]>
IRCT20190708044148N2 IRCT 2022-04-26 Tehran University of Medical Sciences The effect of bromelain capsules on stress and depressive anxiety in diabetic foot ulcer patients The effect of bromelain capsule on stress, anxiety , depression in patients with diabetic foot ulcer 2022-04-09 anticipated 88 Complete https://irct.ir/trial/62578 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, 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 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. 3 Diabetic foot ulcer. Intervention 1: 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. Intervention 2: Control group: The control group will not receive bromelain supplementation and will receive routine treatment. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information
public Alireza Salmani
No. 507،Imam Khomeini street, , Abyek city, Qazvin province,
Abyek Iran (Islamic Republic of) 3447116749 +98 28 3283 6289 Alirezasalmani192@gmail.com Tehran University of Medical Sciences scientific Alireza Salmani
No. 507،Imam Khomeini street,Abik city، Qazvin province,
Abyek Iran (Islamic Republic of) 3447116749 +98 28 3283 6289 Alirezasalmani192@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Age 18 to 60 years Informed consent Mild or moderate score in DASS-21 pre-test 18 years 60 years Both The patient is taking drugs that interact with bromelain Patients enrolled in other clinical trial studies History of other wounds E10.5 Type 1 diabetes mellitus with circulatory complications Treatment - Other Other 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. Control group: The control group will not receive bromelain supplementation and will receive routine treatment 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). 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). 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). Tehran University of Medical Sciences Approved 2022-03-13 Research Ethics Committees of School of Nursing and Midwifery & Rehabilitation - Tehran University o Tehran, Tohid Square, Dr. Mirkhani St. (Eastern Nusrat), School of Nursing and Midwifery Tehran Tehran Iran (Islamic Republic of)