Determining the effect of herbal combination medicine (Tiryaqe wabai) on anxiety, depression and sleep in the elderly
Design
Randomized double-blind clinical trials with control group, phase 3, on 108 patients that will be randomly assigned to the case or control group and will take one capsule of the drug or placebo daily, one hour before dinner, for 30 days.
Settings and conduct
Men and women 60 to 75 years refer to the health center randomly divided into two groups to record patient demographic information, blood pressure and medicines and herbal teas. The Hamilton Anxiety, BDI, and the PSQ Questionnaires will be complete. Measurements will be performed again after the intervention.
Participants/Inclusion and exclusion criteria
Men and women aged 60 to 75 years who referred to the health center of Karaj city who obtained more than a quarter of the score obtained from each of the three questionnaires of depression, sleep and anxiety and a history of sensitivity to each of the components used in They do not have the medicine and enter the study.
Intervention groups
They will be in the case or control group and will take one capsule of medicine or placebo daily one hour before dinner for 30 days.
Main outcome variables
depression and anxiety severity , sleep state
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211017052785N2
Registration date:2022-06-14, 1401/03/24
Registration timing:prospective
Last update:2022-06-14, 1401/03/24
Update count:0
Registration date
2022-06-14, 1401/03/24
Registrant information
Name
Mina Maarefvand
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 26 3464 3705
Email address
m.maarefvand@abzums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-08-06, 1401/05/15
Expected recruitment end date
2023-05-05, 1402/02/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of herbal medicine (Tiryaqe wabai) on anxiety, depression and sleep in the elderly: A double-blind randomized controlled clinical trial
Public title
The effect of herbal medicine (Tiryaqe wabai) on anxiety, depression and sleep in the elderly
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Men and women aged 60 to 75 years referred to the health center of Karaj city
Having the desire and satisfaction to participate in the project
Obtain more than a quarter of the score from each of the three Depression, Sleep, and Anxiety Questionnaires
Exclusion criteria:
Inability to take the drug in capsule form
Do not have a history of allergies to any of the ingredients used in the medicine
Do not change the amount of medication taken for any of the three conditions of anxiety, depression and sleep
Have serious underlying conditions such as uncontrolled blood pressure or diabetes, untreated ischemic heart disease, kidney and liver failure.
Age
From 60 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
108
Randomization (investigator's opinion)
Randomized
Randomization description
Assignment of individuals to the intervention and control groups will be done using block randomization method with the size of 4, 6 and 8 non-identical blocks (to hide the allocation). Statistical or web-based software such as https://www.sealedenvelope.com/simple-randomiser/v1/lists will be used for this purpose. In this method, the order of block size as well as the allocation of people in groups is randomly selected. In such a way that first 4, 6 or 8 blocks are randomly selected and in the selected block, the order of assigning individuals to the intervention and control group is determined randomly. In the study, they will be assigned to the intervention and control groups based on the production chain, respectively.
Blinding (investigator's opinion)
Double blinded
Blinding description
For blinding, medicine and placebo are prepared, packaged and numbered by the pharmacist and the project manager and sampler will not be informed of their contents. Patients are also unaware that the capsule is taking medication or placebo.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Alborz University of Medical Sciences
Street address
45 meters from Golshahr - Saffarian Alley - Deputy of Research and Technology
City
Alborz
Province
Alborz
Postal code
3198764653
Approval date
2022-05-21, 1401/02/31
Ethics committee reference number
IR.ABZUMS.REC.1401.050
Health conditions studied
1
Description of health condition studied
Depression
ICD-10 code
F34
ICD-10 code description
Persistent mood [affective] disorders
2
Description of health condition studied
anxiety disorder
ICD-10 code
F41.1
ICD-10 code description
Generalized anxiety disorder
Primary outcomes
1
Description
anxiety Severity
Timepoint
Beginning and end of the study
Method of measurement
Hamilton Anxiety Questionnaire
2
Description
depression severity
Timepoint
Beginning and end of the study
Method of measurement
Beck Depression Inventory BDI-II
3
Description
Sleep status
Timepoint
Beginning and end of the study
Method of measurement
Petersburg Sleep Quality Questionnaire (PSQI)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intervention group: One capsule of Tiryaqe wabai is taken daily for 30 days one hour before dinner. Raw materials of medicine, prepared from reliable sources. And an initial assessment is made of its quality. Tiryaqe wabai is prepared by mixing Saffron powders, Aloe vera gel and Myhrr and according to the instructions mentioned in the sources of traditional medicine, including the Tohfat al mo'menin, the Exire A'zam, and Tebe Akbari, and is packaged in the form of capsules. Standardization of the drug is done by measuring total phenol, determining the amount of crocin and alloine, as well as microbial control.
Category
Treatment - Drugs
2
Description
Control group: Take one placebo capsule daily for 30 days one hour before dinner. A suitable placebo is prepared with sufficient similarity and is prepared in similar packages of the drug.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Avini Comprehensive Health Center
Full name of responsible person
Mina Maarefvand
Street address
Kianmehr, Amir Kabir Boulevard, Azadi Boulevard
City
Karaj
Province
Alborz
Postal code
2633204636
Phone
+98 26 3320 4636
Email
dr.m.maarefvand@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Dr. Hatem Godini
Street address
45 meters from Golshahr - Saffarian Alley - Deputy of Research and Technology
City
karaj
Province
Alborz
Postal code
3198764653
Phone
+98 26 3464 3774
Email
Research@abzums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Karaj 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
Karaj University of Medical Sciences
Full name of responsible person
Mina Maarefvand
Position
Non-faculty specialist physician
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
45 meters from Golshahr - Saffarian Alley - Deputy of Research and Technology
City
Karaj
Province
Alborz
Postal code
3198764653
Phone
+98 26 3464 3774
Email
dr.m.maarefvand@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Mina Maarefvand
Position
Non-faculty specialist physician
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
45 meters from Golshahr - Saffarian Alley - Deputy of Research and Technology
City
Karaj
Province
Alborz
Postal code
3198764653
Phone
+98 26 3464 3774
Email
dr.m.maarefvand@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Mina Maarefvand
Position
Non-faculty specialist physician
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
45 meters from Golshahr - Saffarian Alley - Deputy of Research and Technology
City
Karaj
Province
Alborz
Postal code
3198764653
Phone
+98 26 3464 3774
Email
dr.m.maarefvand@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
Not applicable
Title and more details about the data/document
Part of the data, such as information about the main consequences, can be shared by inserting it in the study article.
When the data will become available and for how long
Access period starts 8 months after the results are published
To whom data/document is available
Only for researchers working in academic and scientific institutions
Under which criteria data/document could be used
Using data to advance scientific goals
From where data/document is obtainable
Dr. Maarefvand
What processes are involved for a request to access data/document
Send the request for information via the announced gmail and the party will receive a response within a maximum of two weeks. dr.m.maarefvand@gmail.com