Evaluation of effect of Ocimum basilicum L. (basil) and Plantago major on increased blood platelet in ITP Patients
Design
This clinical trial was performed on 50 patients, divided into two groups of 25, including a control group and parallel groups. This study is Double-blind and block randomization method is used.
Settings and conduct
The field of work is clinical - internal. This study is performed in the Tohid Hospital in Sanandaj. Patients, physicians, and nurses who evaluate the outcomes will be blind to the groups studied.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Platelet count between 20,000 and 100,000, Do not take painkillers and corticosteroids
Exclusion Criteria: Lupus erythematosus, Antiphospholipid syndrome, CLL, Infectious agents, Recent bone marrow transplantation
Intervention groups
Intervention group: hydroalcoholic extract of Ocimum basilicum L. (basil) and Plantago major, oral capsule, 400 mg, Three times a day for two months
Control group: placebo containing starch, oral capsule, 400 mg, Three times a day for two months
Main outcome variables
Blood platelet count
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190415043279N7
Registration date:2020-09-14, 1399/06/24
Registration timing:registered_while_recruiting
Last update:2020-09-14, 1399/06/24
Update count:0
Registration date
2020-09-14, 1399/06/24
Registrant information
Name
Pezhman Sharifi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 87 3324 9435
Email address
p.sharifi@muk.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-21, 1398/01/01
Expected recruitment end date
2021-03-21, 1400/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of effect of Ocimum basilicum L. (basil) and Plantago major on increased blood platelet in ITP Patients
Public title
Evaluation of effect of Ocimum basilicum L. (basil) and Plantago major on increased blood platelet
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Platelet count between 20,000 and 100,000
Do not take painkillers and corticosteroids
At first, 50 Patients with the desired profile referred to the Tohid Hospital were detached, and by Randomization, Subjects were randomly divided into two treatment and placebo groups using quadatric permutation blocks.
Blinding (investigator's opinion)
Double blinded
Blinding description
The patient and doctor are not aware of the type of drug (placebo and treatment). Afterwards, drug and placebo will be given confidentially by the relevant expert, and all the information will be recorded separately for each patient and analyzed in the end.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kurdistan University of Medical Sciences
Street address
Pasdaran Blvd, Kurdistan University of Medical Sciences
City
Sanandaj
Province
Kurdistan
Postal code
66117713446
Approval date
2019-03-06, 1397/12/15
Ethics committee reference number
IR.MUK.REC.1397/346
Health conditions studied
1
Description of health condition studied
Immune thrombocytopenic purpura
ICD-10 code
D69.3
ICD-10 code description
Immune thrombocytopenic purpura
Primary outcomes
1
Description
Blood platelet count
Timepoint
Before intervention, one month after intervention, two months after intervention
Method of measurement
Complete blood count (CBC) test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Capsule containing hydroalcoholic extract of Ocimum basilicum L. (basil) and Plantago major at dose of 400 mg three times a day for two consecutive months. These oral capsules are prepared by a reputable pharmacist.
Category
Placebo
2
Description
Control group: Placebo in capsules at dose of 400 mg three times a day for two consecutive months. These placebo oral capsules contain starch and are prepared by a reputable pharmacist.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Tohid Hospital
Full name of responsible person
Bayazid Ghaderi
Street address
Tohid Hospital, Geriashan Ave
City
Sanandaj
Province
Kurdistan
Postal code
6616812131
Phone
+98 87 3366 4645
Email
bayazid.g@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Dr. Afshin Maleki
Street address
Vice Chancellor for research of Kurdistan University of Medical Sciences, Pasdaran Blvd, Sanandaj, Iran.
City
Sanandaj
Province
Kurdistan
Postal code
6617713466
Phone
+98 87 3366 4645
Email
maleki43@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sanandaj University of Medical Sciences
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
Sanandaj University of Medical Sciences
Full name of responsible person
Bayazid Ghaderi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Blood and oncology
Street address
Kurdistan University of Medical Sciences, Pasdaran Blvd, Sanandaj, Iran
City
Sanandaj
Province
Kurdistan
Postal code
6617713466
Phone
+98 87 3366 4645
Email
bayazid.g@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Bayazid Ghaderi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Blood and oncology
Street address
Kurdistan University of Medical Sciences, Pasdaran Blvd, Sanandaj, Iran
City
Sanandaj
Province
Kurdistan
Postal code
6617713466
Phone
+98 87 3366 4645
Email
bayazid.g@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Pezhman Sharifi
Position
Lecturer
Latest degree
Master
Other areas of specialty/work
Microbiology
Street address
Research Department, Tohid Hospital, Tohid Blvd
City
Sanandaj
Province
Kurdistan
Postal code
6616813131
Phone
+98 87 3324 9435
Fax
+98 87 3324 9435
Email
p.sharifi@muk.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available