AnemiaPhase 3NCT04974073
Development of PHY606 as Adjunct Therapy for Anemia Patients
A Phase 3 study testing PHY606 in people with Anemia and Herbal Interaction, run by Sheng-Teng Huang at 1 site in Taiwan.
Trial summary
Many reasons can cause anemia, decreased RBC production or increased destruction of circulation RBC. The investigators investigate the Danggui Buxue Tang (PHY606) composed of Angelicae Sinensis Radix and Astragali Radix in the fields of genomic and metabolomics in the healthy people and the patiens with anemia. Read more about this study
- Who is it for?
- Ages 20 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Anemia, Herbal Interaction
- What is being tested?
- PHY606
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteTaiwan
- Study dates
- 22 Aug 2017to 18 Nov 2019
- Phase
- Phase 3
- 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 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- female: Hb<11 g/dL; male: Hb<13.5 g/dL
- has no allergic reaction to TCM
Who cannot join
- below 20 years old
- ever drug abuse or still in drug abuse
- pregnant or in breast-feeding women
- with psychotic disorders
- cardiac arrhythmia with pacemaker
- dyscoagulation or thrombocytopenia (platelet< 15000/uL) or liver dysfunction (> 2 fold normal range)
- with severe disease (cardiac arrest, heart failure, COPD, GI bleeding, etc.)
- under another clinical trials
Trial locations and contacts
1 site in 1 country.
About this study
Many reasons can cause anemia, decreased RBC production or increased destruction of circulation RBC. The investigators investigate the Danggui Buxue Tang (PHY606) composed of Angelicae Sinensis Radix and Astragali Radix in the fields of genomic and metabolomics in the healthy people and the patiens with anemia.
Read the detailed description
Many reasons can cause anemia, decreased RBC production or increased destruction of circulating RBC. The reasons of the former are lake of nutrients, bone marrow disorder, low level tropic hormone, inflammation associated with infectious, inflammatory, or malignant disorders and the latter are intravascular hemolysis or blood loss. Anemia is characterized by the sign of pallor (reduced oxyhemoglobin in skin or mucous membranes), fatigue, lightheadedness, and weakness associated with low hemoglobin.
Iron deficiency anemia (IDA) is mainly resulted from inadequate iron uptake of food, malabsorption of iron and blood loss. Adult female are easy to have IDA compared to male because of menstruation, pregnancy, lactation and low caloric uptake leading to iron deficiency. In Taiwan, cancer-related and chronic kidney disease also lead to insufficient secretion of erythropoietin (EPO). The cost of long-term use EPO and its derivative drugs is high. Besides, drug resistance, risk of tumor growth and cardiovascular disease are all important issues. However, ferrotherapy will induce GI upset, muscle pain and skin hives. Also, iron supplementation can lead to an increase in infectious disease morbidity in areas where bacterial infections or where malaria are common.
Based on the concept of dietetic invigoration, the investigators investigate the Danggui Buxue Tang (PHY606) composed of Angelicae Sinensis Radix and Astragali Radix in the fields of genomics and metabolomics in the healthy people and the patients with anemia. In the meantime, the investigators will explore whether PHY606 activates the immune function, improves anemia and reduces the side effects induced by anemia treatment. Furthermore, the novel metabolites from Angelicae Sinensis Radix and Astragali Radix will be tested from clinic back to the bench including immunological potentiation and hematopoietic function. According to the TCM theory, the investigators integrate with modern medicine and molecular biotechnology to investigate anemia and hope to provide the evidence base for clinical application.
- Conditions
- Anemia, Herbal Interaction
- Being tested
- PHY606
- Keywords
- Anemia, Danggui Buxue Tang, PHY606, Side effects, TCM
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PHY606Drug
Also called Danggui Buxue Tang
Danggui Buxue Tang is a well-known TCM formula indicated for anemia through immune modulation and increase energy metabolism
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | with traditional western medicine treatment based on underlined disease |
| PHY606 | Experimental | PHY606 7.5gm BID for 3 months Receives: Drug: PHY606 |
| Healthy group | Other | PHY606 7.5gm BID for 2 days Receives: Drug: PHY606 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Constitution in Chinese Medicine Questionnaire (CCMQ)
Measured: Change from baseline CCMQ at Day0, Day31, Day93 and Day180.
Serum Cytokines
Collect blood and measure the level of serum cytokines.
Measured: Change from baseline serum cytokines at Day0, Day31 and Day93.
Secondary outcomes (4)
Tongue diagnosis
Use tongue photos for analysis
Measured: Change from baseline tongue diagnosis at Day0 and Day93.
Pulse diagnosis
Use the pulse detector to detect the rhythm data of the subject's left and right hand pulse.
Measured: Change from baseline Pulse diagnosis at Day0 and Day93.
Anemia blood test
Collect blood and measure the level of ferritin(ng/mL), TIBC(ug/dL), transferrin(mg/dL).
Measured: Change from baseline anemia blood at Day 0, Day 31 and Day93.
Genotype
Collect blood and analyze the genotype by microarray assay.
Measured: Change from baseline genotype at Day 0, Day 31 and Day93.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2021
- Study start22 Aug 2017
- Primary completion22 Aug 2017
- Study completion18 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnemiaStudies 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
- Phase 3
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheng-Teng Huang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sheng-Teng Huang, China Medical University Hospital
- Investigators
- Sheng-Teng Huang, MD PHD, Principal investigator, China Medical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04974073
- Sponsor's protocol ID
- CMUH106-REC3-028
- Status last verified
- Aug 2021
- First submitted
- 1 Jul 2021
- Last updated
- 16 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of PHY606 as Adjunct Therapy for Anemia Patients
- ClinicalTrials.gov ID
- NCT04974073
- Acronym / sponsor ID
- CMUH106-REC3-028
- Conditions
- Anemia, Herbal Interaction
- Keywords
- Anemia, Danggui Buxue Tang, PHY606, Side effects, TCM
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Sheng-Teng HuangUniversity, hospital or other
- Study start
- 22 Aug 2017 (actual)
- Primary completion
- 22 Aug 2017 (actual)
- Study completion
- 18 Nov 2019 (actual)
- First posted
- 23 Jul 2021 (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.
Many reasons can cause anemia, decreased RBC production or increased destruction of circulation RBC. The investigators investigate the Danggui Buxue Tang (PHY606) composed of Angelicae Sinensis Radix and Astragali Radix in the fields of genomic and metabolomics in the healthy people and the patiens with anemia.
Detailed description
Many reasons can cause anemia, decreased RBC production or increased destruction of circulating RBC. The reasons of the former are lake of nutrients, bone marrow disorder, low level tropic hormone, inflammation associated with infectious, inflammatory, or malignant disorders and the latter are intravascular hemolysis or blood loss. Anemia is characterized by the sign of pallor (reduced oxyhemoglobin in skin or mucous membranes), fatigue, lightheadedness, and weakness associated with low hemoglobin.
Iron deficiency anemia (IDA) is mainly resulted from inadequate iron uptake of food, malabsorption of iron and blood loss. Adult female are easy to have IDA compared to male because of menstruation, pregnancy, lactation and low caloric uptake leading to iron deficiency. In Taiwan, cancer-related and chronic kidney disease also lead to insufficient secretion of erythropoietin (EPO). The cost of long-term use EPO and its derivative drugs is high. Besides, drug resistance, risk of tumor growth and cardiovascular disease are all important issues. However, ferrotherapy will induce GI upset, muscle pain and skin hives. Also, iron supplementation can lead to an increase in infectious disease morbidity in areas where bacterial infections or where malaria are common.
Based on the concept of dietetic invigoration, the investigators investigate the Danggui Buxue Tang (PHY606) composed of Angelicae Sinensis Radix and Astragali Radix in the fields of genomics and metabolomics in the healthy people and the patients with anemia. In the meantime, the investigators will explore whether PHY606 activates the immune function, improves anemia and reduces the side effects induced by anemia treatment. Furthermore, the novel metabolites from Angelicae Sinensis Radix and Astragali Radix will be tested from clinic back to the bench including immunological potentiation and hematopoietic function. According to the TCM theory, the investigators integrate with modern medicine and molecular biotechnology to investigate anemia and hope to provide the evidence base for clinical application.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | –with traditional western medicine treatment based on underlined disease |
| PHY606 | Experimental | Drug: PHY606PHY606 7.5gm BID for 3 months |
| Healthy group | Other | Drug: PHY606PHY606 7.5gm BID for 2 days |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- female: Hb<11 g/dL; male: Hb<13.5 g/dL
- has no allergic reaction to TCM
Key exclusion criteria (8 listed)
- below 20 years old
- ever drug abuse or still in drug abuse
- pregnant or in breast-feeding women
- with psychotic disorders
- cardiac arrhythmia with pacemaker
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 |
|---|---|---|
| PHY606Also: Danggui Buxue TangDanggui Buxue Tang is a well-known TCM formula indicated for anemia through immune modulation and increase energy metabolism | Drug | Healthy group, PHY606 |
Primary outcome
Constitution in Chinese Medicine Questionnaire (CCMQ)
Time frame: Change from baseline CCMQ at Day0, Day31, Day93 and Day180.
Serum Cytokines
Time frame: Change from baseline serum cytokines at Day0, Day31 and Day93.
Collect blood and measure the level of serum cytokines.
4 secondary outcomes
Tongue diagnosis
Time frame: Change from baseline tongue diagnosis at Day0 and Day93.
Pulse diagnosis
Time frame: Change from baseline Pulse diagnosis at Day0 and Day93.
Anemia blood test
Time frame: Change from baseline anemia blood at Day 0, Day 31 and Day93.
Genotype
Time frame: Change from baseline genotype at Day 0, Day 31 and Day93.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2021.
- Individual participant dataSharing planned: Undecided
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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.
Sheng-Teng Huang, MD PHD principal investigator
China Medical University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing PHY606 in people with Anemia and Herbal Interaction, run by Sheng-Teng Huang at 1 site in Taiwan.
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 2 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: finished, as of the sponsor's last update on 16 Aug 2021. 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 Taiwan. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Constitution in Chinese Medicine Questionnaire (CCMQ) (time frame: Change from baseline CCMQ at Day0, Day31, Day93 and Day180.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Aug 2021.