ThalassemiaEarly Phase 1NCT02772016
Therapeutic Effect of Colla Corii Asini on Improving Anemia and Hemoglobin Composition in Pregnant Women With Thalassemia
A Early Phase 1 study testing Colla corii asini in people with Thalassemia, run by Yanfang Li at 1 site in China.
Trial summary
Seventy-two pregnant patients diagnosed of minor or intermediate beta thalassemia with mild anemia were randomly assigned to treatment group and control group. Patients in the treatment group were given 15 g of Colla corii asini in powder form daily for 4 weeks while the control group were observed and followed up in… Read more about this study
- Who is it for?
- Ages 20 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Thalassemia
- What is being tested?
- Colla corii asini
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- Mar 2015to May 2016
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- pregnant women diagnosed as thalassemia carriers by genetic test with clinical presentation of minor or intermediate β- thalassemia;
- patients with mild anemia (80 g/L≤ Hb<110 g/L) prior to study enrollment;
- singleton pregnancy;
- patients having not received blood transfusion or any forms of anti-anemia treatment in Western Medicine or Traditional Chinese Medicine in the last 12 weeks;
- informed consent obtained.
Who cannot join
- patients with severe thalassemia;
- patients with severe anemia (Hb<80 g/L) prior to study enrollment;
- twin or multiple pregnancies;
- patients with any of the following abnormalities: immunodeficiency, primary diseases involving cardiovascular system, liver, kidney, gastrointestinal tract, endocrine system and hematological system;
- allergic to two or more drugs;
- patients with mental illness or poor compliance to medical treatment;
- patients having received blood transfusion or any forms of anti-anemia treatment in Western medicine or Traditional Chinese Medicine in the last 12 weeks;
- no informed consent obtained.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
the first affiliated hospital of Guangzhou University of Chinese Medicine
Guangzhou, Guangdong, 510405
Yanfang Li, PhD, +86-20-36598857, gzyanfangli@hotmail.com
About this study
Seventy-two pregnant patients diagnosed of minor or intermediate beta thalassemia with mild anemia were randomly assigned to treatment group and control group. Patients in the treatment group were given 15 g of Colla corii asini in powder form daily for 4 weeks while the control group were observed and followed up in the same period without any treatments. Levels of hemoglobin(Hb), serum iron (SI), serum ferritin (SF) and three types of hemoglobin components [adult hemoglobin (HbA), fetal hemoglobin (HbF), minor adult hemoglobin (HbA2)] were measured before and after treatments.
- Conditions
- Thalassemia
- Being tested
- Colla corii asini
- Medical subject headings
- Thalassemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colla corii asiniDrug
15 g of Colla corii asini in powder form daily for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Patients in the treatment group received daily 15 g oral Colla corii asini(Shandong Dong-E E-Jiao Co., Ltd) in powder form for 4 consecutive weeks. The dosage was adjusted to 10 g per day for 6 consecutive weeks if patients encounter any of the following side effects: swollen gums, dry or sore throat, ulcers in oral cavity. Receives: Drug: Colla corii asini |
| Control group | No intervention | Patients in control groups do not receive any intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin(Hb)
the change of hemoglobin(g/L)
Measured: Four weeks
Adult hemoglobin(HbA)
the change of adult hemoglobin(%)
Measured: Four weeks
Fetal hemoglobin(HbF)
the change of fetal hemoglobin(%)
Measured: Four weeks
Minor adult hemoglobin(HbA2)
the change of minor adult hemoglobin(%)
Measured: Four weeks
Secondary outcomes (9)
Serum iron(SI)
the change of serum iron (umol/L)
Measured: Four weeks
Serum ferritin(SF)
the change of serum ferritin (ng/mL)
Measured: Four weeks
Adverse effect
total white blood count(×109/L)
Measured: Four weeks
Adverse effect
platelet count(×109/L)
Measured: Four weeks
Adverse effect
percentage of neutrophil(%)
Measured: Four weeks
Adverse effect
serum alanine aminotransferase(U/L)
Measured: Four weeks
Adverse effect
serum aspartate aminotransferase(U/L)
Measured: Four weeks
Adverse effect
urea nitrogen (mmol/L)
Measured: Four weeks
Adverse effect
serum creatinine(umol/L)
Measured: Four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2016 (estimated)
- Study startMar 2015
- Primary completionMay 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ThalassemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yanfang Li
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yanfang Li, The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02772016
- Sponsor's protocol ID
- TH-1
- Status last verified
- Apr 2016
- First submitted
- 15 Apr 2016
- Last updated
- 13 May 2016
- Results posted
- No
Publications
Voskaridou E, Balassopoulou A, Boutou E, Komninaka V, Christoulas D, Dimopoulou M, Delaki EE, Loukopoulos D, Terpos E. Pregnancy in beta-thalassemia intermedia: 20-year experience of a Greek thalassemia center. Eur J Haematol. 2014 Dec;93(6):492-9. doi: 10.1111/ejh.12387. Epub 2014 Jun 26.
