]>
IRCT20230629058615N5 IRCT 2024-09-15 Islamic Azad University Evaluation of the therapeutic effects of bromelain-based supplement (Anaheal 1200 GDU enteric coated) after blepharoplasty 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 2024-10-22 anticipated 50 Complete https://irct.ir/trial/78020 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: 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, Blinding description: 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. 3 Ptosis of eyelid. Intervention 1: Intervention group: includes 25 patients over 18 years old after blepharoplasty. After checking the inclusion and exclusion criteria of the study and obtaining informed consent, patients will receive one Anaheal 1200 GDU enteric coated capsule (manufactured by Salamat Parmoon Amin Company) per day in addition to the standard treatment including painkillers, anti-inflammatories and antibiotics. Patients are examined on days 1, 3, 7 and 14 to evaluate changes in ecchymosis, swelling and pain. Intervention 2: Control group: includes 25 patients over 18 years old after blepharoplasty. After checking the inclusion and exclusion criteria of the study and obtaining informed consent, patients will receive a placebo containing Avicel and having the same appearance as the original medication in addition to the standard treatment including painkillers, anti-inflammatories and antibiotics. Patients are examined on days 1, 3, 7 and 14 to evaluate changes in bruising, swelling and pain. Yes - There is a plan to make this available What will be shared: The final results of scoring the condition of the ecchymosis, swelling, pain and related parameters When: After publishing the related article in international journals To whom: Researchers in the field of medicine and pharmacy Conditions: Development of science and expand evidence related to treatment in further research Where to obtain: Islamic Azad University, Tehran Medical Sciences Branch: Respected applicants can use the following method to receive their desired documents or data from Islamic Azad University, Tehran Medical Sciences Branch: Communication with the Research and Technology Unit: To receive information and documents related to research and clinical trials, applicants can refer to the Research and Technology Unit of the university. Postal Address: Administrative Building Address: Administrative Building of Tehran Islamic Azad University of Medical Sciences, Gol Yakh Street, Ayeneh Boulevard, Amir Pabarja Street, Qolhak , Dr. Shariati Street, Tehran, Iran. Contact Number: 26602642-3 Email: rezazadeh.am@iums.ac.ir Website: www.tms.iau.ir How to obtain: Request Submission and Documentation/Data Retrieval Process from the Research and Technology Department: Request Submission: Applicants must submit their request in writing, including full details (type of documents or data, purpose of request, and related supplementary information) to the university's Research and Technology Department. Method of Submission: Requests can be delivered in person to the Research and Technology Department. Postal Address: Administrative Building Address: Administrative Building of Tehran Islamic Azad University of Medical Sciences, Gol Yakh Street, Ayeneh Boulevard, Amir Pabarja Street, Qolhak , Dr. Shariati Street, Tehran, Iran. Phone Number: 26602642-3.Request Review: After receiving the request, the Research and Technology Department staff will review it. This review includes assessing the content of the request and determining if additional information is needed. If further clarification or adjustments are required, the applicant will be contacted via email or phone. Document/Data Delivery: Once prepared, the requested documents or data will be delivered to the applicant either in person or electronically. Delivery Methods: Electronic: Sent via email. Final Delivery Timeframe: 1 to 2 business days after preparation.Follow-up and Communication: Applicants can contact the Research and Technology Department at any stage of the process to follow up on the status of their request. Phone Number: 26602642-3.stimated Overall Timeframe for Receiving Documents/Data: From the time the request is submitted until the final receipt of documents or data, the process typically takes between 15 and 20 business days." Comments:
public Dorsa sadat Miri
No. 99, yasaman St., Yakhchal St, Shariati Ave.
Tehran Iran (Islamic Republic of) 1941933111 +98 21 2264 0051 dorsamiri792000@gmail.com Islamic Azad University scientific Amir Rezazadeh
School of Pharmacy, Shahid basarati St, shahid kabiri tameh (Shahin Shomali) St ,Hemmat Highway
Tehran Iran (Islamic Republic of) 1475886671 +98 912 729 8761 rezazadeh.am@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Post blepharoplasty surgery patients Age above 18 years Ability to fill out an informed consent form Ability to follow the approved protocol to participate in the study 18 years no limit Both Allergy to pineapple, celery, carrot and fennel Pregnant and breastfeeding women Severe kidney failure (GFR<30) Severe liver failure (Child pugh B, C) Haemophilia Use of anticoagulant, antiplatelet and thrombolytic drugs Patients with irregular heartbeat and tachycardia Asthma patients H02.40 Unspecified ptosis of eyelid Treatment - Drugs Placebo Intervention group: includes 25 patients over 18 years old after blepharoplasty. After checking the inclusion and exclusion criteria of the study and obtaining informed consent, patients will receive one Anaheal 1200 GDU enteric coated capsule (manufactured by Salamat Parmoon Amin Company) per day in addition to the standard treatment including painkillers, anti-inflammatories and antibiotics. Patients are examined on days 1, 3, 7 and 14 to evaluate changes in ecchymosis, swelling and pain. Control group: includes 25 patients over 18 years old after blepharoplasty. After checking the inclusion and exclusion criteria of the study and obtaining informed consent, patients will receive a placebo containing Avicel and having the same appearance as the original medication in addition to the standard treatment including painkillers, anti-inflammatories and antibiotics. Patients are examined on days 1, 3, 7 and 14 to evaluate changes in bruising, swelling and pain. The amount of ecchymosis after blepharoplasty. Timepoint: At 1, 3, 7 and 14 days after surgery. Method of measurement: Based on the questionnaire, the evaluation of the amount of periorbital ecchymosis and the scoring is based on the extent and severity of ecchymosis from 0 to 5. The amount of swelling after blepharoplasty. Timepoint: At 1, 3, 7 and 14 days after surgery. Method of measurement: Based on the questionnaire, the evaluation of the amount of periorbital swelling and The scoring is based on the severity of swelling from 0 to 4. Side effects of Anaheal 1200 GDU. Timepoint: At 1 and 14 days after surgery. Method of measurement: Ask the patient. The amount of pain after blepharoplasty. Timepoint: At 1, 3, 7 and 14 days after surgery. Method of measurement: Visual Analogue Scale. Salamat Parmoon Amin Pharmaceutical company Approved 2024-06-18 The Research Ethics Committees of Pharmacy and Pharmaceutical Sciences - Islamic Azad University No. 99, yasaman St., Yakhchal St, Shariati Ave. Tehran Tehran Iran (Islamic Republic of)