Evaluation of noscapine on pain relief and symptoms of buerger disease
Design
The study of a single, non-randomized, phase 2, two-way informed clinical trial is performed on 15 patients with Buergers' disease.
Settings and conduct
Buerger's patients referred to the office of Dr Taheri, a specialist in vascular surgery, who receive noscapine 30 mg twice a day for 60 days. The study of a single, non-randomized, phase 2, two-way informed clinical trial is performed on 15 patients with Buergers' disease.
Participants/Inclusion and exclusion criteria
-Inclusion criteria:
Age less than 50 years;
Smoking history;
Upper limb involvement or migratory thrombophlebitis;
Infra-popliteal vascular involvement
-Exclusion criteria:
No burning pain and paresthesia at the time of referral;
Allergy symptoms and drug allergies;
More than 2-fold increase in the upper limit of liver enzymes;
More than 2-fold increase in the upper limit of renal function indices;
lake of consent to continued the intervention
Intervention groups
administration of Noscapin capsules twice a day for 60 days
Main outcome variables
Measurement of VAS of pain criteria before and after the treatment
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180103038199N5
Registration date:2021-05-12, 1400/02/22
Registration timing:prospective
Last update:2021-05-12, 1400/02/22
Update count:0
Registration date
2021-05-12, 1400/02/22
Registrant information
Name
Vahid Reza Askari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3800 2264
Email address
askariv941@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-06-22, 1400/04/01
Expected recruitment end date
2023-03-20, 1401/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effectiveness of noscapine capsules in patients with Buerger's disease
Public title
Study of noscapine in Buerger's disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
less than 50 years old
history of cigarette consumption
Upper limb involvement or migratory thrombophlebitis
Infra-popliteal vascular involvement
Exclusion criteria:
No burning pain and paresthesia at the time of referral
Symptoms of allergies and drug allergies
More than 2-fold increase in upper limit of liver enzymes
More than 2-fold increase in upper limit of renal function parameters
Lack of consent for continued intervention
Age
To 50 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
15
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Deputy of Research and Technology of the University, Qurashi Building, Next to Hoveyzeh Cinema, University Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Approval date
2021-04-24, 1400/02/04
Ethics committee reference number
IR.MUMS.REC.1400.025
Health conditions studied
1
Description of health condition studied
Buerger's disease
ICD-10 code
I73.1
ICD-10 code description
Thromboangiitis obliterans [Buerger's disease]
Primary outcomes
1
Description
Evaluation of pain using Visual Analogue Scale (VAS) scoring method
Timepoint
every week
Method of measurement
questionnaire of Visual Analogue Scale of pain
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: receiving Noscapine 30 mg capsules twice daily for 60 days + Common treatment (including apixaban 5 mg/d and vitamin B1 300 mg/d)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dr. Taheri's office located at 20 Daneshgah Street
Full name of responsible person
Dr Vahid Reza Askari
Street address
Mashhad university of medical science, Azadi square
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3800 2000
Email
askariv@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohsen Tafaghodi
Street address
Deputy of Research and Technology of the University , Qurashi Building, Next to Hoveyzeh Cinema, University Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 2081
Email
ramresearch@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Vahid Reza Askari
Position
Assisstant professor of clinical pharmacology
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of medicine, Paradise of University, Vakil-Abad Blvd., Azadi Sq., Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3800 2264
Fax
Email
askariv@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Vahid Reza Askari
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of Medicine, Azadi sq, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 915 371 9688
Email
askariv@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Vahid Reza Askari
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of Medicine, Azadi sq, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 915 371 9688
Email
askariv@mums.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
Study Protocol
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available