Clinical trial NCT03232554: Buxue Yimu Pills for Gynecological Iron-Deficiency Anemia
Official title: Clinical Observation of The Gynecological Iron-Deficiency Anemia Treated With Buxue Yimu Pills
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Iron-Deficiency Anemia
Keywords: Iron-Deficiency Anemia
Buxue Yimu Pills
Ferrous Sulfate
clinical observations
adult women
Metabonomics
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2017-07-28
Enrollment: 180
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Complete Blood Count
timeFrame: 5 minutes
Secondary outcomes:
measure: The Short Form-36 Health Survey (Sf-36)
timeFrame: 10 minutes
measure: Hepatic Function
timeFrame: 5 minutes
measure: Renal Function
timeFrame: 5 minutes
measure: Blood Glucose
timeFrame: 5 minutes
measure: Electrolyte Semiconductor Junction
timeFrame: 5 minutes
measure: Electrocardiogram(ECG)
timeFrame: 5 minutes
measure: Iron Metabolism index
timeFrame: 5 minutes
Other outcomes:
measure: Metabonomics Measurement
timeFrame: 1hour
Locations:
city: Beijing
country: China
facility: Lei Li
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital, Chinese Academy of Medicine Sciences
name: Aijun AJ Sun, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.