Clinical Observation of The Gynecological Iron-Deficiency Anemia Treated With Buxue Yimu Pills
Phase: PHASE2
Conditions: Iron-Deficiency Anemia
Sponsor: Peking Union Medical College Hospital

Clinical	  Observation	  Of	  The	  Gynecological	  
Iron-­‐‑Deficiency	  Anemia	  Treated	  With	   	  
Buxue	  Yimu	  Pills	  
Version	  2（June,2017）	  

CONTENTS	  
	  
	  
A.   OBJECT	  
B.   STUDY	  METHOD	  AND	  DESIGN	  
C.   TECHNICAL	  ROUTE	  
D.   STATISTICS	  ANALYSIS	  
E.   QUALITY	  CONTROL	  MEASUREMENT	  AND	  RESULT	  
PUBLICATION	  
F.   SOURCE(S)	  OF	  FUNDING	  
	  
	  
	  
	  
	  
	  
	  
	  
	  
	  
	  
	  

A.   OBJECT	  
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.	  	  
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	  
adult	  women,	  with	  the	  object	  to	  perform	  clinical	  efficacy	  and	  safety	  assessment.	  
In	  addiction,	  we	  expect	  to	  conduct	  research	  on	  its	  metabonomics,	  trying	  to	  probe	  
into	  the	  mechanism	  and	  pharmacodyamic	  material	  basis	  of	  this	  mysterious	  
traditional	  Chinese	  medicine.	  
	  
B.   STUDY	  DESIGN	  AND	  METHOD	  
－STUDY	  DESIGN:	  180	  women	  with	  mild	  to	  moderate	  Iron	  Deficiency	  Anemia	  
were	  observed	  in	  a	  prospective	  multi-­‐‑center	  randomized	  controlled	  clinical	  trial.	  
	   	   	   Inclusion	  Criteria:	  
1.   Subject	  is	  a	  female	  between	  the	  age	  of	  18	  and	  50.	  
2.   Subject	  suffers	  from	  mild	  to	  moderate	  anemia	  with	  a	  hemoglobin	  between	  
80g/L	  and	  110	  g/L.	  
3.   Subject	  has	  definite	  gynecological	  etiological	  factors	  of	  iron	  deficiency	  
4.   Subject	  provides	  written	  informed	  consent.	  
	   	   	   	   Exclusion	  Criteria:	  
1.   Subject	  underwent	  chronic	  digestive	  tract	  inflammation,	  uncontrolled	  
digestive	  or	  urinary	  system	  bleeding.	  
2.   Subject	  has	  other	  complications	  in	  addition	  to	  gynecological	  diseases	  leading	  
to	  iron	  deficiency,	  such	  as	  hemorrhagic	  diseases	  of	  hematologic	  system,	  
parasitic	  diseases	  like	  ancylostomiasi,	  chronic	  intravascular	  hemolysis,	  
mechanical	  hemolysis	  like	  prosthetic	  valve,renal	  dysfunction	  and	  
hemodialysis.	  
3.   Subject	  is	  pregnant	  or	  lactating.	  
4.   Subject	  has	  a	  severe	  systemic	  disease,	  such	  as	  cardiovascular	  system	  
5.   Subject	  has	  a	  history	  of	  malignancy	  or	  radiotherapy.	  
6.   Subject	  has	  undergone	  any	  Iron	  deficiency	  anemia	  treatment	  including	  Iron	  
supplements	  or	  blood	  transfusion	  within	  1month	  prior	  to	  randomization.	  
7.   Subject	  has	  mental	  disorder	  incapable	  of	  elementary	  cooperations.	  
8.   Subject	  has	  participated	  in	  other	  clinical	  researches	  of	  medicine	  within	  
1month	  prior	  to	  randomization.	  

