Nausea Clinical Trial
Official title:
ٍEffect of Iranian Traditional Medicine Remedy Compared With Placebo on Chemotherapy Induced Nausea and Vomiting in Breast Cancer; a Double-blind Randomized Controlled Cross-over Clinical Trial
Verified date | June 2016 |
Source | Mashhad University of Medical Sciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 69 |
Est. completion date | May 2016 |
Est. primary completion date | April 2016 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion criteria: - Clinical diagnosis of breast cancer, - Clinical diagnosis of chemotherapy induced nausea and vomiting resistant to conventional therapy. Exclusion Criteria: - Clinical diagnosis of hypersensitivity to Sumac or Bunium Persicum, - Clinical diagnosis of digestion disorders, - Clinical diagnosis of non chemotherapy induced nausea and vomiting, - Milk allergy, - Clinical diagnosis of bleeding diathesis, - Clinical diagnosis of non-breast cancer. |
Country | Name | City | State |
---|---|---|---|
Iran, Islamic Republic of | Department of Oncology, Imam Reza Hospital, Mashhad University of Medical Sciences | Mashhad | Khorasan Razavi |
Lead Sponsor | Collaborator |
---|---|
Mashhad University of Medical Sciences |
Iran, Islamic Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Secondary | 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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