Effect of Humulus Lupulus on early menopausal symptoms in menopausal and perimenopausal wome

Phase 2

• Conditions: Menopause.; Menopausal and female climacteric states, Other specified menopausal and perimenopausal disorders; N95.1, N95

• Registration Number: IRCT2013010110324N7
• Lead Sponsor: Vice chancellor for research, Tabriz University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 February 2018

Recruitment & Eligibility

• Status: Complete
• Sex: Female
• Target Recruitment: 120

Inclusion Criteria

Married women aged 40 to 60 years; Willingness to participate in the study; Complaining of hot flashes; having literacy and being able to answer questions; having a Phone; having a score greater than 15 and less than 42 based on Greene scale.
Exclusion criteria: Taking drugs including sulfonamides, methotrexate, triamterene, sulfasalazine, estrogen, phenytoin, benzodiazepines, antidepressants, antithyroid, chemical drugs and multivitamin; hormone therapy and the use of OCP during the last 3 months, using vegetable alternative supplement for vasomotor symptoms during the past month; Contraindications of hormone therapy including suspected or known breast or endometrial cancer, undiagnosed abnormal vaginal bleeding, active thromboembolic disorders and active disease of liver or gallbladder; sensitive to lactose; use of medicines that cause hot flushes including breast cancer treatment drugs like letrozole, raloxifene, amlodipine, Bethanecol, hydrochloride, desmopressin and calcitonin.

Exclusion Criteria

Not provided

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Total and subdomains scores of early menopause symptoms in perimenopausal women. Timepoint: Before intervention, 4, 8 and 12 weeks after intervention. Method of measurement: Greene scale.;Total and subdomains scores of early menopause symptoms in postmenopausal women. Timepoint: Before intervention, 4, 8 and 12 weeks after intervention. Method of measurement: Greene scale.;Frequency of hot flashes in perimenopausal women. Timepoint: Before interventions, 4, 8 and 12 weeks after intervention. Method of measurement: Checklist for daily counts.;Frequency of hot flashes in postmenopausal women. Timepoint: Before intervention, 4, 8 and 12 weeks after intervention. Method of measurement: Checklist for daily counts.

Secondary Outcome Measures

Name	Time	Method
Comparison of the effect of Humulus Lupulus on early menopause symptoms and frequency of hot flushes in postmenopausal and perimenopausal women. Timepoint: 4, 8 and 12 weeks after intervention. Method of measurement: Greene scale and Checklist for daily counts.