－METHODS: The	  participants	  were divided	  randomly	  into	  3	  groups:	   	  
a.   Experimental	  group1(60	  patients):	  Buxue	  Yimu	  Pills	  12g	  pill	  by	  mouth,	  twice	  
daily.	   	  
b.   Experimental	  group2(60	  patients): Buxue	  Yimu	  Pills	  12g	  pill	  by	  mouth,	  twice	  
daily	  and	  Ferrous	  Sulfate	  0.3g	  tablet	  by	  mouth,	  three	  times	  daily.	  
c.   Active	  Comparator	  group	  (60	  patients): Ferrous	  Sulfate	  0.3g	  tablet	  by	  mouth,	  
three	  times	  daily.	  
－TREATMENT	  PERIOD:	  1month.	  
－OUTCOMES	  MEASUREMENT：	  
Primary	  
Outcome	  
(Anemia	  
Related	  
Assessment,	  
Clinical	  
Efficacy	  
Assessment):	   Complete	   Blood	   Count,	   Urine	   Routine,	   Reticulocyte	   Count,	   Iron	  
Metabolism	   index	   (Serum	   Iron,	   Total	   Iron	   Binding	   Capacity,	   Serum	   Ferritin),	  
Coagulation	  
Indexes	  
(Activated	  
Partial	  
Thromboplastin	  
Time,	  
APTT),	  
Prothrombin	  Time	  (PT),	  Fibrinogen	  (FIB),	  Thrombin	  Time(TT), The	  Short	  Form-­‐‑
36	  Health	  Survey	  (Sf-­‐‑36).	  
Secondary	   Outcome	   (Safety	   Assessment):	   Hepatic	   Function,	   Renal	   Function,	  
Blood	  Glucose,	  Electrolyte	  Semiconductor	  Junction,	  Electrocardiogram(ECG)	  
Other	  Pre-­‐‑Specified	  Outcome	  (Metabonomics	  Assessment):	  Build	  up	  a	  new	  
therapeutic	   evaluation	   system	   about	   Buxue	   Yimu	   Pills	   in	   the	   treatment	   of	  
Gynecological	  Iron-­‐‑Deficiency	  Anemia,	  which	  integrating	  clinical	  information	  with	  
metabonomics,	  to	  probe	  into	  the	  mechanism	  and	  pharmacodyamic	  material	  basis	  
of	  this	  mysterious	  traditional	  Chinese	  medicine.	  
C.   TECHNICAL	  ROUTE	  
Screening	  Period	  (Day	  -­‐‑30~0)	  
1.   We	  enrolled	  in-­‐‑patients	  according	  to	  the	  uniform	  inclusion/ exclusion	  
criteria	  above,	  and	  informed	  consent	  will	  be	  signed	  by	  all	  study	  participants	  
beform	  jioning	  in	  the	  study.	  
2.   Collect	  medical	  history	  and	  certain	  demographic	  features	  of	  every	  
participant,	  and	  peform	  general	  physical	  examination	  as	  well	  as	  gynecologic	  
physical	  examination.	  
3.   Complete	  outcomes	  measurement	  above.	  
4.   Make	  the	  appointment	  for	  the	  follow-­‐‑up.	  
The	  First	  Follow-­‐‑Up	  Period	  (Day	  -­‐‑30~0)	  

1.   Group	  randomly	  and	  distribute	  medicine	  and	  patient	  diary	  pamphlet.	  
2.   Inform	  application	  notice.	  
3.   Make	  the	  appointment	  for	  the	  next	  follow-­‐‑up.	  
The	  Second	  Follow-­‐‑Up	  Period(Day0~30)	  
1.   Collect	  medical	  history	  and	  certain	  demographic	  features	  of	  every	  
participant,	  and	  peform	  general	  physical	  examination	  as	  well	  as	  gynecologic	  
physical	  examination,	  again.	  
2.   Complete	  outcomes	  re-­‐‑measurement	  above.	  
3.   Take	  back	  the	  medicine	  and	  patient	  diary	  pamphlet.	  
D.   STATISTICS	  ANALYSIS	  
Data	  
was	  
analyzed	  
using	  
SPSS	  
Version	  
18.	  
All	  quantitative	  
informations	  are	  expressed	  as	  mean	  values	  ±	  standard	  deviation	  (SD).	   Statistical	  
significance	   was	   assessed	   using	   unpaired	   Student’s	   t-­‐‑test	   or	   chi-­‐‑square	   test.	  
Probability	  values	  of	  less	  than	  0.05	  were	  considered	  significant	  and	  an	  asterisk	  
identifies	  such	  significance	  in	  the	  figures.	  We	  will	  also	  compare	  the	  adverse	  effect	  
of	  each	  group	  using	  descriptive	  statistics.	  
E.   QUALITY	   CONTROL	   MEASUREMENT	   AND	   RESULT	  
PUBLICATION	  
1.   Every	  center	  of	  the	  research	  possesses	  the	  competence	  of	  scientific	  research	  
to	   conduct	   clinical	   studies. Special	   people	   from	   each	   center	   will	   be	   put	   in	  
charge	  of	  the	  research	  and	  monitoring	  the	  whole	  procedure.The	  rights	  and	  
interests，responsibility	  and obligation	  of	  all	  centers	  will	  be	  standardized	  with	  
the	  research	  agreement.	  
2.   The	   maintenance,	   secrecy	   and	   safety	   of	   data	   and	   informations	   will	   be	  
guaranteed	  by	  Department	  of	  Obsterics	  and	  Gynecology,	  Peking	  Union	  Medical	  
College	  Hospital.	  
3.   Every	  center	  is	  responsible	  to	  subject	  enrollment	  and	  finish	  the	  prospective 
follow	  up.	  
4.   The	  researchers'	  findings	  will	  be	  released	  in	  a	  paper	  published	  online.	  
	  
F.   SOURCE(S)	  OF	  FUNDING	  
1.  
This study does not charge any fee to any patients. 
2.  
All the investigational drugs and cost of the study are provided by Qian Jin 
Pharmaceutical CO., LTD.