Protocol summary

Study aim
Evaluation of the effect of honey and fenugreek seed product in the recovery and control of clinical symptoms (cough, sputum, shortness of breath) in patients with chronic obstructive pulmonary disease.  Evaluation of the effect of honey and fenugreek seed product on pulmonary function tests (spirometry) in patients with chronic obstructive pulmonary disease.
Design
The clinical trial work has a control group, with parallel, double-blind, randomized groups on 81 patients, and the type of treatment is allocated to patients in a simple random manner with the help of power G software. ,
Settings and conduct
After the homogenization of the groups in terms of intervening factors, the manufactured drugs including: honey syrup and fenugreek seeds, honey syrup and placebo will be coded. One group will receive honey syrup, the next group will receive a combination of fenugreek and honey, and the third group will receive a placebo. For the double-blindness of the study, the doctor, student, and patient will not know about the coding. And the codes are kept with the analyzer and the code given to each patient will be recorded on the patient information registration form
Participants/Inclusion and exclusion criteria
Patients are randomly selected from those who refer to Tabriz University of Medical Sciences (campus clinic) by a lung specialist with a diagnosis of COPD, who have stable conditions and do not have underlying diseases, age range 30 to 60 years.
Intervention groups
Patients will be divided into three groups of 27 people and one group will receive placebo as a control group, the second group will receive honey syrup and the third group will receive a combination of honey and fenugreek products for 4 weeks.
Main outcome variables
Cough confusion Activity shortness of breathg Spirometry

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20221105056400N1
Registration date: 2022-12-04, 1401/09/13
Registration timing: prospective

Last update: 2022-12-04, 1401/09/13
Update count: 0
Registration date
2022-12-04, 1401/09/13
Registrant information
Name
Parisa Ghaffari bavil oliaie
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3386 3896
Email address
parisagaffari@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-12-29, 1401/10/08
Expected recruitment end date
2023-08-30, 1402/06/08
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of the Honey and the Trigonella foenum-graceum L (fenugreek) ‎seeds product effect on chronic obstructive pulmonary Disease: Double – Blinded ‎Trial‏ ‏
Public title
Effect of Honey and Trigonella foenum of copd
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Moderate COPD Deasese diagnosed with Pulmonologist Deasese with stable condition Deasese age 30-60 deasese with self consent
Exclusion criteria:
Deasese with Diabet Melitos Deasese with Alergy Honey and Trigonella foenum Deasese with Pregnancy or Lactation Deasese with sever COPD Deasese with Underlying deasese such as CF.Heart Failre.Pulmonal Amboly.Ressistant HTN Deasese with Pulmonal canser or other cansers
Age
From 30 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
Sample size
Target sample size: 81
More than 1 sample in each individual
Number of samples in each individual: 27
Deasese division to 27 patient
Randomization (investigator's opinion)
Randomized
Randomization description
ُSimple randomizationDue to the double-blindness of the study, the doctor, student, and patient will not know about the coding. And the codes are kept with the analyzer and the code given to each patient will be recorded on the patient information registration for
Blinding (investigator's opinion)
Double blinded
Blinding description
Direction of Double blind study، doctor medical، student and patient dont know of cods.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
IR.ZUMS.REC.1401.220
Street address
Blvd. of Ostad Saboti, Zanjan University of Medical Sciences
City
Zanjan
Province
Zanjan
Postal code
4513956184
Approval date
2022-11-02, 1401/08/11
Ethics committee reference number
1401.220

Health conditions studied

1

Description of health condition studied
Cronic Obstructive Pulmonary Deasese
ICD-10 code
j44.1
ICD-10 code description
j44.1

Primary outcomes

1

Description
Disease score based on reliability of chronic obstructive pulmonary disease(cat)
Timepoint
Clinical examination and reliability of the disease at the beginning of the study (before intervention) 7, 14 and 21 and after consuming fenugreek and honey syrup at the end of the stud
Method of measurement
Reliability questionnaire of chronic obstructive pulmonary disease( cat ) and spirometry

