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IRCT20180205038626N13 IRCT 2023-11-06 Rasht University of Medical Sciences effect of Royal jelly on sexual function in patients undergoing percutaneous coronary intervention Investigation of the effect of Royal jelly on sexual function in patients undergoing percutaneous coronary intervention: A randomized, double-blind, placebo-controlled trial 2023-11-22 anticipated 64 Complete https://irct.ir/trial/73563 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The method of sampling and randomization of the two-blind, parallel-group clinical trial study will be stratified block randomization. each person was randomly assigned to the intervention or control group using 1: 4 random blocks. Took. In this method, each group will be assigned one of the letters A or B. The website will also be used for randomization. The list of codes obtained from this website will be provided to the researchers, and each referring patient who met the inclusion criteria and did not meet the inclusion criteria and was willing to participate in the study, first entered the desired age group and based on The assigned code A or B enters the design. For concealment, in this study, random allocation concealment, which is the method used to execute a random sequence on the study participants, will be used in such a way that the assigned group is not known before the individual is assigned. In this way, using opaque envelopes sealed with a random sequence, in this method, each of the random sequences created is recorded on a card and the cards are placed inside the envelopes in order. In order to maintain a random sequence, the envelopes are numbered in the same way on the outer surface. Finally, the lids of the letter envelopes are glued and placed inside a box, respectively. At the beginning of the registration of participants, based on the order of entry of eligible participants into the study, one of the envelopes of the letter is opened in order and the assigned group of the participant is revealed, Blinding description: Since the capsules containing royal jelly and placebo have been tried to be completely similar to each other due to the similarity in taste, taste, aroma and smell, the patients receiving and the researchers providing the supplements are of the type of supplement that each participant receives. They will not be aware. 2 Ischaemic heart diseases. Intervention 1: Intervention group: cardiac patients undergoing angioplasty in the 3rd phase of cardiac rehabilitation, one capsule containing 1000 mg of royal jelly will be prescribed daily for 8 weeks. Intervention 2: Control group: cardiac patients undergoing angioplasty in the 3rd phase of cardiac rehabilitation, one capsule daily for 8 weeks The number of placebo capsules is prescribed. 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 There is no further information
public Zahra Ahmadnia
Dr. Heshmat Hospital; Bayani St; Mosala Square; Rasht.
Rasht Iran (Islamic Republic of) 4193955588 +98 13 3366 9064 zahmadnia1365@gmail.com Rasht University of Medical Sciences scientific Zahra Ahmadnia
Dr. Heshmat Hospital; Bayani St; Mosala Square; Rasht.
Rasht Iran (Islamic Republic of) 4193955588 +98 13 3366 9064 zahmadnia1365@gmail.com Rasht University of Medical Sciences Iran (Islamic Republic of) Cardiac patients undergoing angioplasty in phase 3 of cardiac rehabilitation Married Patients with an age range of 20 to 70 years The score of sexual function questionnaire in men is less than 26 and in women less than 23 20 years 70 years Both Symptomatic cardiac patients Candidate for stenting in another vessel History of urological diseases History of Viagra drug use Taking antidepressants Change in the patient's disease treatment plan during the study​ Changing the type of drugs used, effective factors studied Reluctance to continue the study or cause any dissatisfaction regarding the consuming royal jelly or participation in the study Body mass index greater than 35 Taking warfarin 120-125 Ischaemic heart diseases Treatment - Other Treatment - Other Intervention group: cardiac patients undergoing angioplasty in the 3rd phase of cardiac rehabilitation, one capsule containing 1000 mg of royal jelly will be prescribed daily for 8 weeks. Control group: cardiac patients undergoing angioplasty in the 3rd phase of cardiac rehabilitation, one capsule daily for 8 weeks The number of placebo capsules is prescribed. Sexual function. Timepoint: At the beginning of the study and 8 weeks later. Method of measurement: FSFI questionnaire, IIEF questionnaire. Depression. Timepoint: At the beginning of the study and 8 weeks later. Method of measurement: 13-question short form depression questionnaire. Serum lipid profile levels (triglycerides, total cholesterol, LDL-C and HDL-C). Timepoint: At the beginning of the study and 8 weeks later. Method of measurement: BT2000 device. Prothrombin Time. Timepoint: At the beginning of the study and 8 weeks later. Method of measurement: ELISA device. Partial Thromboplastin Time. Timepoint: At the beginning of the study and 8 weeks later. Method of measurement: ELISA device. Mean systolic and diastolic blood pressure. Timepoint: At the beginning of the study and 8 weeks later. Method of measurement: Pressure indicator. Erythrocyte sedimentation rate. Timepoint: At the beginning of the study and 8 weeks later. Method of measurement: ELISA device. C-reactive protein. Timepoint: At the beginning of the study and 8 weeks later. Method of measurement: ELISA device. Rasht University of Medical Sciences Approved 2023-10-18 Ethics committee of Guilan University of Medical Sciences Technology & Research Vice-chancellor of University; Shahid Siadati St; Namjoo St., Rasht Rasht Guilan Iran (Islamic Republic of)