PubMed 24889414Costa D, Capuano M, Sommese L, Napoli C. Impact of epigenetic mechanisms on therapeutic approaches of hemoglobinopathies. Blood Cells Mol Dis. 2015 Aug;55(2):95-100. doi: 10.1016/j.bcmd.2015.05.004. Epub 2015 May 12.
PubMed 26142322Pavord S, Myers B, Robinson S, Allard S, Strong J, Oppenheimer C; British Committee for Standards in Haematology. UK guidelines on the management of iron deficiency in pregnancy. Br J Haematol. 2012 Mar;156(5):588-600. doi: 10.1111/j.1365-2141.2011.09012.x.
PubMed 22512001
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Effect of Colla Corii Asini on Improving Anemia and Hemoglobin Composition in Pregnant Women With Thalassemia
- ClinicalTrials.gov ID
- NCT02772016
- Acronym / sponsor ID
- TH-1
- Conditions
- Thalassemia
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Yanfang LiUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- May 2016 (estimated)
- First posted
- 13 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Seventy-two pregnant patients diagnosed of minor or intermediate beta thalassemia with mild anemia were randomly assigned to treatment group and control group. Patients in the treatment group were given 15 g of Colla corii asini in powder form daily for 4 weeks while the control group were observed and followed up in the same period without any treatments. Levels of hemoglobin(Hb), serum iron (SI), serum ferritin (SF) and three types of hemoglobin components [adult hemoglobin (HbA), fetal hemoglobin (HbF), minor adult hemoglobin (HbA2)] were measured before and after treatments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Drug: Colla corii asiniPatients in the treatment group received daily 15 g oral Colla corii asini(Shandong Dong-E E-Jiao Co., Ltd) in powder form for 4 consecutive weeks. The dosage was adjusted to 10 g per day for 6 consecutive weeks if patients encounter any of the following side effects: swollen gums, dry or sore throat, ulcers in oral cavity. |
| Control group | No intervention | –Patients in control groups do not receive any intervention. |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- pregnant women diagnosed as thalassemia carriers by genetic test with clinical presentation of minor or intermediate β- thalassemia;
- patients with mild anemia (80 g/L≤ Hb<110 g/L) prior to study enrollment;
- singleton pregnancy;
- patients having not received blood transfusion or any forms of anti-anemia treatment in Western Medicine or Traditional Chinese Medicine in the last 12 weeks;
- informed consent obtained.
Key exclusion criteria (8 listed)
- patients with severe thalassemia;
- patients with severe anemia (Hb<80 g/L) prior to study enrollment;
- twin or multiple pregnancies;
- patients with any of the following abnormalities: immunodeficiency, primary diseases involving cardiovascular system, liver, kidney, gastrointestinal tract, endocrine system and hematological system;
- allergic to two or more drugs;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Colla corii asini15 g of Colla corii asini in powder form daily for 4 weeks | Drug | Intervention group |
Primary outcome
Hemoglobin(Hb)
Time frame: Four weeks
the change of hemoglobin(g/L)
Adult hemoglobin(HbA)
Time frame: Four weeks
the change of adult hemoglobin(%)
Fetal hemoglobin(HbF)
Time frame: Four weeks
the change of fetal hemoglobin(%)
Minor adult hemoglobin(HbA2)
Time frame: Four weeks
the change of minor adult hemoglobin(%)
9 secondary outcomes
Serum iron(SI)
Time frame: Four weeks
Serum ferritin(SF)
Time frame: Four weeks
Adverse effect
Time frame: Four weeks
Adverse effect
Time frame: Four weeks
Adverse effect
Time frame: Four weeks
Adverse effect
Time frame: Four weeks
Adverse effect
Time frame: Four weeks
Adverse effect
Time frame: Four weeks
Adverse effect
Time frame: Four weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2016.
- Background: PubMed 24889414Voskaridou E, Balassopoulou A, Boutou E, Komninaka V, Christoulas D, Dimopoulou M, Delaki EE, Loukopoulos D, Terpos E. Pregnancy in beta-thalassemia intermedia: 20-year experience of a Greek thalassemia center. Eur J Haematol. 2014 Dec;93(6):492-9. doi: 10.1111/ejh.12387. Epub 2014 Jun 26.
- Background: PubMed 26142322Costa D, Capuano M, Sommese L, Napoli C. Impact of epigenetic mechanisms on therapeutic approaches of hemoglobinopathies. Blood Cells Mol Dis. 2015 Aug;55(2):95-100. doi: 10.1016/j.bcmd.2015.05.004. Epub 2015 May 12.
- Background: PubMed 22512001Pavord S, Myers B, Robinson S, Allard S, Strong J, Oppenheimer C; British Committee for Standards in Haematology. UK guidelines on the management of iron deficiency in pregnancy. Br J Haematol. 2012 Mar;156(5):588-600. doi: 10.1111/j.1365-2141.2011.09012.x.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Colla corii asini in people with Thalassemia, run by Yanfang Li at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yanfang Li, PhD (+86-20-36598857, gzyanfangli@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemoglobin(Hb) (time frame: Four weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02772016, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2016; AzTrials last refreshed its copy on 7 Nov 2026.