Secondary outcomes

1

Description
The secondary outcome is the improvement of activity dyspnea and energy level and sleep
Timepoint
Before starting the study, on the 7th, 14th, 21st, and then, take fenugreek and honey syrup
Method of measurement
Reliability standard guidelines for chronic obstructive pulmonary diseases (cat)

2

Description
The secondary outcome is the improvement of activity dyspnea and energy level and sleep
Timepoint
Before starting the study, on the 7th, 14th, 21st, and then, take fenugreek and honey syrup
Method of measurement
Reliability standard guidelines for chronic obstructive pulmonary diseases (cat)

Intervention groups

1

Description
Intervention group:: Patients will be divided into three groups of 27 people and one group will receive placebo and the second group will receive honey syrup and the third group will receive a combination of honey and fenugreek products for 4 weeks. Fenugreek syrup products and Honey and honey syrup will be prepared at the Faculty of Pharmacy of Zanjan University of Medical Sciences and after checking and verifying the quality of herbal ingredients and honey and chemical and microbial stability, the products will be prescribed to patients.The product of fenugreek and honey will be standardized by checking the amount of total saponin based on the active substance Diosgenin. Patients are given a daily amount of syrup containing the extract obtained from 5 grams of fenugreek powder in 2 A divided dose will be prescribed. According to previous studies, the amount of honey will be 40 grams of honey per 100 ml in honey and fenugreek syrup, and honey and placebo syrup will be based on 40 grams of sweetener per 100 ml.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Clinic of Tabriz University of Medical Sciences ( Pardis clinic).
Full name of responsible person
Dr Mehdi Nadiri. Pulmonologist
Street address
New Pastor St.,Pardis Building, 2nd floor
City
Tabriz
Province
East Azarbaijan
Postal code
16471-51666
Phone
+98 41 3540 4862
Email
Mehdi.nadiri@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Dr Samad Nadri
Street address
Azadi Blvd., Zanjan University of Medical Sciences Headquarters, 2nd Building, 1st Floor, Research and Technology Deputy
City
Zanjan
Province
Zanjan
Postal code
4515613191
Phone
+98 24 3315 6141
Email
research@zums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Research and Technology of Zanjan University of Medical Sciences (Dr. Samad Nedri)
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
Zanjan University of Medical Sciences
Full name of responsible person
Dr Parisa Jafari
Position
Traditional medicine doctor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Above Valiasr Square, Valiasr Medical Training Center, Traditional Medicine Clinic
City
زنجان
Province
Zanjan
Postal code
45157-77978
Phone
+98 24 3377 0801
Email
Parisa.jafari.1349@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Dِr Parisa JAFARI
Position
Professor Parisa Jafari
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Above Valiasr North Square, Valiasr Hospital
City
Zanjan
Province
Zanjan
Postal code
45157-77978
Phone
+98 24 3377 0801
Email
Parisa.jafari.1349@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Parisa Ghaffari
Position
Associate professor،Dr Parisa Ghaffari
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
5th floor, No. 9, Tala Building, Babaei 1 ave, Parvaz Block
City
Tabriz
Province
East Azarbaijan
Postal code
51677-53695
Phone
+98 41 3386 3896
Email
parisagaffari@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data cannot be shared after de-identifying individuals, but part of the information related to the main outcome can be shared
When the data will become available and for how long
Start accessing results 6 months later
To whom data/document is available
Researchers working in academic and scientific institutions and people in the pharmaceutical industry
Under which criteria data/document could be used
in order to study students and researchers, especially in the field of herbal medicines and traditional pharmaceuticals, under research-oriented conditions and to continue studies in the field of traditional medicine and other valid fields in the field of health and medicine.
From where data/document is obtainable
My email, mobile number
What processes are involved for a request to access data/document
Six months later, the article was published
Comments
Loading...