Iron-Deficiency AnemiaPhase 2BXYMIDANCT03232554
Buxue Yimu Pills for Gynecological Iron-Deficiency Anemia
A Phase 2 study testing Buxue Yimu Pills, Buxue Yimu Pills &Ferrous Sulfate and Ferrous Sulfate in people with Iron-Deficiency Anemia, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
This study evaluates Buxue Yimu Pills，Ferrous Sulfate and the addition of Buxue Yimu Pills to Ferrous Sulfate in the treatment of Iron-Deficiency Anemia in adults women. One third of participanta will receive Buxue Yimu Pills, one third of participanta will receive Buxue Yimu Pills, one third of participanta will… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Iron-Deficiency Anemia
- What is being tested?
- Buxue Yimu Pills, Buxue Yimu Pills &Ferrous Sulfate and Ferrous Sulfate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2017to 28 Feb 2019
- Phase
- Phase 2
- 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 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Subject is a female between the age of 18 and 50.
- Subject suffers from mild to moderate anemia with a hemoglobin between 80g/L and 110 g/L.
- Subject has definite gynecological etiological factors of iron deficiency
- Subject provides written informed consent.
Who cannot join
- Subject underwent chronic digestive tract inflammation，uncontrolled digestive or urinary system bleeding.
- Subject has other complications in addition to gynecological diseases leading to iron deficiency，such as hemorrhagic diseases of hematologic system，parasitic diseases like ancylostomiasis，chronic intravascular hemolysis，mechanical hemolysis like prosthetic valve，renal dysfunction and hemodialysis.
- Subject is pregnant or lactating.
- Subject has a severe systemic disease, such as cardiovascular system
- Subject has a history of malignancy or radiotherapy.
- Subject has undergone any Iron deficiency anemia treatment including Iron supplements or blood transfusion within 1month prior to randomization.
- Subject has mental disorder incapable of elementary cooperations.
- Subject has participated in other clinical researches of medicine within 1month prior to randomization.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Lei Li
Beijing, Beijing Municipality, 10000
Lei L Li, MD, 13911988831 ext. ＋86, lileigh@163.com
About this study
Official title: Clinical Observation of The Gynecological Iron-Deficiency Anemia Treated With Buxue Yimu Pills
This study evaluates Buxue Yimu Pills，Ferrous Sulfate and the addition of Buxue Yimu Pills to Ferrous Sulfate in the treatment of Iron-Deficiency Anemia in adults women. One third of participanta will receive Buxue Yimu Pills, one third of participanta will receive Buxue Yimu Pills, one third of participanta will receive Ferrous Sulfate，and the another third will receive Buxue Yimu Pills and Ferrous Sulfate in combination.
Read the detailed description
Buxue Yimu Pills, Ferrous Sulfate each Improve anemia, but they do so by different machanisms. We generally treat patients with uncomplicated Iron Deficiency Anemia with oral iron due to the ease of administration，and Ferrous Sulfate is one of the most commonly used drugs.
Buxue Yimu Pills consists of multiple chinses herbs including Angelica Sinensis，Astragalus，Donkey-Hide Gelatin，Herba Leonuri，Citrus etc., which gains widespread application in the treatment after women's abortion or operations of uterine cavity. Based on the characteristics above, we try to explore its clinical application value in Gynecological Iron-Deficiency Anemia.
- Conditions
- Iron-Deficiency Anemia
- Being tested
- Buxue Yimu Pills, Buxue Yimu Pills &Ferrous Sulfate, Ferrous Sulfate
- Keywords
- Iron-Deficiency Anemia, Buxue Yimu Pills, Ferrous Sulfate, clinical observations, adult women, Metabonomics
- Medical subject headings
- Anemia, Iron-Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Buxue Yimu PillsDrug
Also called Buxue Yimu pellets
Buxue Yimu Pills 12g pill by mouth, twice daily.
