Evaluation of the protective effect of Curcuma Longa against cisplatin induced nephrotoxicity in patients with cancer
Design
Clinical trial with a control group, with parallel groups, one-way blind, randomized, on 30 patients (2 groups of 15 people). Patients are allocated randomly with simple sequential allocation in one of the two study groups by help of sealed envelope.
Settings and conduct
This study will be performed as a clinical trial in Kosar Hospital in Semnan. Patients are unaware of the intervention groups. Variables are measured before starting cisplatin treatment and also at 5 and 21 days after starting cisplatin treatment.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age 18-60 years; Confirmation of cancer by a specialist doctor; The disease should be such that the use of cisplatin as a treatment is approved by a specialist doctor.
Exclusion criteria: The patient has a previous kidney disease (GFR is low from the beginning); Existence of underlying diseases such as diabetes, hypertension, etc. in the patient; Increased creatinine indicated for discontinuation of the drug.
Intervention groups
Intervention group: In addition to routine treatments, this group consumes one turmeric tablet of "Dineh Iran" company (Each tablet contains 450 mg of turmeric rhizome powder and 50 mg of turmeric extract, which is standardized based on 5.47 mg of curcumin) with lunch 3 days before the start of cisplatin treatment.
Control group: This group only receives routine treatments.
Semnan University of Medical Sciences, Semnan, Iran
Country
Iran (Islamic Republic of)
Phone
+98 23 3345 1336
Email address
are20935@semums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-06, 1400/09/15
Expected recruitment end date
2022-02-04, 1400/11/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the protective effect of Curcuma Longa against cisplatin induced nephrotoxicity in patients with cancer
Public title
Evaluation of the protective effect of Curcuma Longa induced nephrotoxicity in patients with cancer
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18-60 years
Confirmation of cancer by a specialist doctor
The disease should be such that the use of cisplatin as a treatment is approved by a specialist doctor
Exclusion criteria:
The patient has a previous kidney disease (GFR is low from the beginning)
Existence of underlying diseases such as diabetes, hypertension, etc. in the patient
Increased creatinine indicated for discontinuation of the drug
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Numbers 1 to 30 are written on paper and all of them are placed in sealed envelopes. Patients are then asked to select an envelope each. Patients whose number in the envelope is odd will be in the intervention group and patients whose number in the envelope is even will be in the control group.
Blinding (investigator's opinion)
Single blinded
Blinding description
Drug packaging is coded. So that the patients are unaware of the drug content packaging and intervention that they receive.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Semnan University of Medical Sciences
Street address
Semnan University of Medical Sciences, Basij Blvd, Semnan
City
Semnan
Province
Semnan
Postal code
3514799442
Approval date
2020-10-27, 1399/08/06
Ethics committee reference number
IR.SEMUMS.REC.1399.218
Health conditions studied
1
Description of health condition studied
Cisplatin induced nephrotoxicity
ICD-10 code
N17.9
ICD-10 code description
Acute kidney failure, unspecified
Primary outcomes
1
Description
Blood creatinine level
Timepoint
Before starting treatment with Cisplatin and 5 and 21 days after starting treatment with Cisplatin
Method of measurement
Biorexfars Laboratory Diagnostic Kit
2
Description
BUN(Blood Urea Nitrogen) level
Timepoint
Before starting treatment with Cisplatin and 5 and 21 days after starting treatment with Cisplatin
Method of measurement
Biorexfars Laboratory Diagnostic Kit
3
Description
Creatinine Clearance level
Timepoint
Before starting treatment with Cisplatin and 5 and 21 days after starting treatment with Cisplatin
Method of measurement
Through Up-to-date software and using the CKD-EPI formula
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In addition to routine treatments, this group consumes one turmeric tablet of "Dineh Iran" company (Each tablet contains 450 mg of turmeric rhizome powder and 50 mg of turmeric extract, which is standardized based on 5.47 mg of curcumin) with lunch 3 days before the start of cisplatin treatment.
Category
Treatment - Drugs
2
Description
Control group: This group only receives routine treatments
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Kowsar Hospital
Full name of responsible person
Seyed Ali Madani Lamraski
Street address
Street Amin, Semnan
City
Semnan
Province
Semnan
Postal code
3519899951
Phone
+98 23 3345 1336
Email
are20935@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Parviz Kokhaei
Street address
Semnan University of Medical Sciences, Basij Blvd, Semnan.
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
p_kokha@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Mohammad Amir Sarabi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Hematology
Street address
Street Amin, Semnan
City
Semnan
Province
Semnan
Postal code
3519899951
Phone
+98 23 3345 1336
Email
are20935@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Mohammad Amir Sarabi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Hematology
Street address
Street Amin, Semnan
City
Semnan
Province
Semnan
Postal code
3519899951
Phone
+98 23 3345 1336
Email
are20935@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Mohammad Amir Sarabi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Hematology
Street address
Street Amin, Semnan
City
Semnan
Province
Semnan
Postal code
3519899951
Phone
+98 23 3345 1336
Email
are20935@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available