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Evaluate the effect of Peganum Harmala on glycemic index in diabetic patient, a triple-blind randomized, placebo controlled trial

Protocol summary

Study aim
This study aimed to the Effect of Peganum Harmala patients with type 2 diabetic deals.
Design
A randomised controlled clinical trial and triple blind ,parallel study
Settings and conduct
This study is conducted at Shahid Beheshti Hospital in Qom and is blinded by placebo.
Participants/Inclusion and exclusion criteria
Inclusion criteria:type 2 diabetes over a year;age group40-75;Distal polyneuropathy resolutions based on questionnaires Michigan;HBA1C8% -10% Exclusion criteria:Kidney,liver,and heart failure based on the tests, history and physical exam;High blood pressure more than 180 mm Hg and advanced diabetic Retinopathy;The recent use of drugs for neuropathy {gabapentin , nortriptyline};Fever;Pergnancy and lactation;History of amputation
Intervention groups
patient with type 2 diabetes which is divided into two groups of Peganum Harmala capsule and placebo capsule .placebo similar to the drug.
Main outcome variables
Fasting blood sugar

General information

Reason for update
Acronym
QDS
IRCT registration information
IRCT registration number: IRCT20170112031893N3
Registration date: 2018-11-25, 1397/09/04
Registration timing: prospective

Last update: 2018-11-25, 1397/09/04
Update count: 0
Registration date
2018-11-25, 1397/09/04
Registrant information
Name
Hossein Yusefi
Name of organization / entity
Qom University of medical science
Country
Iran (Islamic Republic of)
Phone
+98 25 3886 0146
Email address
driran1399@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-21, 1397/11/01
Expected recruitment end date
2019-03-21, 1398/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluate the effect of Peganum Harmala on glycemic index in diabetic patient, a triple-blind randomized, placebo controlled trial
Public title
Evaluate the effect of Peganum Harmala on glycemic index in diabetic patient
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
type 2 diabetes over three year age group40-75 Distal polyneuropathy resolutions based on questionnaires Michigan HBA1C8% -10%
Exclusion criteria:
Kidney,liver,and heart failure based on the tests, history and physical exam High blood pressure more than 180 mm Hg and advanced ; diabetic Retinopathy Pergnancy and lactation History of amputation Fever the recent use of drugs for neuropathy {gabapentin , nortriptyline} ‎Consumers of medicines that induce delayed gastric emptying such as: Acarbose, Miglitol, Exenatid, ‎benzodiazepines, calcium channel blockers, narcotics, alpha-2 adrenergic receptor agonists such as ‎clonidine, tricyclic antidepressants, dopamine agonists, cholinergic muscarinic receptor antagonists, ‎Octreotide, phenothiazines, cyclosporine
Age
From 40 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Patients were randomly allocated into two groups using random numbers table developed by Random Allocation Software
Blinding (investigator's opinion)
Triple blinded
Blinding description
In this study, patients, statistical analyst and physicians are not aware of the allocation of drugs and placebo, and someone outside the group is aware of the allocation of treatment
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Qom University of Medical
Street address
Vice chancellor for research of Qom University of Medical Sciences, Safashar road, Qom, Iran
City
QOM
Province
Ghoum
Postal code
87366-37169
Approval date
2018-11-06, 1397/08/15
Ethics committee reference number
IR.MUQ.REC.1397.132

Health conditions studied

1

Description of health condition studied
Type 2 diabetes
ICD-10 code
E11
ICD-10 code description
Non-insulin-dependent diabetes mellitus

Primary outcomes

1

Description
fasting blood sugar
Timepoint
pre and early post-treatment
Method of measurement
Based on Labratory

Secondary outcomes

1

Description
Distal polyneuropathy
Timepoint
Before and 3 months after the intervention
Method of measurement
Michigan Questionnaire A

Intervention groups

1

Description
Intervention group:The group used Peganum Harmala capsules amount 1 gram for 3 months, every day
Category
Treatment - Drugs

2

Description
Control group: The group used placebo capsules amount 1 gram for 3 months, every day
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Behashti Hospital
Full name of responsible person
Mahmud Perham
Street address
Clinical Research Development Center, Shahid Beheshti Hospital, Shahid Beheshti Blvd, Azadegan Sq, Qom, Iran
City
Qom
Province
Ghoum
Postal code
3719964797
Phone
+98 25 3886 0146
Email
Mahmoud51dr@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Hossein Saghafi
Street address
Namber 83, Alley 4, Alley 1.1, Safashahr Street
City
Qom
Province
Ghoum
Postal code
3719964797
Phone
+98 25 3886 0146
Email
driran1399@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Qom 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
Ghoum University of Medical Sciences
Full name of responsible person
Muhammad hossein Yusefi
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Diabetes
Street address
Clinical Research Development Center, Shahid Beheshti Hospital, Shahid Beheshti Blvd, Azadegan Sq, Qom, Iran
City
Qom
Province
Ghoum
Postal code
3719964797
Phone
+98 25 3886 0146
Email
huqom1394@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Muhammad hossein Yusefi
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Diabetes
Street address
Clinical Research Development Center, Shahid Beheshti Hospital, Shahid Beheshti Blvd, Azadegan Sq, Qom, Iran
City
Qom
Province
Ghoum
Postal code
3713649373
Phone
+98 25 3886 0146
Email
driran1390@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Muhammad hossein Yusefi
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Diabetes
Street address
Clinical Research Development Center, Shahid Beheshti Hospital, Shahid Beheshti Blvd, Azadegan Sq, Qom, Iran
City
Qom
Province
Ghoum
Postal code
3719964797
Phone
+98 25 3886 0146
Email
driran1390@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
With attention due to the type of study and publication of the article, there was no need to mention this
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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