Determining the effect of Pardihan syrup on platelet count; Determining the effect of Pardihan syrup on hemoglobin
Design
This study is a double-blind, randomized, placebo-controlled clinical trial on 32 patients with thrombocytopenia in the clinic of Mostafa Khomeini Hospital. Laboratory tests are used to diagnose thrombocytopenia.32 codes were randomized with Excel software
Settings and conduct
Patients with a history of thrombocytopenia are referred for testing of blood samples by experienced staff of Mostafa Khomeini Hospital. The consent form of participation in the research project is also completed by patients. Relevant questionnaires are completed. Pardihan and placebo are provided by the manufacturer with similar containers. Special codes are inserted on the package that will be kept confidential until the end of the study. So that the project partners will not be aware of the internal content of the drug packaging. Patients received the number and entered the study in order.
Take one tablespoon every 8 hours for 4 weeks.At the beginning of the study and after 2, 4 and 6 weeks, the blood sample is taken again by the staff and the test results are checked by the treating physician.The quality of life questionnaire will be completed again at the end of the study.
Participants/Inclusion and exclusion criteria
Inclusion criteria
All patients with a diagnosis of thrombocytopenia; Signing a informed consent form; over the age of 18
exclusion criteria
Patients with severe platelet depletion who are taking Nplate; have allergic to medicinal plants.
Intervention groups
Pardihan Group as a medicine has a license from the Food and Drug Administration of the country No. 90234/665
The control group was prepared as a placebo with the same appearance of the drug but safe by pharmacists.
Main outcome variables
platelet count
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20081024001391N3
Registration date:2021-06-09, 1400/03/19
Registration timing:registered_while_recruiting
Last update:2021-06-09, 1400/03/19
Update count:0
Registration date
2021-06-09, 1400/03/19
Registrant information
Name
Mohsen Naseri
Name of organization / entity
Shahed University
Country
Iran (Islamic Republic of)
Phone
+98 21 6646 4320
Email address
naseri@shahed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-09, 1400/01/20
Expected recruitment end date
2022-03-06, 1400/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of “Pardihan” syrup on platelet count: a randomized double-blind placebo controlled clinical trial
Public title
Effect of “Pardihan” syrup on platelet count
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients with a diagnosis of thrombocytopenia
Signing a informed consent form
Age over 18 years
Exclusion criteria:
History of allergy to medicinal plants components
Use of nplate drug
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:
32
Randomization (investigator's opinion)
Randomized
Randomization description
Eligible participants will be randomly assigned into 2 groups in a 1:1 ratio using block randomization method with a block length of 2 by PROC PLAN of SAS 9.4. An independent statistician generates the randomization number sequence. The drug codes will be attached after the manufacturing and packaging of the experiment treatment and placebo. Then, allocation concealment will be done using the SNOSE method. The drugs will be allocated sequentially according to the screening order of the patients. Group assignment will be kept in an opaque and sealed envelope and will be opened after data analysis by another statistician.
Blinding (investigator's opinion)
Double blinded
Blinding description
The coding is done in two groups and placebo by a person who does not interfere in the plan and keeps the codes confidential. Until the end of the study, the researcher, doctor and project colleagues are not aware of it. The medicine and the placebo are similar in appearance, packaging, color and smell.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahed University
Street address
Shahed University, In front of the holy of Imam,Persian Gulf Highway,
City
Tehran
Province
Tehran
Postal code
3319118651
Approval date
2020-06-29, 1399/04/09
Ethics committee reference number
IR.SHAHED.REC.1399.053
Health conditions studied
1
Description of health condition studied
Patients with thrombocytopenia
ICD-10 code
D69.6
ICD-10 code description
Thrombocytopenia, unspecified
Primary outcomes
1
Description
platelet counts and hemoglobin
Timepoint
Take the drug for 4 weeks. Measurements are taken after 2, 4 and 6 weeks.
Method of measurement
Blood test (CBC)
Secondary outcomes
1
Description
Quality of Life
Timepoint
Before starting the study; After 6 weeks (end of study)
Method of measurement
World Health Organization Quality of Life Questionnaire 26 questions
Intervention groups
1
Description
Intervention group: Pardihan medicine is a combination of grape juice, apple and basil produced by Sanabel Daroo Company with a license from the Food and Drug Administration of the country No. 90234/665 in January 2016. Take one tablespoon every eight hours for up to 4 weeks.In addition to medication, patients also receive their routine treatments including folic acid and B12 ampules.
Category
Treatment - Drugs
2
Description
Control group: The placebo is provided by Sanabel Daroo Company. Take one tablespoon every eight hours for up to 4 weeks.In addition to placebo patients receive their routine treatments including folic acid and B12 ampules.
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahed University
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
Shahed University
Full name of responsible person
Mohsen Naseri
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
No. 1471, Headquarters of Shahed University Research Centers,North Kargar St. Enghlab square
City
Tehran
Province
Tehran
Postal code
1417953836
Phone
+98 21 6646 4320
Email
naseri@shahed.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahed University
Full name of responsible person
Mohsen Naseri
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
No. 1471,Headquarters of Shahed University Research Centers, North Kargar St. Enghlab square
City
Tehran
Province
Tehran
Postal code
1417953836
Phone
0098216646432021
Email
naserishahed@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahed University
Full name of responsible person
Mohsen Naseri
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
No. 1471,Headquarters of Shahed University Research Centers, North Kargar St. Enghlab square
City
Tehran
Province
Tehran
Postal code
1417953836
Phone
+98 21 6646 4320
Email
naseri@shahed.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Participant Data File (IPD): After identifying individuals, the analysis data will be presented.
Study Protocol: Published as an article.
Clinical study report: published as an article.
When the data will become available and for how long
6 months after printing the results in the form of an article
To whom data/document is available
Researchers working in institutions and individuals in the industrial sector can apply to a scientific respondent
Under which criteria data/document could be used
It is possible to use the documents after publishing the extracted article with a scientifically responsive opinion.
From where data/document is obtainable
Email:
naseri@shahed.ac.ir
naserishahed@yahoo.com
What processes are involved for a request to access data/document
The email will be reviewed by the applicant at least two days after the application is sent and will be answered within a week.