Buxue Yimu Pills &Ferrous SulfateDrug
Also called Buxue Yimu pellets,Iron Sulfate
Buxue Yimu Pills 12g pill by mouth, twice daily and Ferrous Sulfate 0.3g tablet by mouth, three times daily
Ferrous SulfateDrug
Also called Iron Sulfate
Ferrous Sulfate 0.3g tablet by mouth, three times daily
| Study group | Role | What they receive |
|---|---|---|
| Buxue Yimu Pills | Experimental | Buxue Yimu Pill 12g pill by mouth, twice daily Receives: Drug: Buxue Yimu Pills |
| Buxue Yimu Pills &Ferrous Sulfate | Experimental | Buxue Yimu Pill 12g pill by mouth, twice daily and Ferrous Sulfate 0.3g tablet by mouth, three times daily Receives: Drug: Buxue Yimu Pills &Ferrous Sulfate |
| Ferrous Sulfate | Active comparator | Ferrous Sulfate 0.3g tablet by mouth, three times daily Receives: Drug: Ferrous Sulfate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Blood Count
Anemia Related Assessment
Measured: 5 minutes
Secondary outcomes (7)
The Short Form-36 Health Survey (Sf-36)
Information about health
Measured: 10 minutes
Hepatic Function
Safety Monitoring
Measured: 5 minutes
Renal Function
Safety Monitoring
Measured: 5 minutes
Blood Glucose
Safety Monitoring
Measured: 5 minutes
Electrolyte Semiconductor Junction
Safety Monitoring
Measured: 5 minutes
Electrocardiogram(ECG)
Safety Monitoring
Measured: 5 minutes
Iron Metabolism index
Anemia Related Assessment
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2017
- Study start1 Jun 2017
- Primary completion31 Dec 2018 (estimated)
- Study completion28 Feb 2019 (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 Iron-Deficiency AnemiaStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- 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
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- One third of participanta will receive Buxue Yimu Pills, one third of participanta will receive Buxue Yimu Pills, one third of participanta will receive Ferrous Sulfate，and the another third will receive Buxue Yimu Pills and Ferrous Sulfate in combination.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aijun Sun, Peking Union Medical College Hospital
- Investigators
- Aijun AJ Sun, MD, Principal investigator, Peking Union Medical College Hospital, Chinese Academy of Medicine Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03232554
- Sponsor's protocol ID
- IDA201706
- Acronym
- BXYMIDA
- Status last verified
- Feb 2018
- First submitted
- 8 Jul 2017
- Last updated
- 13 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Network platform, and the website will be attached later.
Publications
Percy L, Mansour D, Fraser I. Iron deficiency and iron deficiency anaemia in women. Best Pract Res Clin Obstet Gynaecol. 2017 Apr;40:55-67. doi: 10.1016/j.bpobgyn.2016.09.007. Epub 2016 Oct 1.
PubMed 28029503Seid MH, Butcher AD, Chatwani A. Ferric Carboxymaltose as Treatment in Women with Iron-Deficiency Anemia. Anemia. 2017;2017:9642027. doi: 10.1155/2017/9642027. Epub 2017 Apr 13.
PubMed 28487769Wang YF, Deng Y, Zhang SY, Liu D, Luo B, Wang X, Deng M, Ma RL, Sun AJ. Efficacy and Mechanism of Buxue Yimu Pills on Gynecological Anemia: A Combination of Clinical and Network Pharmacology Study. Chin J Integr Med. 2022 Dec;28(12):1072-1080. doi: 10.1007/s11655-021-3296-7. Epub 2021 Jul 9.
PubMed 34241801
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Observation of The Gynecological Iron-Deficiency Anemia Treated With Buxue Yimu Pills
- ClinicalTrials.gov ID
- NCT03232554
- Acronym / sponsor ID
- BXYMIDA / IDA201706
- Conditions
- Iron-Deficiency Anemia
- Keywords
- Iron-Deficiency Anemia, Buxue Yimu Pills, Ferrous Sulfate, clinical observations, adult women, Metabonomics
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 31 Dec 2018 (estimated)
- Study completion
- 28 Feb 2019 (estimated)
- First posted
- 28 Jul 2017 (actual)
- 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.
This study evaluates Buxue Yimu Pills，Ferrous Sulfate and the addition of Buxue Yimu Pills to Ferrous Sulfate in the treatment of Iron-Deficiency Anemia in adults women. One third of participanta will receive Buxue Yimu Pills, one third of participanta will receive Buxue Yimu Pills, one third of participanta will receive Ferrous Sulfate，and the another third will receive Buxue Yimu Pills and Ferrous Sulfate in combination.
Detailed description
Buxue Yimu Pills, Ferrous Sulfate each Improve anemia, but they do so by different machanisms. We generally treat patients with uncomplicated Iron Deficiency Anemia with oral iron due to the ease of administration，and Ferrous Sulfate is one of the most commonly used drugs.
