Buxue Yimu Pills for Gynecological Iron-Deficiency Anemia (BXYMIDA)

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.

Study Overview

• Status: Unknown
• Conditions: Iron-Deficiency Anemia
• Intervention / Treatment: Drug: Buxue Yimu Pills; Drug: Buxue Yimu Pills &Ferrous Sulfate; Drug: Ferrous Sulfate

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 Type: Interventional
• Enrollment (Anticipated): 180
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 10000
      • Recruiting
      • Lei Li
      • Contact: Lei L Li, MD; Phone Number: +86 13911988831; Email: lileigh@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Buxue Yimu Pills; Buxue Yimu Pill 12g pill by mouth, twice daily	Drug: Buxue Yimu Pills; Buxue Yimu Pills 12g pill by mouth, twice daily.; Other Names: Buxue Yimu pellets
Experimental: Buxue Yimu Pills &Ferrous Sulfate; Buxue Yimu Pill 12g pill by mouth, twice daily and Ferrous Sulfate 0.3g tablet by mouth, three times daily	Drug: Buxue Yimu Pills &Ferrous Sulfate; Buxue Yimu Pills 12g pill by mouth, twice daily and Ferrous Sulfate 0.3g tablet by mouth, three times daily; Other Names: Buxue Yimu pellets,Iron Sulfate
Active Comparator: Ferrous Sulfate; Ferrous Sulfate 0.3g tablet by mouth, three times daily	Drug: Ferrous Sulfate; Ferrous Sulfate 0.3g tablet by mouth, three times daily; Other Names: Iron Sulfate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete Blood Count	Anemia Related Assessment	5 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Short Form-36 Health Survey (Sf-36)	Information about health	10 minutes
Hepatic Function	Safety Monitoring	5 minutes
Renal Function	Safety Monitoring	5 minutes
Blood Glucose	Safety Monitoring	5 minutes
Electrolyte Semiconductor Junction	Safety Monitoring	5 minutes
Electrocardiogram(ECG)	Safety Monitoring	5 minutes
Iron Metabolism index	Anemia Related Assessment	5 minutes

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Metabonomics Measurement	Extensive and profound Information	1hour

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital
• Investigators: Principal Investigator: Aijun AJ SUN, MD, Peking Union Medical College Hospital, Chinese Academy of Medicine Sciences

Publications and helpful links

General 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.
• Seid 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.
• Wang 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.

Helpful Links

• Ferric Carboxymaltose as Treatment in Women with Iron-Deficiency Anemia.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2017
• Primary Completion (Anticipated): December 31, 2018
• Study Completion (Anticipated): February 28, 2019

Study Registration Dates

• First Submitted: July 8, 2017
• First Submitted That Met QC Criteria: July 26, 2017
• First Posted (Actual): July 28, 2017

Study Record Updates

• Last Update Posted (Actual): February 13, 2018
• Last Update Submitted That Met QC Criteria: February 10, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: Metabonomics; Iron-Deficiency Anemia; Buxue Yimu Pills; Ferrous Sulfate; clinical observations; adult women
• Additional Relevant MeSH Terms: Metabolic Diseases; Hematologic Diseases; Nutrition Disorders; Anemia, Hypochromic; Iron Metabolism Disorders; Malnutrition; Anemia, Iron-Deficiency; Anemia; Deficiency Diseases; Physiological Effects of Drugs; Trace Elements; Micronutrients; Iron
• Other Study ID Numbers: IDA201706

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Network platform, and the website will be attached later.
• IPD Sharing Time Frame: Within 2 months after the trial complete
• IPD Sharing Access Criteria: Data access requests will be reviewed by an external independent review panel.Requestors will be required to sign a Data Access Agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No