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| Name | Class |
|---|---|
| Shahid Beheshti University of Medical Sciences | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Group A: patients receiving HB syrup, 10 cc three times daily |
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| Placebo | Placebo Comparator | Group B: patients receiving placebo, 10 cc three times daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| The change of mean score of Hemoglobin level of patients in intervention and placebo groups | 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. | The weeks of 0 and 4 after treatment |
| The change of mean score of WBC count of patients in intervention and placebo groups | 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. | The weeks of 0 and 4 after treatment |
| The change of mean score of Plt count of patients in intervention and placebo groups | 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. | The weeks of 0 and 4 after treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mehdi Pasalar | Shiraz University of Medical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shohaday-e- Tajrish Hospital | Tehran | Iran |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25777290 | Result | Pasalar M, Choopani R, Mosaddegh M, Kamalinejad M, Mohagheghzadeh A, Fattahi MR, Ghanizadeh A, Bagheri Lankarani K. Efficacy and safety of jollab to treat functional dyspepsia: a randomized placebo-controlled clinical trial. Explore (NY). 2015 May-Jun;11(3):199-207. doi: 10.1016/j.explore.2015.02.007. Epub 2015 Feb 17. | |
| 25587004 | Result |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| Pasalar M, Choopani R, Mosaddegh M, Kamalinejad M, Mohagheghzadeh A, Fattahi MR, Zarshenas MM, Jafari P, Lankarani KB. Efficacy of jollab in the treatment of depression in dyspeptic patients: a randomized double-blind controlled trial. J Evid Based Complementary Altern Med. 2015 Apr;20(2):104-8. doi: 10.1177/2156587214563542. Epub 2015 Jan 13. |
| 29743896 | Result | Emtiazy M, Oveidzadeh L, Habibi M, Molaeipour L, Talei D, Jafari Z, Parvin M, Kamalinejad M. Investigating the effectiveness of the Trigonella foenum-graecum L. (fenugreek) seeds in mild asthma: a randomized controlled trial. Allergy Asthma Clin Immunol. 2018 May 2;14:19. doi: 10.1186/s13223-018-0238-9. eCollection 2018. |
| 30858948 | Result | Taavoni S, Fathi L, Nazem-Ekbatani N, Haghani H. The Effect of Oral Intake of Honey Syrup on the Pain Intensity of Active Phase of Parturition of nulliparous women: A Randomized clinical trial. Caspian J Intern Med. 2019 Winter;10(1):98-101. doi: 10.22088/cjim.10.1.98. |
| D017437 |
| Skin and Connective Tissue Diseases |