Buxue Yimu Pills consists of multiple chinses herbs including Angelica Sinensis，Astragalus，Donkey-Hide Gelatin，Herba Leonuri，Citrus etc., which gains widespread application in the treatment after women's abortion or operations of uterine cavity. Based on the characteristics above, we try to explore its clinical application value in Gynecological Iron-Deficiency Anemia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- One third of participanta will receive Buxue Yimu Pills, one third of participanta will receive Buxue Yimu Pills, one third of participanta will receive Ferrous Sulfate，and the another third will receive Buxue Yimu Pills and Ferrous Sulfate in combination.
| Arm | Type | Receives |
|---|---|---|
| Buxue Yimu Pills | Experimental | Drug: Buxue Yimu PillsBuxue Yimu Pill 12g pill by mouth, twice daily |
| Buxue Yimu Pills &Ferrous Sulfate | Experimental | Drug: Buxue Yimu Pills &Ferrous SulfateBuxue Yimu Pill 12g pill by mouth, twice daily and Ferrous Sulfate 0.3g tablet by mouth, three times daily |
| Ferrous Sulfate | Active comparator | Drug: Ferrous SulfateFerrous Sulfate 0.3g tablet by mouth, three times daily |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Subject is a female between the age of 18 and 50.
- Subject suffers from mild to moderate anemia with a hemoglobin between 80g/L and 110 g/L.
- Subject has definite gynecological etiological factors of iron deficiency
- Subject provides written informed consent.
Key exclusion criteria (8 listed)
- Subject underwent chronic digestive tract inflammation，uncontrolled digestive or urinary system bleeding.
- Subject has other complications in addition to gynecological diseases leading to iron deficiency，such as hemorrhagic diseases of hematologic system，parasitic diseases like ancylostomiasis，chronic intravascular hemolysis，mechanical hemolysis like prosthetic valve，renal dysfunction and hemodialysis.
- Subject is pregnant or lactating.
- Subject has a severe systemic disease, such as cardiovascular system
- Subject has a history of malignancy or radiotherapy.
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 |
|---|---|---|
| Buxue Yimu PillsAlso: Buxue Yimu pelletsBuxue Yimu Pills 12g pill by mouth, twice daily. | Drug | Buxue Yimu Pills |
| Buxue Yimu Pills &Ferrous SulfateAlso: Buxue Yimu pellets,Iron SulfateBuxue Yimu Pills 12g pill by mouth, twice daily and Ferrous Sulfate 0.3g tablet by mouth, three times daily | Drug | Buxue Yimu Pills &Ferrous Sulfate |
| Ferrous SulfateAlso: Iron SulfateFerrous Sulfate 0.3g tablet by mouth, three times daily | Drug | Ferrous Sulfate |
Primary outcome
Complete Blood Count
Time frame: 5 minutes
Anemia Related Assessment
7 secondary outcomes
The Short Form-36 Health Survey (Sf-36)
Time frame: 10 minutes
Hepatic Function
Time frame: 5 minutes
Renal Function
Time frame: 5 minutes
Blood Glucose
Time frame: 5 minutes
Electrolyte Semiconductor Junction
Time frame: 5 minutes
Electrocardiogram(ECG)
Time frame: 5 minutes
Iron Metabolism index
Time frame: 5 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2018.
- Results publication: PubMed 28029503Percy L, Mansour D, Fraser I. Iron deficiency and iron deficiency anaemia in women. Best Pract Res Clin Obstet Gynaecol. 2017 Apr;40:55-67. doi: 10.1016/j.bpobgyn.2016.09.007. Epub 2016 Oct 1.
- Results publication: PubMed 28487769Seid MH, Butcher AD, Chatwani A. Ferric Carboxymaltose as Treatment in Women with Iron-Deficiency Anemia. Anemia. 2017;2017:9642027. doi: 10.1155/2017/9642027. Epub 2017 Apr 13.
- Derived from this study: PubMed 34241801Wang YF, Deng Y, Zhang SY, Liu D, Luo B, Wang X, Deng M, Ma RL, Sun AJ. Efficacy and Mechanism of Buxue Yimu Pills on Gynecological Anemia: A Combination of Clinical and Network Pharmacology Study. Chin J Integr Med. 2022 Dec;28(12):1072-1080. doi: 10.1007/s11655-021-3296-7. Epub 2021 Jul 9.
- Ferric Carboxymaltose as Treatment in Women with Iron-Deficiency Anemia.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Network platform, and the website will be attached later.
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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.
Aijun AJ Sun, MD principal investigator
Peking Union Medical College Hospital, Chinese Academy of Medicine Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Buxue Yimu Pills, Buxue Yimu Pills &Ferrous Sulfate and Ferrous Sulfate in people with Iron-Deficiency Anemia, run by Peking Union Medical College Hospital 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 4 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 Feb 2018. 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?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Lei L Li, MD (139-1198-8831 ext. ＋86, lileigh@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete Blood Count (time frame: 5 minutes). 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 NCT03232554, 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 Feb 2018.