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The effect of Medicago Sativa syrup on the platelet count of patients with ITP (Idiopathic Thrombocytopenic Purpura)

Protocol summary

Summary
The main aim of this study is to evaluate the effect of alfalfa (Medicago Sativa) on platelet counts in patients with idiopathic thrombocytopenic purpura. This study will be done as a randomized, double-blind, placebo-controlled, clinical trials phase 2 and single-center. 40 patients with ITP who would like to participate in the study and have the Inclusion criteria will be enrolled with convenience sampling and randomly will be divided into two groups of intervention and control. The intervention group will be received Medicago Sativa syrup and daily intake of patients is 5 ml every eight hours and the control group will be received placebo syrup 5 ml every eight hours for 15 days. Laboratory blood test for platelet count, CBC and BT will be done before and after the intervention. Inclusion criteria are definitive diagnosis of ITP by hematologist, aged 15-50 years with platelet count between 50,000 to 150,000, lack of spontaneous bleeding, lack of systemic diseases such as lupus erythematosus and other blood diseases. The patients with an active and spontaneous bleeding, thrombocytopenia below 50,000, need for hospitalization and pregnancy are excluded. The study intervention is Medicago Sativa syrup containing 650 mg of extract of alfalfa in each 5 ml and daily intake of patients is 5 ml every eight hours. The control group will be received placebo syrup 5 ml every eight hours. Variables for main outcomes are measurment of platelet count, CBC and BT before and after the intervention.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017010924993N2
Registration date: 2017-02-04, 1395/11/16
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-02-04, 1395/11/16
Registrant information
Name
Hamideh Naghedi Baghdar
Name of organization / entity
Faculty of Iranian Traditional Medicine and Complementary of Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3855 2188
Email address
naghedih911@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research and Technology Mashhad University of Medical Sciences
Expected recruitment start date
2017-02-03, 1395/11/15
Expected recruitment end date
2018-08-06, 1397/05/15
Actual recruitment start date
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Actual recruitment end date
empty
Trial completion date
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Scientific title
The effect of Medicago Sativa syrup on the platelet count of patients with ITP (Idiopathic Thrombocytopenic Purpura)
Public title
The effect of Medicago Sativa syrup on the platelet count of patients with Idiopathic Thrombocytopenic Purpura
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: the definitive diagnosis of ITP resistant to corticosteroids or corticosteroid dependent by an expert hematologist; platelet count between 50,000 to 150,000; aged between 15 and 50 years; lack of spontaneous bleeding; lack of other blood diseases; lack of systemic disease such as lupus erythematosus; lack of pregnancy; desire to attend the project Exclusion criteria: an active and spontaneous bleeding; need to hospitalization; thrombocytopenia below 50,000; infectious disease; pregnancy
Age
From 15 years old to 50 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Mashhad University of Medical Sciences Ethics Committee
Street address
Research and Technology Vice-Chancellory of Mashhad University of Medical Sciences, Building Qureshi, Daneshgah Ave.
City
Mashhad
Postal code
9138813944
Approval date
2016-12-24, 1395/10/04
Ethics committee reference number
IR.MUMS.REC.1395.470

Health conditions studied

1

Description of health condition studied
Idiopathic Thrombocytopenic Purpura
ICD-10 code
D69.3
ICD-10 code description
Idiopathic Thrombocytopenic Purpura

Primary outcomes

1

Description
Platelet count
Timepoint
Baseline, the end of the study
Method of measurement
Laboratory blood test

Secondary outcomes

1

Description
Complete Blood Count
Timepoint
Baseline, the end of the study
Method of measurement
Laboratory blood test

2

Description
Bleeding Time
Timepoint
Baseline, the end of the study
Method of measurement
Laboratory blood test

Intervention groups

1

Description
In the intervention group, Medicago Sativa syrup containing 650 mg of extract of alfalfa in each 5 ml and daily intake of patients is 5 ml every eight hours.
Category
Treatment - Drugs

2

Description
The control group will be received 5 ml placebo syrup is administered every eight hours.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Isar health clinics affiliated to hospital of Imam Reza
Full name of responsible person
Hamideh Naghedi Baghdar
Street address
Isar health clinics, Sarab alley, Imam Khomeini Ave.
City
Mashhad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Research and Technology Vice-Chancellory of Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Research and Technology Vice-Chancellory of Mashhad University of Medical Sciences, Building Qureshi, Daneshgah Ave.
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research and Technology Vice-Chancellory of Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Faculty of Iranian Traditional Medicine of Mashhad University of Medical Sciences
Full name of responsible person
Hamideh Naghedi Baghdar
Position
Postgraduate Iranian Traditional Medicine
Other areas of specialty/work
Street address
Faculty of Iranian Traditional Medicine, Opposite the Mehran sports hall, East Razi Ave.
City
Mashhad
Postal code
Phone
+98 51 3855 2188
Fax
Email
tim@mums.ac.ir; naghedih911@mums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Faculty of Iranian Traditional Medicine of Mashhad University of Medical Sciences
Full name of responsible person
Zohre Feyzabadi
Position
Associate Professor of Iranian Traditional Medicine
Other areas of specialty/work
Street address
Faculty of Iranian Traditional Medicine, Opposite the Mehran sports hall, East Razi Ave.
City
Mashhad
Postal code
Phone
+98 51 3855 2188
Fax
Email
tim@mums.ac.ir; FeyzabadiZ@mums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Faculty of Iranian Traditional Medicine of Mashhad University of Medical Sciences
Full name of responsible person
Zohre Feyzabadi
Position
Associate Professor of Iranian Traditional Medicine
Other areas of specialty/work
Street address
Faculty of Iranian Traditional Medicine, Opposite the Mehran sports hall, East Razi Ave.
City
Mashhdd
Postal code
Phone
00
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
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Study Protocol
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Statistical Analysis Plan
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Informed Consent Form
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Clinical Study Report
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Analytic Code
empty
Data Dictionary
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