Determining the effect of bromelain capsule on stress, anxiety, depression in patients with diabetic foot ulcer
Design
Clinical trial with control group, single-blind, randomized with 44 patients in each group
Settings and conduct
Endocrinology and Metabolism Research Center،, Tehran University of Medical Sciences, Tehran, North Iran, Tehran, Iran
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age 18 to 60 years
nformed consent
Mild or moderate score in DASS-21 pre-test
Exclusion criteria:
The patient is taking drugs that interact with bromelain
Patients enrolled in other clinical trial studies
History of other wounds
Intervention groups
Bromelain capsules containing 200 mg of this substance (500 GDU) made by Permon Amin Company will be used orally twice a day (once in the morning before breakfast and once in the evening two hours after dinner) for 4 weeks.
Main outcome variables
Stress, anxiety, depression
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190708044148N2
Registration date:2022-04-26, 1401/02/06
Registration timing:registered_while_recruiting
Last update:2022-04-26, 1401/02/06
Update count:0
Registration date
2022-04-26, 1401/02/06
Registrant information
Name
Alireza Salmani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3283 6289
Email address
alirezasalmani192@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-09, 1401/01/20
Expected recruitment end date
2022-08-23, 1401/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of bromelain capsule on stress, anxiety , depression in patients with diabetic foot ulcer
Public title
The effect of bromelain capsules on stress and depressive anxiety in diabetic foot ulcer patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 to 60 years
Informed consent
Mild or moderate score in DASS-21 pre-test
Exclusion criteria:
The patient is taking drugs that interact with bromelain
Patients enrolled in other clinical trial studies
History of other wounds
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
88
Randomization (investigator's opinion)
Randomized
Randomization description
The samples will be assigned to two groups with a random permutation block design with four blocks. Thus, the letter A is considered for the intervention group and the letter B is considered for the control group. Then we write all the permutation combinations of the letters A and B, which are 6 different combinations, on 6 cards. Thus, BBAA, BABA, BAAB, ABAB, ABBA, AABB, then one of the cards is selected by lottery. This means that the first and second persons are in the control group and the third and fourth persons are in the intervention group, and this will continue until the sample size quorum is reached .In order to prevent and reduce possible bias, the person who will perform a random sequence, check the criteria for entry and exit of participants and assign participants to the intervention and control group, is out of the research team.
Blinding (investigator's opinion)
Single blinded
Blinding description
On the other hand, in order to hide random allocation, it is sealed by non-transparent envelopes.In this way, a number of envelopes are prepared with aluminum wrappers and each of the random sequences created is recorded on a card and the cards are placed in the envelope in order. The sequence is numbered in the same way on the outer surface of the envelopes in order to maintain a random sequence. Finally, the envelopes are sealed and placed in a box. At the beginning of the registration of participants, according to the order of entry of eligible participants to study, one of the envelopes is opened in order and its assigned group The participant will be revealed.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of School of Nursing and Midwifery & Rehabilitation - Tehran University o
Street address
Tehran, Tohid Square, Dr. Mirkhani St. (Eastern Nusrat), School of Nursing and Midwifery
City
Tehran
Province
Tehran
Postal code
1419733171
Approval date
2022-03-13, 1400/12/22
Ethics committee reference number
IR.TUMS.FNM.REC.1400.237
Health conditions studied
1
Description of health condition studied
Diabetic foot ulcer
ICD-10 code
E10.5
ICD-10 code description
Type 1 diabetes mellitus with circulatory complications
Primary outcomes
1
Description
Stress
Timepoint
Measurements before the study and 4 weeks after the start of the intervention
Method of measurement
Depression, Anxiety and Stress Questionnaire (DASS-21)
2
Description
Anxiety
Timepoint
Measurements before the study and 4 weeks after the start of the intervention
Method of measurement
Depression, Anxiety and Stress Questionnaire (DASS-21)
3
Description
Depression
Timepoint
Measurements before the study and 4 weeks after the start of the intervention
Method of measurement
Depression, Anxiety and Stress Questionnaire (DASS-21)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intervention group Bromilin capsules containing 200 mg of this substance (500 GDU) made by Permon Amin Company twice daily (once in the morning before breakfast and once in the evening two hours after dinner) orally for 4 weeks after the start of the intervention they take.
Category
Treatment - Other
2
Description
Control group: The control group will not receive bromelain supplementation and will receive routine treatment
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Endocrinology & Metabolism Research Center
Full name of responsible person
Alireza Salmani
Street address
NO 10, Jalal-AL-Ahmad St., Chmaran HWY., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1411713139
Phone
+98 21 8863 1298
Email
emrc@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Akbar Fotouhi
Street address
Keshavarz Boulevard, corner of Quds Street, Central University Organization, sixth floor, Vice Chancellor for Research and Technology
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3686
Email
afotouhi@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Alireza Salmani
Position
Nursing Graduate Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 507،Imam Khomeini street, , Abyek city, Qazvin province,