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Completed

NCT Number: NCT04426435

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

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Shohaday-e- Tajrish Hospital

Tehran, Iran

About this 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. 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

honey based (HB) syrup

Drug

honey-based syrup is prepared according to the documented Persian Medicine manuscripts with some modifications. HB is a mixture of honey, rose water and saffron. Each 100g of HB consisted of 79.87 g honey, 19.97 g rose water, and 0.16 g saffron.

All the ingredients were licensed and approved by The Islamic Republic of Iran Food and Drug Organization (I.R.I.FDO).

Primary outcomes

  1. The change of mean score of Hemoglobin level of patients in intervention and placebo groups

    Time frame: The weeks of 0 and 4 after treatment

    A mean score of hemoglobin level is generally defined as 12.5 to 14.5 grams per deciliter (125-145 grams per liter) for women. Higher or lower scores mean a worse outcome.

  2. The change of mean score of WBC count of patients in intervention and placebo groups

    Time frame: The weeks of 0 and 4 after treatment

    A mean score of WBC count is usually between 4,000 and 11,000 per microliter of blood for women. Higher or lower scores mean a worse outcome.

  3. The change of mean score of Plt count of patients in intervention and placebo groups

    Time frame: The weeks of 0 and 4 after treatment

    A mean score of Plt count is usually ranges from 150,000 to 450,000 platelets per microliter of blood for women. Higher or lower scores mean a worse outcome.

Sponsors and collaborators

Lead sponsor

Shiraz University of Medical Sciences

Other

Collaborators

  • Shahid Beheshti University of Medical Sciences

Registry information

Official study title

Honey Based Syrup on Blood Parameters

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jun 11, 2020
Registry last updated
Oct 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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