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The main objective of this research is the role of the Persumac(an Iranian traditional remedy) on refractory Chemotherapy Induced Nausea and Vomiting (CINV) in breast cancer patients. Investigators assess effect of Persumac on the number/severity of nausea/ vomiting in acute and delayed phase.
The study was a double-blind, placebo controlled, Cross-over clinical trial of Iranian traditional remedy (Persumac) on chemotherapy induced nausea and vomiting in breast cancer patients. From October 2015 to May 2016, sample selection continued to be until the full sample size.
Executive steps of study:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| intervention | Active Comparator | 2.7 grams Persumac powder (Iranian traditional medicine remedy composed from sumac and Bunium Persicum) every 8 hour from 24 hour before to fifth day after chemotherapy. |
|
| control | Placebo Comparator | 2.7 grams Lactose every 8 hour from 24 hour before to fifth day after chemotherapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Persumac | Drug | 2.7 grams Persumac powder (Iranian traditional medicine remedy composed from sumac and Bunium Persicum) every 8 hour |
|
| Measure | Description | Time Frame |
|---|---|---|
| Frequency and Severity of nausea and vomiting in acute phase | number and severity of nausea and vomiting, acquired from questionnaire | first 24 hour after chemotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency and Severity of nausea and vomiting in acute phase | number and severity of nausea and vomiting, acquired from questionnaire | Day 2-5 of chemotherapy |
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Inclusion criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mohammad Nazari, Ph.D | School of Persian and Complementary medicine, Mashhad University of Medical Sciences, Mashhad, Iran | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Oncology, Imam Reza Hospital, Mashhad University of Medical Sciences | Mashhad | Razavi Khorasan Province | Iran |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28243404 | Derived | Nazari M, Taghizadeh A, Bazzaz MM, Rakhshandeh H, Shokri S. Effect of Persian Medicine Remedy on Chemotherapy Induced Nausea and Vomiting in Breast Cancer: A Double Blind, Randomized, Crossover Clinical Trial. Electron Physician. 2017 Jan 25;9(1):3535-3543. doi: 10.19082/3535. eCollection 2017 Jan. |
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Publication
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Aug 31, 2016 | |
| Reset | Oct 21, 2016 | |
| Release | Nov 1, 2016 | |
| Reset | Dec 28, 2016 | |
| Release | Jan 2, 2017 | |
| Reset | Feb 20, 2017 | |
| Release | Mar 29, 2017 | |
| Reset | Jun 14, 2017 | |
| Release | Jul 3, 2017 | |
| Reset | Feb 1, 2018 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Aug 31, 2016 | Oct 21, 2016 | |||
| Nov 1, 2016 |
| ID | Term |
|---|---|
| D009325 | Nausea |
| D014839 | Vomiting |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D007785 | Lactose |
| ID | Term |
|---|---|
| D004187 | Disaccharides |
| D009844 | Oligosaccharides |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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| lactose | Drug | 2.7 grams Lactose every 8 hour |
|
|
| Dec 28, 2016 |
| Jan 2, 2017 | Feb 20, 2017 |
| Mar 29, 2017 | Jun 14, 2017 |
| Jul 3, 2017 | Feb 1, 2018 |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D000073893 |
| Sugars |