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

Effect of Humulus Lupulus on early menopausal symptoms in menopausal and perimenopausal women: A Randomised Controlled Trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT2013010110324N7
Enrollment
120
Registered
2013-04-10
Start date
2013-04-21
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Menopause. Menopausal and female climacteric states, Other specified menopausal and perimenopausal disorders

Interventions

Intervention 1: The intervention group will receive 500 mg Humulus Lupulus tablet daily for 90 days. Glandular powder separated from the strobiles of the Humulus lupulus (hops) plant will be used for
Treatment - Drugs
Placebo
The intervention group will receive 500 mg Humulus Lupulus tablet daily for 90 days. Glandular powder separated from the strobiles of the Humulus lupulus (hops) plant will be used for making tablets
The control group will receive 500 mg placebo tablet daily for 90 days. Placebo tablets contain lactose

Sponsors

Vice chancellor for research, Tabriz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
40 Years to 60 Years

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAghamiri Vida

Faculty of Nursing & Midwifery, Tabriz University of Medical Sciences

aghamiri.vida@gmail.com; vida_bist@yahoo.com+98 87 1222 8597

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026