemia using modern pharmacological approaches. The results indicated that CCA contains collagen protein,glycogen and a variety of trace elements, a variety of amino acids, etc. the main components of CCA can promote hematopoiesis by a number of mechanisms which eventually increase the peripheral erythrocyte counts and Hb concentration. Therefore, the investigators proposed that the hematopoietic effects of CCA might also contribute to the treatment of thalassemia with insuffcient or abnormal Hb concentration.
The study aims to evaluate the efficacy and safety of Colla corii asini (CCA ) in improve anemia during pregnancy among silent or standard α-thalassemia, HbH disease, minor or intermediate β-thalassemia. Four hundred and eighty pregnant patients who meet inclusion criteria will be randomly assigned to either the treatment group or control group. Patients in the treatment group will be given 15 g of CCA daily for 8 weeks and followed up to 42 days postpartum, while the control group were observed and followed up in the same period treated with placebo. Levels of hemoglobin (Hb),reticulocyte (RET), immaturity reticulocyte (IRF), indirect bilirubin (IBIL), total bilirubin (TBIL), lactic dehydrogenase (LDH) will be measured on three visits (baseline, week 4 and week 8). The curative effect of TCM Syndrome( week 8) and undesirable pregnancy outcomes(42 days after giving birth) will be observed.
250 studies on the registry are indexed under Thalassemia; 43 are open to participants now.
This study's planned enrollment of 480 is above the median of 33 across 170 interventional studies indexed under Thalassemia.
Browse Thalassemia studies →The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine is the lead sponsor of 11 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
15g of Colla corii asini granule( produced by Dong-E E-Jiao Co., Ltd) ， taken once daily for 8 weeks
Drug: Colla corii asini
a Simulate Agent of Colla corii asini granule， similar in size, shape，color and taste to Colla corii asini granule, taken once daily for 8 weeks
Drug: a Simulate Agent of Colla corii asini granule
15 g Colla corii asini granule daily for 8 weeks
Also known as: donkey-hide gelatin
15 g a Simulate Agent of Colla corii asini granule daily for 8 weeks
Also known as: Placebo of Colla corii asini granule
Hemoglobin(Hb)
the change of hemoglobin(g/L)
Time frame: baseline, week 4 and week 8
reticulocyte (RET)
the change of reticulocyte (RET)count（×10\^9/L）
Time frame: baseline, week 4 and week 8
immature reticulocyte fraction（IRF）
the change of immature reticulocyte fraction(%)
Time frame: baseline, week 4 and week 8
adverse event
undesirable pregnancy outcomes
Time frame: tracked for 42 days after giving birth
indirect bilirubin(IBIL)
the change of indirect bilirubin(IBIL)(μmol/L)
Time frame: baseline, week 4 and week 8
total bilirubin(TBIL)
the change of total bilirubin(TBIL) (μmol/L)
Time frame: baseline, week 4 and week 8
lactic dehydrogenase(LDH)
the change of lactic dehydrogenase(LDH)(U/L)
Time frame: baseline, week 4 and week 8
anaemia cure rates
anaemia cure rates(%):The concentration of hemoglobin was higher than baseline \> 5g/L;The improvement rate = improved cases/the total number of cases \* 100%
Time frame: week 8
The curative effect of TCM Syndrome
the change of the TCM syndrome scores of two groups before and after treatment（%）
Time frame: week 8
Plan to share: Yes — all collected IPD, all IPD that underlie results in a publication
Supporting information: Study protocol, Informed consent form, Clinical study report
Time frame: starting in May 2020 when the study have been completed and publication of a clinical trial report.
Access criteria: the information collected about the study will be used to support other research in the future, and may be shared anonymously with other researchers,data will be freely available to anyone upon request.
Started Mar 2018 (actual). Primary completion is estimated for Oct 2019, 19 months after the start.
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This study is status unknown, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Colla corii asini
The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine