Development of PHY606 as Adjunct Therapy for Anemia Patients

NCT ID: NCT04974073

Last Updated: 2021-08-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-22
• Study Completion Date: 2019-11-18

Brief 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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

control group

with traditional western medicine treatment based on underlined disease

Group Type: NO_INTERVENTION

No interventions assigned to this group

PHY606

PHY606 7.5gm BID for 3 months

Group Type: EXPERIMENTAL

PHY606

Intervention Type: DRUG

Danggui Buxue Tang is a well-known TCM formula indicated for anemia through immune modulation and increase energy metabolism

Healthy group

PHY606 7.5gm BID for 2 days

Group Type: OTHER

PHY606

Intervention Type: DRUG

Danggui Buxue Tang is a well-known TCM formula indicated for anemia through immune modulation and increase energy metabolism

Interventions

PHY606

Danggui Buxue Tang is a well-known TCM formula indicated for anemia through immune modulation and increase energy metabolism

Intervention Type: DRUG

Other Intervention Names

Danggui Buxue Tang

Eligibility Criteria

Inclusion Criteria

• female: Hb<11 g/dL; male: Hb<13.5 g/dL
• has no allergic reaction to TCM

Exclusion Criteria

• 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sheng-Teng Huang

OTHER

Sponsor Role: lead

Responsible Party

Sheng-Teng Huang

Attending Physician

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Sheng-Teng Huang, MD PHD

Role: PRINCIPAL_INVESTIGATOR

China Medical University Hospital

Locations

China Medical University Hospital

Taichung, , Taiwan

Countries

Taiwan

Other Identifiers

CMUH106-REC3-028

Identifier Type: -

Identifier Source: org_study_id