The efficacy of Jazar capsule, a Persian medicine product, on menopausal symptoms and sexual disorder of menopausal women

The efficacy of Jazar capsule, a persian medicine product, on menopausal symptoms and sexual disorder of menopausal women

Clinical trial with intervention and control (placebo) group, double blind, four-way randomized blocks, with sample size of 90 people in two groups of 45 and 2 month study for each person.

The research placesَ are Ahmadiyeh clinic, Aboozar clinic, Farmanfarmayan clinic and Emam-Khomeini hospital(Gynecology clinic). In the intervention group, 500 mg Jazar capsule and in the control (placebo) group 500 mg of starch powder capsule, both are prescribed 2 capsules every 12 hours for two months. Both are identical in terms of appearance and packaging, only differentiated through the proprietary codes set by the pharmacist on the box of medicine. The patient and the prescribing researcher are not aware of the codes.

Inclusion criteria: Married women that their spouses are present at home at least for half of each month; Age between 45-60; No menstrual periods for at least 12 months and no longer than 5 years; Literate or having a literate person at home; Menopause but not due to illness or uterus and ovaries resection; At least 2 hot flashes per day; FSFI ≤ 26; Willing to attend the project; Normal Pap smear during the last two years. Exclusion criteria: Taking other medications to resolve their menopausal signs; Allergy to the medicines of this research; History of serious physical or mental illness; Hormone intake for the past 6 months; Addiction to cigarettes, drugs or alcohol.

Medicine: Jazar capsule Placebo: starch powder

Menopause quality of life, Female sexual function index

Assignment of patients to study groups is done using Block Randomization method. Samples are divided into intervention and placebo groups based on the random sequence generated by the statistic consultant. A random sequence is generated by random four-way blocks; each block represents four participants. Distribution of placebo and interventions in each block is random but under a condition that there must be two placebos and two interventions in each block. Using this method, the number of samples assigned to each of the groups are equal, so in cases that mid-term analysis is required, the equal number of samples for both groups are available.

Medication and placebo are identical in terms of appearance an packaging, only differentiated through the proprietary codes set by the pharmacist on the box of medicine. The patient and the prescribing researcher are not aware of the code. The outcomes of the study are prepared by the researcher who is unaware of the grouping and is blind to the groups and type of medications.