]>
IRCT20160402027170N2 IRCT 2017-12-20 Tehran University of Medical Sciences The efficacy of Flaxseed oil on the vaginal dryness Comparison of the effectiveness of Flaxseed oil vaginal gel with lubricant vaginal gel on the vaginal dryness in postmenopausal women 2018-01-21 anticipated 94 Complete https://irct.ir/trial/22317 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Allocation to treatment groups was conducted by an independent researcher using a random number sequence, generated with a computer-generated randomization scheme, according to a randomized block design. The block size was six. The randomization list was concealed from the primary researcher who enrolled and assessed participants in sequentially numbered, sealed, opaque envelopes. 3 Vaginal dryness in postmenopausal women. Intervention 1: Intervention group: Flaxseed oil vaginal gel with the applicator 3 nights a week for 8 consecutive weeks. Intervention 2: Control group: Lubricant vaginal gel with the applicator 3 nights a week for 8 consecutive weeks. Yes - There is a plan to make this available What will be shared: Information about the main outcome after unidentifiable people can be shared When: Since print results To whom: Researchers working in academic and scientific institutions Conditions: The data can be used by Iranian and non-Iranian researchers in the field of medical sciences in order to perform IPD Meta-analysis and mentioning the name of the corresponding author of the original article in the colleagues of the secondary article. Other analyzes (other statistical models) are not acceptable and researchers are not allowed to use data to write initial studies. Where to obtain: Email the corresponding author of the article Nejatbakhsh@tums.ac.ir How to obtain: The requester sends a letter to the corresponding author of the article and sends a valid certificate of employment in academic and scientific institutions. The author responds within a maximum of 3 weeks and sends the data file Comments:
public Nejatbakhsh Fatemeh
No 27, Corner Alley Tabriz, Sarparast Shomali Str, Taleghani Ave
Tehran Iran (Islamic Republic of) 1416663361 +98 21 8899 0837 Nejatbakhsh@tums.ac.ir Tehran University of Medical Sciences scientific Nejatbakhsh Fatemeh
No 27, Corner Alley Tabriz, Sarparast Shomali Str, Taleghani Ave
Tehran Iran (Islamic Republic of) 1446663361 +98 21 8899 0837 Nejatbakhsh@tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Postmenopausal women aged 65-45 Menopause diagnosis with one of these symptoms: had a history of at least 1 year of amenorrhea or a high level of follicle-stimulating hormone (FSH) above 40 or bilateral oophorectomy 45 years 65 years Female History of oral estrogen consumption in the 8 weeks prior to study Active vaginal infection Systemic disease N95.2 Postmenopausal atrophic vaginitis Treatment - Drugs Treatment - Drugs Intervention group: Flaxseed oil vaginal gel with the applicator 3 nights a week for 8 consecutive weeks Control group: Lubricant vaginal gel with the applicator 3 nights a week for 8 consecutive weeks Score of vaginal dryness in Visual Analoge Scale (VAS). Timepoint: Before the intervention begins, the end of the intervention. Method of measurement: Visual Analoge Scale (VAS). Score of vaginal burning in Visual Analoge Scale (VAS). Timepoint: Before the intervention begins, the end of the intervention. Method of measurement: Visual Analoge Scale (VAS). Score of vaginal itching in Visual Analoge Scale (VAS). Timepoint: Before the intervention begins, the end of the intervention. Method of measurement: Visual Analoge Scale (VAS). Score of dyspareunia in Visual Analoge Scale (VAS). Timepoint: Before the intervention begins, the end of the intervention. Method of measurement: Visual Analoge Scale (VAS). Score of Vaginal Health Index (VHI). Timepoint: Before the intervention begins, the end of the intervention. Method of measurement: Vaginal Health Index (VHI) questionnaire. Percentage of Vaginal Maturation Index (VMI). Timepoint: Before the intervention begins, the end of the intervention. Method of measurement: Vaginal Maturation Index (VMI) questionnaire. Tehran University of Medical Sciences Approved 2016-02-22 Ethics committee of Tehran University of Medical Sciences Central building of Tehran University of Medical Sciences, near Quds St., Keshavarz Ave Tehran Tehran Iran (Islamic Republic of)