Investigation of the effect of Royal jelly on sexual function in patients undergoing percutaneous coronary intervention: A randomized, double-blind, placebo-controlled trial

Determination of effect of Royal jelly on sexual function in patients undergoing percutaneous coronary intervention

Clinical trial with control group, with parallel groups, double-blind, randomized, phase 2 on 64 patients to allocate consumption to the subjects will use the randomized block method. The website http://www.randomization.com will also be used for randomization.

Sixty-four patients with ischemic heart disease referred to the rehabilitation clinic of Noor Heart Center in Rasht. patients in two groups of 32 will be subjected to intervention with one capsule containing 1000 mg of royal jelly, and the control group will be given a placebo capsule along with a standard diet. The sampling method will be easy.

Inclusion criteria: cardiac patients undergoing angioplasty in the 3rd phase of cardiac rehabilitation, age range 20 to 70 years, sexual function questionnaire score in men less than 26 and in women less than 23. Exclusion criteria: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

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

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.

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.