Patients are randomly allocated into two experimental groups. In the group 1, the patients received D. Sophia powder (4 weeks) , then washout (2 weeks ) following by placebo( 4 weeks). In the group 2 as the same but in reverse direction. D. Sophia was prepared by admixing 2 g of D. Sophia powder and 0.5 g brown sugar. The placebo was prepared by combining 2 g starch powder and 0.5 g brown sugar.
Blood samples are drawn in four steps.
Study will be exicuted at Tehran Shahid modarres hospital and Babol Shahid Beheshti hospital.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age between 18 to 70 years old; being on hemodialysis for more than 3 months; KT/V > 1.2; Using AVF for Hemodialysis.
Non-inclusion criteria:
Sensitivity to D. Sophia or any herbal remedy; History of active infection in the past month; Unwillingness to participate in the study for any reason; Using permcath or AVG for hemodialysis; Hospital admission for any reason in past month or during the study period.
Intervention groups
The first intervention group (n = 30) initially received D. Sophia extract and received the placebo after the washout period.The second Intervention group (n = 30) received the placebo first and the post washout period,they recieved the D. Sophia extract placebo.
Shahid Beheshti University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 21 2208 3095
Email address
aalirezaei@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-22, 1397/10/01
Expected recruitment end date
2019-05-22, 1398/03/01
Actual recruitment start date
2019-01-05, 1397/10/15
Actual recruitment end date
2019-04-09, 1398/01/20
Trial completion date
2019-07-11, 1398/04/20
Scientific title
Evaluating the effects of Descurainia Sophia on serum inflammatory markers and thirst alleviation in hemodialysis patients
Public title
Descurainia Sophia in hemodialysis patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
age between 18 - 70 years old
on hemodialysis for more than 3 months
KT/V > 1.2
insensitive to D. Sophia or any herbal remedy
no history of active infection in the past month
using AVF for Hemodialysis
Exclusion criteria:
sensitivity to D. Sophia or any herbal remedy
history of active infection in the past month
unwilling to participate for any reason
using permcath or AVG for hemodialysis
hospital admission for any reason in past month and during the study period.
Age
From 18 years old to 70 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
60
More than 1 sample in each individual
Number of samples in each individual:
0
Actual sample size reached:
53
More than 1 sample in each individual
Actual sample size in each individual:
4
blood sample
Randomization (investigator's opinion)
Randomized
Randomization description
The method of balanced block randomization used with a block size of 4. For the allocation sequence, we applied computer-generated by random numbers. Medicines containing seed extract or placebos with the same shape and color numbered with a code in sealed envelopes. Each coded prepared medication with a label by one number from 1 to 60. The patients randomly allocated into two experimental groups: group 1(n=30) initially received Intervention D.S extract, and group2 (n=30 ) received placebo initially. Both groups were identical in terms of characteristics and comorbid conditions; the participants divided sequentially.The control group is assigned to "A" and the intervention group to "B", and then the two groups are divided into 6 blocks: (1) AAB, (2) B A A, (3 (B), b), b), b), b), b), b) These blocks are randomly put together by computer and provide a chain of randomized groups (eg: B A B B A B B A B B A B B). Then the patients enter these groups in order of entry.
Blinding (investigator's opinion)
Triple blinded
Blinding description
During study period ,a nurse coordinated the study and registered the study codes and the nurse handed the labeled drugs over participants and collected all the data. The patients , investigators , laboratory staffs and supervisers all were blinded to treatment assignment and lab data measurements during the study.
Placebo
Used
Assignment
Crossover
Other design features
prevention
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahid Beheshti University of Medical Sciences
Street address
7th Floor, Bldg No.2 , Shahid Beheshti University of Medical Sciences, Arabi Ave, Daneshjoo Blvd, Velenjak, chamran highway,Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
19839-63113
Approval date
2018-12-22, 1397/10/01
Ethics committee reference number
IR.SBMU.RETECH.REC.1397.299
Health conditions studied
1
Description of health condition studied
hemodialysis patients
ICD-10 code
N18.5
ICD-10 code description
Chronic kidney disease, stage 5
Primary outcomes
1
Description
MDA (Malondialdehyde)
Timepoint
At the start of the study, before wash out, after wash out and at the end of the study
Method of measurement
serum level and biochemistry analysis
2
Description
Potassium serum level
Timepoint
At the start of the study, before wash out, after wash out and at the end of the study
Method of measurement
blood sample
3
Description
Lipid profile
Timepoint
At the start of the study, before wash out, after wash out and at the end of the study
Method of measurement
blood sample
4
Description
Total antioxidation capacity
Timepoint
At the start of the study, before wash out, after wash out and at the end of the study
Method of measurement
blood sample
5
Description
Hemocystein serum level
Timepoint
At the start of the study, before wash out, after wash out and at the end of the study
Method of measurement
blood sampling
Secondary outcomes
1
Description
Thirst intensity
Timepoint
At the start of the study, before wash out, after wash out and at the end of the study
Method of measurement
using Visual Analogue Scale
Intervention groups
1
Description
The first intervention group (n = 30) initially received an extract of Descuria.Sophia containing 2 grams of D,Sophia powder and half a gram of brown sugar with 100 cc of water for 4 weeks, and after 2 weeks of washout period and followd by 4 weeks of placebo intake containing 2 grams of Starch powder and half a gram of brown sugar with 100 cc water.
Category
Treatment - Drugs
2
Description
Control group: The second intervention group (30 patients). At first,recieved 4 weeks of the placebo containing 2 grams of starch powder and half a gram of brown sugar with 100 cc of water, and after 2 weeks of washout period, followed by recieving Descuiria.Sophia extract containing 2 grams of D.Sophia powder and half a gram of brown sugar received with 100 cc water for 4 weeks.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Modaress hospital of Tehran
Full name of responsible person
Amirhesam Alirezaei
Street address
Shahid Modaress hospital , Kaaj square , Saadat Abad , Tehran