Effects a Honey Based Syrup on Blood Parameters in Patients With Breast Cancer

• Status: Completed
• Trial end date: 2020-10-05
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shiraz University of Medical Sciences
• Collaborator: Shahid Beheshti University of Medical Sciences

Criteria

Inclusion Criteria:

• Female gender

• Age between 18- 70 years old Patients

• known case of breast cancer

• Hemoglobin level is at least 8 g / dl

• Hematocrit level at least 30% The level of

• TSH is normal

Exclusion Criteria:

• Patients known case of heart disease with unstable conditions

• Disabling Pulmonary Disease and History of Asthma

• Patients known case of severe kidney disease (Creatinine level is greater than 2mg / dl Proteinuria)

• The SGOT level is more than 3 times of the normal threshold

• Bilirubin levels is greater than 2mg / dl

• Positive history of hypersensitivity to saffron, Rose water and Honey

• Uncontrolled pain

• severe infection

• serious illness

• Positive history of gout or high level of uric acid

• An individual who uses antidepressants due to depression

• Simultaneous use of drugs that affect blood cells

• Unwillingness to participate in the study

• Active treatment for anemia (transfusion or Epoetin Alfa Injection)