Protocol summary

Study aim
Evaluation of the joint effects of Boswellia serrata, Pimpinella anisum, Hyssopus officinalis, Eucalyptus, and Coriander seed for controlling asthma symptoms of patients with asthma
Design
A Phase 1-2 Randomized, Double-Blind, Placebo-Controlled Clinical Trial on 60 participants. Using balanced block randomization, patients will be enrolled in one of the two groups
Settings and conduct
This study will be conducted in medical centers affiliated to Tabriz University of Medical Sciences. People who are at least 18 years old and have been diagnosed with asthma for at least 6 months will be admitted. Patients will be instructed to continue taking the capsule twice a day for up to 3 months. Safety and effectiveness evaluations will be done in the clinic visits at the beginning of the study, the first month and the third month.
Participants/Inclusion and exclusion criteria
Individuals at least 18 years of age with documented asthma within at least six months and without underlying diseases like liver, kidney, cardiovascular, or endocrine diseases will be included.
Intervention groups
One intervention group (use of Boswellia serrata, Pimpinella anisum, Hyssopus officinalis, Eucalyptus, and Coriander seed twice daily) and one placebo group will receive drugs of the same shape, smell and color.
Main outcome variables
Primary outcomes include forced expiratory volume in 1 second and forced expiratory volume in 1 second to forced vital capacity ratio.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220614055167N5
Registration date: 2024-04-08, 1403/01/20
Registration timing: registered_while_recruiting

Last update: 2024-04-08, 1403/01/20
Update count: 0
Registration date
2024-04-08, 1403/01/20
Registrant information
Name
Saeid Safiri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3332 7195
Email address
saeidsafiri@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-22, 1402/03/01
Expected recruitment end date
2024-05-21, 1403/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Joint Effects of Boswellia serrata, Pimpinella anisum, Hyssopus officinalis, Eucalyptus, and Coriander seed for controlling asthma symptoms of patients with asthma: A Phase 1/2 Randomized, Double-Blind, Placebo-Controlled Clinical Trial
Public title
The Joint Effects of Boswellia serrata, Pimpinella anisum, Hyssopus officinalis, Eucalyptus, and Coriander seed for controlling asthma symptoms
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
One unplanned asthma-related visit to the emergency department or clinic in the past 12 months One night hospitalization in the last 12 months Disturbed sleep more than twice in the last month Asthma symptoms ≥8 times in the last month Use of a β2 agonist ≥8 times in the past month Receiving two short courses (3-7 days) of oral corticosteroids in the past 12 months Funcional expiratory volume in the first second <80% predicted and use of inhalational corticosteroids (ICS) for at least 1 month prior to study entry Women of childbearing potential must be sexually inactive or use effective birth control measures, as determined by the researcher, during the study period and have a negative pregnancy test at the beginning of the study
Exclusion criteria:
People with acute illness (such as colds and flu) within two weeks before the screening visit Any history of systemic disease that the researcher believes would prevent the subject from participating in this study, including viral hepatitis, history of chronic obstructive pulmonary disease, emphysema or other chronic respiratory diseases, underlying kidney, liver, thyroid and diabetes and cardiovascular diseases, abnormal liver function (alanine aminotrasferase/aspartate aminotransferase (ALT/AST) and bilirubin more than 1.25 times the upper limit of normal), abnormal bone marrow function (White blood cells less than 4000/mm3, platelets less than 100,000/mm3 and hemoglobin less than 11 g/dL), abnormal kidney function (blood urea nitrogen (BUN) and creatinine more than 1.25 times the upper limit of normal), abnormal electrocardiogram, forced expiratory volume in 1 second (FEV1) <50% predicted Participation in another experimental treatment study within 30 days prior to this study History of alcohol or drug use Pregnant or lactating women Subjects treated with Omalizumab or immunotherapy for asthma Use of other herbal compounds for the treatment of asthma in the last month before entering the study History of allergy to one of the components of Boswellia serrata, Pimpinella anisum, Hyssopus officinalis, Eucalyptus, or Coriander seed
Age
From 18 years old
Gender
Both
Phase
1-2
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Using block randomization, patients will be assigned to intervention groups or placebo groups. The randomization sequence will be determined by one of the individuals who did not participate in the current research. It is necessary to explain that the aforementioned randomization method reduces the possibility of predicting and manipulating the randomization process by people to zero and will lead to the balance of the size of the groups during and at the end of the study.
Blinding (investigator's opinion)
Double blinded
Blinding description
The patients will receive the boxes sealed with 10-digit codes and will receive the original drug or placebo, and they will not be aware of the type of received material. The researcher will ensure the blinding of the patients. Also, doctors, researchers, and those responsible for the implementation of the project will not be aware of the type of medicine received by the patients until the end of the study.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences, Azadi St, Golgasht Ave.
City
Tabriz
Province
East Azarbaijan
Postal code
5166/15731
Approval date
2023-12-18, 1402/09/27
Ethics committee reference number
IR.TBZMED.REC.1402.725

