Breast Cancer Clinical Trial
Official title:
Honey Based Syrup on Blood Parameters
Study aim Determination of the effect of a honey based (HB) syrup on the blood parameters of
patients with breast cancer Design Two arm parallel group randomised clinical trial, double
blinded Settings and conduct Design of the study: Women patients with breast cancer referring
to Shohaday-e- Tajrish Hospital of Tehran who are under chemotherapy treatment. In order to
blind the investigator, medications are named as "A" for syrup of HB and B for placebo. The
patients don't aware of the type of drug they are assigned to. In addition, the groups are
entered into statistical analysis as "A" and "B.
The patients will revive either A or B syrup for 4 weeks. At the beginning of the trial
demographic data would be gathered. Also, a blood sample would be drawn at the beginning time
and after the end of intervention period (week 4).
Data would be analysed by SPSS software using T-test.
Women patients with breast cancer referring to Shohaday-e- Tajrish Hospital of Tehran who are
under chemotherapy treatment. In order to blind the investigator, medications are named as
"A" for syrup of HB and B for placebo. The patients don't aware of the type of drug they are
assigned to. In addition, the groups are entered into statistical analysis as "A" and "B.
The patients will revive either A or B syrup for 4 weeks. At the beginning of the trial
demographic data would be gathered. Also, a blood sample would be drawn at the beginning time
and after the end of intervention period (week 4).
Data would be analysed by SPSS software using T-test. Main outcome variables The mean of
score of "Hemoglobine (Hb)", 2. The mean of score of "white blood cell count (WBC)", 3. The
mean of score of "platelet count (Plt)"
Main outcome variables The mean of score of "Hemoglobine (Hb)", 2. The mean of score of
"white blood cell count (WBC)", 3. The mean of score of "platelet count (Plt)"
Participants/Inclusion and exclusion criteria Inclusion criteria: women suffer from breast
cancer who are; 1.Age between 18- 70 years old; 2. Hemoglobin level is at least 8g/dl; 3.
Hematocrit level at least 30%; 4. normal TSH. Exclusion criteria: 1. Heart disease with
unstable conditions; 2. Disabling Pulmonary Disease and History of Asthma; 3. Severe kidney
disease; 4. Creatinine level greater than 2mg/dl; 5. Proteinuria; 6. The SGOT level more than
3 times of the normal threshold; 7. Bilirubin levels greater than 2mg/dl; 8. Positive history
of hypersensitivity to saffron, rose water and honey; 9. severe infection; 10. Systemic
disease;11. Positive history of gout or high level of uric acid; 12. An individual who uses
antidepressants due to depression; 13. Simultaneous use of drugs that affect fatigue; 14.
Uncontrolled pain; 15. Unwillingness to participate in the study.
;
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