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IRCT20140804018677N6 IRCT 2021-02-15 Research and technology deputy, Shahid Beheshti University of Medical Sciences Effects of bromelain and serrapeptase supplementation on surgical and traumatic wound healing and pain reduction Effects of bromelain and serrapeptase supplementation on surgical and traumatic wound healing and pain reduction (a double blind randomized controlled trial) 2021-02-28 anticipated 80 Complete https://irct.ir/trial/54199 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Participants will have equal chance to be assigned to studied groups. We will use random digits table to make random sequence. After determining the first number, we will continue downward and allocate even numbers to cases and odd numbers to placebo. As in small sample sizes, it would be probable that one group be completed earlier, if one group completed earlier, we will allocate the other assigned numbers to other group. A person out of study group will put her figure on one digit of the table with closed eyes and according to assumed agreement will go downward through the table and write the numbers down until completing the sample size in each group. Code "A" will allocated to even numbers and considered as "intervention group" and code "B" will allocated to odd numbers and considered as "placebo group". At the end we will have the sequence of 80 specific numbers and A&B codes. A person out of study team will put the numbers in sealed packets till the time of sampling, Blinding description: It is a double blind study. A third person out of study team have the sequence of codes that provide the team with sealed pockets containing allocation code at the time of sampling. The following groups of people involved in the trial: participants, Research team including principle investigator, data collectors, and outcome assessors will be blind. N/A trauma. Intervention 1: Intervention group: Eating bromelain/serrapeptase capsules (250 mg bromelain and 30 mg serrapeptase per cap) BD (every 12 hours) for 10 days. Capsules are manufactured in "Dayan Teb Eksir" pharmaceutical company. Intervention 2: Control group: Placebo cap. for 10 days BD (every 12 hours) containing maltodextrine. Capsules are manufactured in "Dayan Teb Eksir" pharmaceutical company. Yes - There is a plan to make this available What will be shared: All data would be available to public When: starting 6 months after publication To whom: To all Conditions: No other criteria Where to obtain: Email to soodehrazeghi@gmail.com How to obtain: sending email Comments:
public Soodeh Razeghi Jahromi
No. 46, West Arghavan St., Farahzadi Blv., Shahrak Qods
Tehran Iran (Islamic Republic of) 1981619573 +98 21 2235 7483 soodehrazeghi@gmail.com Shahid Beheshti University of Medical Sciences scientific Soodeh Razghei Jahromi
No. 46, West Arghavan St., Farahzadi Blv., Qods Town
Tehran Iran (Islamic Republic of) 1981619573 +98 21 2235 7483 soodehrazeghi@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Male and non-pregnant female age>18y Up to 1 week post trauma or surgery Wound size between 1-10 cm tend to use this supplement 18 years no limit Both Allergy to bromelain and serrapeptase Collagen Vascular or autoimmune Diseases mild-moderate and severe wound according to American infectious disease society criteria Using steroidal drugs in 2 months prior to study (exp. inhaled steroidal drugs for COPD and asthma and topical steroidal medication Using antibiotics in a week prior to study radiation therapy of wound HBA1c>10 venous insufficiency or osteomyelitis Using immunosuppressant active malignancies Renal disorders ((blood urea nitrogen < 21.4 mmol/l, creatinine < 247.5 umol/l) or liver failure MI in 3 months prior to study Drug or alcohol abuse G89.11 Acute pain due to trauma Treatment - Other Treatment - Other Intervention group: Eating bromelain/serrapeptase capsules (250 mg bromelain and 30 mg serrapeptase per cap) BD (every 12 hours) for 10 days. Capsules are manufactured in "Dayan Teb Eksir" pharmaceutical company Control group: Placebo cap. for 10 days BD (every 12 hours) containing maltodextrine. Capsules are manufactured in "Dayan Teb Eksir" pharmaceutical company Pain of wound (trauma or surgical). Timepoint: Baseline and at the end of the study. Method of measurement: VAS (visual analog scale). Size of wound (trauma or surgical). Timepoint: Baseline and at the end of the study. Method of measurement: Centimeter. Research and technology deputy, Shahid Beheshti University of Medical Sciences Approved 2021-02-08 Ethics committee of research and technology deputy of Shahid beheshti University of medical Sciences No. 7, West Arghavan Ave., Farahzadi Blvd., Qods Town tehran Tehran Iran (Islamic Republic of)