Health conditions studied

1

Description of health condition studied
Asthma
ICD-10 code
J45
ICD-10 code description
Asthma

Primary outcomes

1

Description
Forced expiratory volume in 1 second
Timepoint
Days 30 and 90
Method of measurement
Spirometry

2

Description
Forced expiratory volume in 1 second to Forced vital capacity ratio
Timepoint
Days 30 and 90
Method of measurement
Spirometry

Secondary outcomes

1

Description
Symptoms of asthma
Timepoint
Days 30 and 90
Method of measurement
Asthma Control Test questionnaire

2

Description
Assessment of quality of life
Timepoint
Days 30 and 90
Method of measurement
Asthma quality of life questionnaire

3

Description
Assessment of sleep quality
Timepoint
Days 30 and 90
Method of measurement
Pittsburgh Sleep Quality Index

4

Description
Adverse events
Timepoint
Days 30 and 90
Method of measurement
Questionnaire

Intervention groups

1

Description
Intervention group: Capsules containing Boswellia serrata, Pimpinella anisum, Hyssopus officinalis, Eucalyptus, and Coriander seed. The plants needed for the research capsule will be purchased from the company and after obtaining the herbarium code from Tabriz Faculty of Pharmacy, they will be extracted by maceration method with water solvent. Then the extract of each plant is dried by lyophilization method and used as dry powder and mixed with maltodextrin in the formulation of edible capsules. In the above formulation, maltodextrin is used as a diluent. Each of the active capsules will contain 250 mg of active ingredients in the form of a combination of dry plant extracts with an equal share and 250 grams of diluent.
Category
Treatment - Drugs

2

Description
Control group: Placebo capsules containing maltodextrin. Participants were administered 2 active or placebo tablets orally twice daily (with lunch and dinner) for 6 months. The capsules will be in 3-month packs (180 units) and one pack will be prescribed to participants at the beginning of the study and one pack during the 3-month visit. Then, identical drug and placebo packages are coded by the pharmacist consultant without the knowledge of the researcher. To improve treatment adherence, participants will be encouraged to adhere to the prescribed regimen and this adherence will be assessed by counting the number of unused capsules at months 3 and 6.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Tabriz University of Medical Sciences
Full name of responsible person
Saeid Safiri
Street address
Golgasht St.
City
Tabriz
Province
East Azarbaijan
Postal code
5166/15731
Phone
+98 51 5566 8474
Email
saeidsafiri@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Research Deputy Tabriz University of Medical Sciences- Saeid Safiri
Street address
Golgasht St.
City
Tabriz
Province
East Azarbaijan
Postal code
5155668474
Phone
+98 41 3335 5948
Email
info@tbzmed.ac.ir
Web page address
https://www.tbzmed.ac.ir/
Grant name
Tabriz University of Medical Sciences
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Saeid Safiri
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
Azadi St., Golgasht Ave., Tabriz University of Medical Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5165665931
Phone
+98 41 3332 7195
Fax
Email
saeidsafiri@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Saeid Safiri
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
Azadi St., Golgasht Ave., Tabriz University of Medical Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5165665931
Phone
+98 41 3332 7195
Fax
Email
saeidsafiri@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Saeid Safiri
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
Azadi St., Golgasht Ave., Tabriz University of Medical Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5165665931
Phone
+98 41 3332 7195
Fax
Email
saeidsafiri@gmail.com

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
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
All of the information will be available to all after publishing without the personal information of participants.
When the data will become available and for how long
After publishing the papers
To whom data/document is available
All researchers that are confirmed by the principal investigator
Under which criteria data/document could be used
All of the data will be available except the personal information of the participants
From where data/document is obtainable
Applicants can initially communicate with the principal investigator's email that is available in this protocol, and if there is no response within a week, a reminder email will be sent again. If they still do not receive an answer, they can call the relevant contact number or send a letter to the listed postal address.
What processes are involved for a request to access data/document
It is evaluated by the team and the principal investigator will inform those who requested
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