Evaluation of the therapeutic effects of bromelain-based supplement (Anaheal 1200 GDU enteric coated) on ecchymosis, swelling and pain after blepharoplasty in patients over 18 years old versus placebo

Evaluation of the therapeutic effects of bromelain-based supplement (anaheal 1200 GDU enteric coated) on ecchymosis, swelling and pain after blepharoplasty

A randomized double blinded placebo-control phase 3 clinical trial on 50 patients.

This study will be conducted on post-blepharoplasty patients over 18 years of age at Saadat Abad Surgery Center. The first group will receive antibiotics, pain relievers, anti-inflammatory medications, and the Anaheal 1200 GDU supplement, which contains bromelain. The second group will receive antibiotics, pain relievers, anti-inflammatory medications, and a placebo containing Avicel. All patients will be provided with an informed consent form to ensure they are fully informed about the study process.

Inclusion criteria: Adults 18 years and older who have undergone blepharoplasty, are able to complete the consent form, and can follow the study protocol appropriately. Exclusion criteria: patients with allergies to certain foods (pineapple, celery, carrots, fennel), pregnant and lactating women, severe kidney and liver disorders, hemophilia, taking anticoagulants, patients with irregular heartbeat, tachycardia, asthma and other allergies that could interfere with the study.

In the experimental group, 25 adult post blepharoplasty patients will receive the Anaheal 1200 GDU supplement in addition to standard treatment. In the control group, 25 post blepharoplasty adults will receive a placebo in addition to standard treatment.

the rate of ecchymosis, swelling and pain

In this study, volunteers were individually assigned into two Groups (drug and placebo) using block randomization. It should be noted that 4 sized blocks are used in this method. Block randomization was done using the "https://www.sealedenvelope.com/simple-randomiser/v1/lists" website and the obtained specialized codes (including two English letters and one number) were assigned to each candidate in the order of entry.

Block randomization is performed by an independent individual who labels the drugs and placebos based on the generated codes. The physician and the study executor administer the drug/placebo to patients using the corresponding code, without knowing the type of treatment. Similarly, patients receive treatment based on the specified code and are unaware of their treatment type. It is worth mentioning that the statistician is aware of the group allocations and uses the information provided by the independent individual to categorize patients into two groups and perform the statistical tests.

The final results of scoring the condition of the ecchymosis, swelling, pain and related parameters

After publishing the related article in international journals

Researchers in the field of medicine and pharmacy

Development of science and expand evidence related to treatment in further research

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