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IRCT20230805059047N1 IRCT 2023-08-23 Shahid Beheshti University of Medical Sciences Evaluation of the effectiveness of herbal product on sexual dysfunction and testosterone levels of men undergoing methadone maintenance treatment Evaluation of the effectiveness of herbal product on sexual dysfunction and testosterone levels of men undergoing methadone maintenance treatment (MMT) 2023-08-23 anticipated 60 Complete https://irct.ir/trial/71831 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random assignment to intervention and control groups First, using the Random number generation plugin in excel software, a table of random numbers from 1 to 60 is prepared in a non-sequential and scattered manner, and the numbers are assigned to two intervention and control groups of 30 cases. The randomization process is performed by the methodology consultant and clinical researchers are not aware of the randomization process and will only be provided with random codes from 1 to 60, Blinding description: The patient receives the drug (intervention or placebo) in sealed envelopes that are coded. Coding is done by one of the colleagues of the project and the doctor, evaluator and patient are blinded. 2-3 sexual dysfunction. Intervention 1: Intervention group: Dava al-Basal will be prepared in the form of syrup, a combination of onion extract and honey (along with ginger). The method of making medicine (Dava al-Basal): We heat one liter of white onion juice + 50 grams of dry ginger powder + 2 kg of honey until it reaches a consistency (brix above 80). Since the daily consumption of onion in traditional medicine sources is 6.4 grams, the daily consumption of syrup based on the extract obtained from this amount of plant mass is 20 cc, which will be prescribed to the patient in two divided doses (10 cc every 12 hours). The most important components of ginger are its essential oil and resins, and control of the final products is done based on total polyphenol. The drug will be prepared in the pharmaceutical laboratory of the Faculty of Iranian Medicine, Iran University of Medical Sciences. Standardization is based on 20 to 24 mg of total polyphenol (according to gallic acid) is done in every 5 ml of syrup. "Aria Salamat Razi" company, which is approved by the Food and Drug Organization in Iran, will review the microbial tests of herbal product. Intervention 2: Control group: Placebo (Simple syrup) is based on the British Pharmacopoeia with the addition of permitted edible color B1 of Magnolia Company, which will be consumed in the same way as the intervention group. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after de-identifying individuals When: The access period starts 6 months after the results are published To whom: Researchers working in academic and scientific institutions as well as people working in the industry can apply to receive data. Conditions: The data can be used for research purposes. Where to obtain: Dr. Gorban Ali Aghighi should be contacted. Email: aliaghighi48@gmail.com How to obtain: After contact, information is sent within a few days. Comments:
public Ghorbanali Aghighi Alaghejonban
First floor, unit 1, No. 179, Omid doctors building, Serah Afsariyeh, 35 meteri Qasr-e-Firuzeh, second 15 meteri of Islamabad, in front of Chehl Seton Hall, Ghoroghi corner
Tehran Iran (Islamic Republic of) 1786863681 +98 21 3382 7033 Aliaghighi48@gmail.com Shahid Beheshti University of Medical Sciences scientific Roshanak Mokaberinejad
Department of Traditional Medicine, Faculty of Traditional Medicine, Abbaspur Street (Tavanir), not reaching Vali Asr Street, Shams Dead End
Tehran Iran (Islamic Republic of) 1516745811 +98 21 8877 3521 rmokaberi@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Men (who are recovering from drug addiction) with sexual dysfunction confirmed by a specialist Age between 20 and 50 years Not receiving special treatment for sexual dysfunction at least three months before enrolment Being at the beginning of drug addiction treatment by MMT 20 years 50 years Male Sexual dysfunction caused by other problems (than addiction) Using other drugs (started before or during the study) Alcohol addiction Severe liver and kidney problems F11.281 Opioid dependence with opioid-induced sexual dysfunction Treatment - Drugs Placebo Intervention group: Dava al-Basal will be prepared in the form of syrup, a combination of onion extract and honey (along with ginger). The method of making medicine (Dava al-Basal): We heat one liter of white onion juice + 50 grams of dry ginger powder + 2 kg of honey until it reaches a consistency (brix above 80). Since the daily consumption of onion in traditional medicine sources is 6.4 grams, the daily consumption of syrup based on the extract obtained from this amount of plant mass is 20 cc, which will be prescribed to the patient in two divided doses (10 cc every 12 hours). The most important components of ginger are its essential oil and resins, and control of the final products is done based on total polyphenol. The drug will be prepared in the pharmaceutical laboratory of the Faculty of Iranian Medicine, Iran University of Medical Sciences. Standardization is based on 20 to 24 mg of total polyphenol (according to gallic acid) is done in every 5 ml of syrup. "Aria Salamat Razi" company, which is approved by the Food and Drug Organization in Iran, will review the microbial tests of herbal product. Control group: Placebo (Simple syrup) is based on the British Pharmacopoeia with the addition of permitted edible color B1 of Magnolia Company, which will be consumed in the same way as the intervention group. International Index of Erectile Function (IIEF) score. Timepoint: At the beginning of the study (before intervention) and 60 days after the start of taking the herbal combination. Method of measurement: International Index of Erectile Function (IIEF). Serum testosterone levels. Timepoint: At the beginning of the study (before intervention) and 60 days after the start of taking the herbal combination. Method of measurement: Testing blood samples to measure testosterone levels using the ELISA method. Shahid Beheshti University of Medical Sciences Approved 2023-07-02 Research Ethics Committees of Vice-Chancellor in Research Affairs - Shahid Beheshti University of Me Shahid Chamran Highway - Yemen Street - Arabi Street, Shahid Beheshti University of Medical Sciences and Healthcare Services - building number two of the university headquarters - sixth floor Tehran Tehran Iran (Islamic Republic of)