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IRCT20081024001391N3 IRCT 2021-06-09 Shahed University Effect of “Pardihan” syrup on platelet count Effect of “Pardihan” syrup on platelet count: a randomized double-blind placebo controlled clinical trial 2021-04-09 anticipated 32 Complete https://irct.ir/trial/54053 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, 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 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. 3 Patients with thrombocytopenia. Intervention 1: 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. Intervention 2: 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. Yes - There is a plan to make this available What will be shared: 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: 6 months after printing the results in the form of an article To whom: Researchers working in institutions and individuals in the industrial sector can apply to a scientific respondent Conditions: It is possible to use the documents after publishing the extracted article with a scientifically responsive opinion. Where to obtain: Email: naseri@shahed.ac.ir naserishahed@yahoo.com How to obtain: The email will be reviewed by the applicant at least two days after the application is sent and will be answered within a week. Comments:
public Mohsen Naseri
No. 1471, Headquarters of Shahed University Research Centers,North Kargar St. Enghlab square
Tehran Iran (Islamic Republic of) 1417953836 +98 21 6646 4320 naseri@shahed.ac.ir Shahed University scientific Mohsen Naseri
No. 1471,Headquarters of Shahed University Research Centers, North Kargar St. Enghlab square
Tehran Iran (Islamic Republic of) 1417953836 0098216646432021 naserishahed@yahoo.com Shahed University Iran (Islamic Republic of) All patients with a diagnosis of thrombocytopenia Signing a informed consent form Age over 18 years 18 years no limit Both History of allergy to medicinal plants components Use of nplate drug D69.6 Thrombocytopenia, unspecified Treatment - Drugs Other 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. 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. 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). 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. Shahed University Approved 2020-06-29 Ethics committee of Shahed University Shahed University, In front of the holy of Imam,Persian Gulf Highway, Tehran Tehran Iran (Islamic Republic of)