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IRCT20150424021917N7 IRCT 2018-02-10 Tabriz University of Medical Sciences Comparison of fenufreek extract vaginal cream with ultra low dose conjugated estrogen vaginal cream on atrophic vaginitis. Comparison of fenufreek extract vaginal cream with ultra low dose conjugated estrogen vaginal cream on atrophic vaginitis among menopausal women. 2018-02-20 anticipated 60 Complete https://irct.ir/trial/28915 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this research randomization will be done using random blocks size 4 and 6. Randomization will be individual randomization. The tool of randomization is random allocation software (RAS). For randome allocation, frenugreek extract vaginal cream and conjugated estrogen cream are put in opaque envelopes. On the envelopes A and B code and numbers are written. Envelops will be given to the participants respectively, Blinding description: In this study, participants, researcher and data analyzer will be blind. Each type of drugs will be the same according to smell, shape and color. the drugs will be accepted code A or B. This code is clarified only of drug formulation specialist. So the participants, researcher and data analyzer will be blind. After data analyzing formulation specialist will be clarified that each code of A and B belong to which group. 3 Atrophic Vaginitis. Intervention 1: Intervention group: ،They will received vaginal cream of fenugreek extract 5%, 0.5 gram or half of applicator twice per week for 12 weeks. Intervention 2: Control group: They will received vaginal cream of conjugated estrogen 0.625mg, 0.5 gram or half of applicator twice per week for 12 weeks. Yes - There is a plan to make this available What will be shared: Primary and secondary outcomes, as well as side events will be distributed. When: Six months after publication of results. To whom: Records will be distributed of academic researchers and " research and development" units of pharmaceutical companies Conditions: " Research and development" unit of each pharmaceutical companies can use of records. All requests will be evaluated after receiving formal e- mail and telephone or face to face negotiation. Where to obtain: Response person is: Dr. Sevil Hakimi Address: Iran, Tabriz, Shariati street, school of nursing and midwifery How to obtain: After 6 months of results publication a request via email is enough for taking records. ! week after receiving request, records are ready for distribution. Comments: There is no extra explanation.
public Sevil Hakimi
School of nursing and midwifery, Shariati street
Tabriz Iran (Islamic Republic of) 5138947977 +98 41347797777 hakimis@tbzmed.ac.ir Tabriz University of Medical Sciences scientific َSevil Hakimi
School of nursing and midwifery, Shariati street,
Tabriz Iran (Islamic Republic of) 5138947977 +98 41 3479 7777 hakimis@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) Menopausal women Physiologic menopasue Having sexual avtivity َAffected by atrophic vaginitis 45 years 55 years Female Vaginal bleeding Hormone replacement therapy during last 3 months History of breast cancer or ant type of estrogen dependent cancer History of breast cancer in first grade relatives (ex. mother, sister) Estrogen contraindication including history of vein thrombosis, any type of vascular disease, thrombophlebitis, N95.2 Senile (atrophic) vaginitis Treatment - Drugs Treatment - Drugs Intervention group: ،They will received vaginal cream of fenugreek extract 5%, 0.5 gram or half of applicator twice per week for 12 weeks. Control group: They will received vaginal cream of conjugated estrogen 0.625mg, 0.5 gram or half of applicator twice per week for 12 weeks. Vaginal symptoms score. Timepoint: Vaginal symptoms score will be measured before and 12 weeks after start id intervention. Method of measurement: For evaluation of this variable we will use of standard questionnare. Vaginal maturation index is the second main outcome. Timepoint: Vaginal maturation index will be measured before and 12 weeks after start id intervention. Method of measurement: This index is indicated to proportion of parabasal, intermediate and superficial cellules . We will taken pap smear from participants. Percent of superficial cellules will be multiply in 1, percent of intermediate cellules will be multiply in 0.5 and percent of parabasal cellules will be multiply in 0. After that all of numbers will be summed. Vaginal pH. Timepoint: Before and 12 weeks after intervention. Method of measurement: Vaginal pH will be measured with using of pH meter kits. Satisfaction from treatment. Timepoint: 12 weeks after start of intervention. Method of measurement: With using of questionnare. Tabriz University of Medical Sciences Approved 2018-01-01 Ethics committee of Tabriz University of Medical Sciences Daneshgah Street, Tabriz University of Medical Science Tabriz East Azarbaijan Iran (Islamic Republic of)