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IRCT20220102053605N1 IRCT 2022-06-05 Shahid Beheshti University of Medical Sciences Effect of the “Compound honey syrup” on spermatogenesis in infertile men Effect of the “Compound honey syrup” on spermatogenesis in infertile men 2022-05-28 anticipated 76 Complete https://irct.ir/trial/63597 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization method are made with Permuted blocks .Equal block size .Two group or block A and B. After entering the study, individuals are placed in one of groups A or B. The medication is coded in exactly the same packages and the delivery assistant is based on the sealed envelope that the medication is given to the participant. And does not know whether it is a medication or a placebo. Sample size of 76 people (38 people in each group), Blinding description: Medication and placebo are made in the company by people who are not involved in the study and will be packaged and coded in the same way. The person doing the coding will not have a role in the study until the end of the intervention. The prescribing physician, assistant, and patient will not be aware of any of the contents of the medications, and the medication code will be written on the patient's paper. (double blind). 3 Male infertility. Intervention 1: Intervention group: In addition to Vit E 100IU /day, in the experimental group, compound honey syrup(consisting of honey, ginger, cinnamon, cardamom, saffron and Alpinia officinarum) is also prescribed. Consumption of compound honey syrup, 0.5 ml/kg at 24 h in divided 3 doses(An average of 40 cc per 80 kg person). Each Dose(about 13 cc) Mixes in 100 cc of boiled and lukewarm three time a day 30 minutes after the meal. The study period is 90 days. In the first visit, the participants will be provided with the method of consumption and the daily use table of the medicine. Any ambiguity or question of the participants will be answered via SMS. They will be visited again and the possibilities will be discussed. Intervention 2: Control group: intervention includes consumption of placebo syrup in 200 ml bottles quiet the same as compound honey syrup and consisting of(water, CMC 0.7, Acesulfame potassium 0.05%, sunset yellow 0.003%, tartrazine0.002%, color additives) In addition to VIt E 100IU /day, in the control group, placebo syrup is also prescribed. Consumption of placebo, 0.5 Ml/kg at 24 h in divided 3 doses. Each Dose Mixes in 100 cc of boiled and lukewarm three time a day 30 minutes after the meal(An average of 40 cc per 80 kg person and each dose about 13 cc). The study period is 90 days. Placebo syrup is made by the pharmaceutical group of NIAK company. In the first visit, the participants will be provided with the method of consumption and daily schedule of drug use. Any ambiguity or question of the participants will be answered via SMS. Once in the middle of the course, the participant are visited and ambiguities about problems or possible complications will be discussed. 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 No more Information
public Farrokh Eftekhar
No.8 Shams Alley, Opposite Tavanir St, Vali Asr St, Tehran
Tehran Iran (Islamic Republic of) 1985717443 +98 21 8877 2521 drfarrokheftekhar@gmail.com Shahid Beheshti University of Medical Sciences scientific Dr Roshanak Mokaberinejad
No.8 Shams Alley, Opposite Tavanir St, Vali Asr St,
Tehran Iran (Islamic Republic of) 1985717443 +98 21 8877 2521 mokaberi@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Infertility or subfertility documented with sperm analysis :1-sperm count between 7 to 12 millions/ml AND OR .2-with any defect in morphology and motility state. Infertility history more than one year. patients are available Men with age between 20 to 50 years old. 20 years 50 years Male Testis Atrophy or other urogenital structural or congenital diseases Infectious diseases-prostate or testis infectious diseases Allergy to medication or placebo components Varicocele Chemotherapy-anti coagulant therapy-Androgen or anti androgen therapy Sever systemic diseases smoking or addiction N46 Male infertility Treatment - Drugs Placebo Intervention group: In addition to Vit E 100IU /day, in the experimental group, compound honey syrup(consisting of honey, ginger, cinnamon, cardamom, saffron and Alpinia officinarum) is also prescribed. Consumption of compound honey syrup, 0.5 ml/kg at 24 h in divided 3 doses(An average of 40 cc per 80 kg person). Each Dose(about 13 cc) Mixes in 100 cc of boiled and lukewarm three time a day 30 minutes after the meal. The study period is 90 days. In the first visit, the participants will be provided with the method of consumption and the daily use table of the medicine. Any ambiguity or question of the participants will be answered via SMS. They will be visited again and the possibilities will be discussed. Control group: intervention includes consumption of placebo syrup in 200 ml bottles quiet the same as compound honey syrup and consisting of(water, CMC 0.7, Acesulfame potassium 0.05%, sunset yellow 0.003%, tartrazine0.002%, color additives) In addition to VIt E 100IU /day, in the control group, placebo syrup is also prescribed. Consumption of placebo, 0.5 Ml/kg at 24 h in divided 3 doses. Each Dose Mixes in 100 cc of boiled and lukewarm three time a day 30 minutes after the meal(An average of 40 cc per 80 kg person and each dose about 13 cc). The study period is 90 days. Placebo syrup is made by the pharmaceutical group of NIAK company. In the first visit, the participants will be provided with the method of consumption and daily schedule of drug use. Any ambiguity or question of the participants will be answered via SMS. Once in the middle of the course, the participant are visited and ambiguities about problems or possible complications will be discussed. Sperm count. Timepoint: Before the intervention and after the intervention( intervention period is 90 days). Method of measurement: Semen Analysis. Sperm motility. Timepoint: Before the intervention and after the intervention( intervention period is 90 days). Method of measurement: Semen Analysis. Sperm morphology. Timepoint: Before the intervention and after the intervention( intervention period is 90 days). Method of measurement: Semen Analysis. Shahid Beheshti University of Medical Sciences Approved 2022-05-16 Ethics committee of Shahid Beheshti University of Medical Sciences 7th Floor, Bldg No.2 SBUMS, Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)