Buxue Yimu Pills for Gynecological Iron-Deficiency Anemia

Phase 2

• Conditions: Iron-Deficiency Anemia
• Interventions: Drug: Buxue Yimu Pills; Drug: Buxue Yimu Pills &Ferrous Sulfate; Drug: Ferrous Sulfate

• Registration Number: NCT03232554
• Lead Sponsor: Peking Union Medical College Hospital

Brief 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 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 Timeline

• Study Start: 2017-06-01
• Study First Submitted: 2017-07-08
• Study First Submitted QC: 2017-07-26
• Study First Posted: 2017-07-28
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-10
• Last Update Posted: 2018-02-13
• Primary Completion: 2018-12-31
• Study Completion: 2019-02-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 180

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Buxue Yimu Pills	Buxue Yimu Pills	Buxue Yimu Pill 12g pill by mouth, twice daily
Buxue Yimu Pills &Ferrous Sulfate	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
Ferrous Sulfate	Ferrous Sulfate	Ferrous Sulfate 0.3g tablet by mouth, three times daily

Primary Outcome Measures

Name	Time	Method
Complete Blood Count	5 minutes	Anemia Related Assessment

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Lei Li; 🇨🇳 Beijing, Beijing, China