According to our previous in vitro and animal model studies, in a one-group before and -after design, we investigated the effect of Tribulus terrestris (TT) aqueous extract on count and function of platelets in immune thrombocytopenic purpura (ITP) patients. The aqueous extract of T.T areal parts was shed dried and formulated in the form of 400 mg capsules. Twenty ITP patients (7 males and 13 females) within the range of 20-40 years old range, recognized as ITP disease, were selected for this study. They had clinical signs of ITP and platelet count of less than 100000 cells/µl. The patients were treated with the dosage of 10 mg/kg, oral consumption, three times a day for 14 consecutive days. The blood samples were taken before treatment and on day 1, 14, and 28 after treatment. Platelets count was measured using a cell counter device. In addition, certain platelet factors level such as platelet factor 4 (PF4), Von Willebrand factor (VWF) and serotonin were determined using the relevant ELISA kits.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015062322884N1
Registration date:2017-06-23, 1396/04/02
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-06-23, 1396/04/02
Registrant information
Name
Ali Mostafaie
Name of organization / entity
Medical Biology Research Center, Kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 3427 9923
Email address
amostafaie@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
A grant from Vice Chancellor for Research and Technology, Kermanshah University of Medical Sciences
Expected recruitment start date
2015-04-10, 1394/01/21
Expected recruitment end date
2015-09-21, 1394/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Tribulus terretris aqueous extract on count and
function of platelet in Immune Thrombocytopenic Purpura patients
Public title
The effect of Tribulus terrestris on Immune Thrombocytopenic Purpura
Purpose
Treatment
Inclusion/Exclusion criteria
Non-medication with any drugs such as corticosteroids
Age
From 74 years old to 54 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
One-group before and after design study
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
Building No 2, Kermanshah University of Medical Sciences, Shahid Beheshti boulevard
City
Kermanshah
Postal code
6714869914
Approval date
2013-02-12, 1391/11/24
Ethics committee reference number
11/91
Health conditions studied
1
Description of health condition studied
Immune Thrombocytopenic Purpura
ICD-10 code
D69.3
ICD-10 code description
Idiopathic thrombocytopenic purpura
Primary outcomes
1
Description
Counts of platelets
Timepoint
Before intervention, one day, two weeks and four weeks after intervention
Method of measurement
Count of platelets and blood cells using cell counter device and report as cells/microliter of blood
2
Description
Platelet factor 4 (PF4) level
Timepoint
Before intervention, one day, two weeks and four weeks after intervention
Method of measurement
Assay of PF4 using ELISA method and report at ng/ml of serum
3
Description
Von Willebrand factor level
Timepoint
Before intervention, one day, two weeks and four weeks after intervention
Method of measurement
Assay using ELISA and report at ng/ml of serum
4
Description
Serotonin level
Timepoint
Before intervention, one day, two weeks and four weeks after intervention
Method of measurement
Assay using ELISA and report at ng/ml of serum
Secondary outcomes
1
Description
Purpura (Skin hemorrhagic spots)
Timepoint
Before intervention, one day, two weeks and four weeks after intervention
Method of measurement
Distribution of spots by visual examination and size of spots by a ruler (mm)
Intervention groups
1
Description
Intervention: Aqueous extract of Tribulus terretris , 400 mg capsules. Dosage: Three capsules a day for 14 days.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ayatollah Taleghani Hospital , Kermanshah University of Medical Sciences