Evaluation of the effect of Mocozift oral syrup (based on Trachyspermum ammi L) on reducing the failure of arteriovenous fistulas in the first 4 weeks after surgery in End Stage Renal Disease patients (ESRD).
Determination of the effect of Mocozift oral-herbal syrup (based on Trachyspermum Ammi L) on the failure rate of arteriovenous fistulas in the first 4 weeks after surgery in End-Stage Renal Disease patients (ESRD).
Design
Is a randomized, blinded, controlled clinical trial with a sample size of 160 patients in which randomized allocation is a Balanced block randomization.
Settings and conduct
The study will be performed in Hasheminejad Hospital and is a two-way blind. Patients, interveners and researchers are blinded in this study.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1. ESRD patients who have been diagnosed by a nephrologist as candidates for implantation of an arteriovenous fistula of the wrist (Cimino fistula).
2. Patients in whom Cimino fistula is performed for the first time.
3.Patients whose blood pressure range is more than 60/100 mm / Hg and less than 145/90 mm/Hg on the day of surgery.
4. Patients older than 18 years
Exclusion criteria:
1.Blood pressure below 100/60 mm/hg
2. Absence of a suitable vessel (helical vein or arterial atherosclerosis) or artery diameter less than 2 and vein diameter less than 2.5 mm
3. Patients who have used anticoagulants.
4.Their vascular system is prepared for Cimino fistula VA and is not suitable for radio cephalic VA.
5. Paralysis or ulceration of the organ where the fistula is to be implanted.
Intervention groups
From 2 weeks before the fistula implantation procedure and up to 2 weeks after surgery, the intervention group received 15 CC of Mocozift oral syrup daily, 15 minutes after each meal in three divided doses, and the control group received 15 CC of placebo syrup 15 minutes after each meal.
AVF=Arteriovenous Fistulas ESRD= End Stage Renal Disease
IRCT registration information
IRCT registration number:IRCT20180712040446N4
Registration date:2022-04-25, 1401/02/05
Registration timing:registered_while_recruiting
Last update:2022-04-25, 1401/02/05
Update count:0
Registration date
2022-04-25, 1401/02/05
Registrant information
Name
Atefe Sharif
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2247 3630
Email address
atf.sharif@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-03-02, 1400/12/11
Expected recruitment end date
2022-10-22, 1401/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of Mocozift oral syrup (based on Trachyspermum ammi L) on reducing the failure of arteriovenous fistulas in the first 4 weeks after surgery in End Stage Renal Disease patients (ESRD).
Public title
The effect of Mocozift syrup on the success of arteriovenous fistulas
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
ESRD patients who have been diagnosed by a nephrologist as candidates for implantation of an arteriovenous fistula on the wrist (Cimino fistula).
Patients whom Cimino fistula is performed for the first time.
Patients who blood pressure range is more than 60/100 mm / Hg or less than 145/90 mm/Hg on the day of surgery.
Patients older than 18 years
Exclusion criteria:
Blood pressure below 100/60 mm/Hg
Absence of a suitable vessel (helical vein or arterial atherosclerosis) or artery diameter less than 2 and vein diameter less than 2.5 mm
Patients who have used anticoagulants.
Their vascular system is prepared for Cimino fistula VA and is not suitable for radio cephalic VA.
Paralysis or ulceration of the organ where the fistula is to be implanted.
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
160
Randomization (investigator's opinion)
Randomized
Randomization description
Balance Block Randomization. In this method, random division is done in the form of "blocks" with a predetermined size. For example, if the size of block is 6, the random division operation takes place until the third person is randomly placed in one group, after which the individuals are automatically assigned to another group until the block of 6 is completed. The advantages of this method include the following: It is easy to implement and balance in the number of groups is guaranteed.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, both participants, researchers, and data analyzers are blinded
Placebo
Used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Iran University of Medical Sciences
Street address
Floor 13, Block A, Ministry of Health & Medical Education Headquarters, Between Zarafashan & South Falamak, Qods Town, Tehran, Iran.
City
tehran
Province
Tehran
Postal code
1449614535
Approval date
2022-02-09, 1400/11/20
Ethics committee reference number
IR.IUMS.FMD.REC.1400.634
Health conditions studied
1
Description of health condition studied
Increased success of arteriovenous fistulas of the wrist
ICD-10 code
N18. 6
ICD-10 code description
End Stage Renal Dieases
Primary outcomes
1
Description
Reduction of premature failure of arteriovenous fistulas of the wrist
Timepoint
6 weeks after surgery
Method of measurement
Observation and examination
2
Description
Accelerate the maturation of arteriovenous fistulas
Timepoint
2 weeks before and 2 weeks after surgery
Method of measurement
Observation and examination
Secondary outcomes
1
Description
Erythrocyte Sedimentation Rate
Timepoint
Before and after the intervention (weeks 0 and 6)
Method of measurement
Blood Test
2
Description
Blood Urea Nitrogen (BUN )
Timepoint
Before and after the intervention (weeks 0 and 6)
Method of measurement
Blood Test
3
Description
C Reactive Protein (CRP)
Timepoint
Before and after the intervention (weeks 0 and 6)
Method of measurement
Blood Test
4
Description
Creatinine (Cr)
Timepoint
Before and after the intervention (weeks 0 and 6)
Method of measurement
Blood Test
5
Description
White Blood Cell Count (WBC)
Timepoint
Before and after the intervention (weeks 0 and 6)
Method of measurement
Blood Test
6
Description
Blood Hemoglobin
Timepoint
Before and after the intervention (weeks 0 and 6)
Method of measurement
Blood Test
7
Description
Red Blood Cell Distribution Width (RDW)
Timepoint
Before and after the intervention (weeks 0 and 6)
Method of measurement
Blood Test
8
Description
Prothrombin Time (PT)
Timepoint
Before and after the intervention (weeks 0 and 6)
Method of measurement
Blood Test
9
Description
Partial Thromboplastin Time (PTT)
Timepoint
Before and after the intervention (weeks 0 and 6)
Method of measurement
Blood Test
10
Description
International Normalized Ratio (INR)
Timepoint
Before and after the intervention (weeks 0 and 6)
Method of measurement
Blood Test
11
Description
Ferritin
Timepoint
Before and after the intervention (weeks 0 and 6)
Method of measurement
Blood Test
Intervention groups
1
Description
Intervention group: The duration of treatment and follow-up for each patient will be a period of 6 weeks. From 2 weeks before the fistula implantation procedure and up to 2 weeks after surgery, the intervention group is given 15 CC of Mocozift oral syrup daily, 15 minutes after each meal in three divided doses. Mocozift oral syrup will be prepared without any label and drug information and only by entering a code from the pharmaceutical Company to the Blue Rain Seed. Mocozift oral syrup is licensed by the Ministry of Health and the Food and Drug Administration.
Category
Treatment - Drugs
2
Description
Control group: The control group will be given 15 CC placebo syrup 15 minutes after each meal in three divided doses. Placebo syrup will be prepared without any pharmaceutical label and information and only by entering a code from the pharmaceutical Company to the Blue Rain Seed.