Health Condition 1: N959- Unspecified menopausal and perimenopausal disorder
Conditions
Interventions
Intervention1: Almaragus 100mg: Shatavari extract 100mg in 250mg veg capsule once daily for 90 days.
Intervention2: Almaragus 200mg: Shatavari extract 200mg in 250mg veg capsule once daily for 90 days
Sponsors
Arjuna Natural Pvt. Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Cessation of menstruation for greater than 1 year or peri menopausal where no menstrual period for greater than 3 months with a biochemical indicator FSH greater than 20. Menopausal rating scale greater than or equal to 15. An average hot flashes 4-5 over 24 hrs No clinically diagnosed chronic diseases.
Exclusion criteria
Exclusion criteria: Use of hormone replacement therapy in last 3 months before screening date. Estrogen conditions or disorders that significantly alter estrogen physiology (eg:- breast cancer, endometriosis, uterine cancer, uterine fibroids etc.). Clinically diagnosed conditions (hypertension, diabetes, cardiovascular disease, metabolic disorders). Diagnosis of medical or psychiatric conditions including but not limited to: psychiatric disorder (other than mild-to-moderate depression or anxiety), neurological disease (Parkinson s, Alzheimer s disease, intracranial haemorrhage, head or brain injury), cancer/malignancy. Pregnant women or lactating women or history of hysterectomy. Intake of health functional foods related to menopause. Major surgery or hospitalization in the past six months. Participation in another clinical trial within three months. Any condition that may interfere with study compliance or data interpretation. No uncontrolled or clinically significant medical conditions that, in the opinion of the investigator, may interfere with study participation, participant safety, or interpretation of study results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in Menopause Rating Scale (MRS) total score between the Almaragus and placebo groups.Timepoint: Screening/Baseline, Day 30, Day 90. | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean change from baseline in hot flash frequencyTimepoint: Screening/Baseline, Day 30, Day 90.;Mean change in PSQI, PSS,GAD-7,FSSTimepoint: Screening/Baseline, Day 30, Day 90.;Mean change in MENQOLTimepoint: Screening/Baseline, Day 30, Day 90.;Mean change in FSH,Estradiol (E2), LH, and cortisolTimepoint: Screening/Baseline, Day 30, Day 90.;Overall participant satisfaction and tolerability.Timepoint: Day90. | — |
Countries
India
Contacts
Public ContactDr Binu TKuruvilla
Arjuna Natural Pvt Ltd
Outcome results
None listed