None listed
Conditions
Interventions
Intervention1: VITEX
extract: Dose:300mg Dosing frequency: Capsules Duration:One capsule
orally in the morning after
breakfast upto 60 days.
Control Intervention1: Starch: Dose:300mg Dosing frequen
Sponsors
Ingex Botanicals Private Limited
Bio Actives Japan KK
Eligibility
Inclusion criteria
Inclusion criteria: 1.Menopausal transition (if menstruation has not occurred for more than 3 months). 2.Those with FSH (Follicle stimulating hormone) exceeding 30 mIU/mL. 3.Women aged 40 to 65 who are in menopause (more than 1 year after the last menstruation). 4.Those with a KI (Kupperman Index) score of 25 or higher. 5.Those who complain of clinical menopausal symptoms even if their KI score is less than 25.
Exclusion criteria
Exclusion criteria: Drug use 1.Women who have used hormone preparations such as female hormones or similar hormone preparations plant extracts etc within the past 3 months 2 Drug addicts 3 Those who have used thyroid hormone preparations Clonidine anticoagulants or antithrombotic drug Aspirin Warfarin Clopidogrel etc within the past 3 months 4 Those who have taken medicines related to female menopause or health functional foods within the past 1 month 5 Those who are taking or administering osteoporosis treatment drugs such as bisphosphonates Disease status 6 Those with a body mass index(BMI exceeding 30 kg per m 2 7 Those with a history of endometrial hyperplasia uterine cancer endometrial cancer cervical cancer breast cancer breast disease or cancer related to sex hormones 8 Those who have undergone hysterectomy 9 Women who have had severe migraines thromboembolism cerebrovascular disease myocardial infarction unstable angina within the past year or have had coronary angioplasty 10 Women with mental illnesses such as depression or anxiety disorder or who are currently taking antidepressants or other psychotropic drugs 11 Women with undiagnosed abnormal uterine bleeding 1 year after menopause 12 Those with uncontrolled hypertension SBP 140 mmHg or DBP 90 mmHg 13.Those with uncontrolled diabetes HbA1C 7 0 14 Those with thyroid-stimulating hormone TSH levels above those outside the normal range 15 Those with ALT and AST levels 3 times higher than the upper limit of normal 16 Those with eGFR less than 60 mL min1.73m 2 17 Those with endometrial thickness 7 mm
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Endpoints: 1.Changes in MENQOL 2.Changes in MRS score 3.Changes in QOL questionnaireTimepoint: Day 0, Day 30 and Day 60 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Endpoints 1.Changes in Reduction in hot flushes & Night sweats 2.Changes in Pain score (Muscle & Joint) 3.Changes in Anxiety & Stress levels (Cortisol) 4.Changes in Biomarkers (LH, Estradiol & FSH) 5.Changes in Thyroid Profile (T3, T4 & TSH) 6.Changes in RA Factor 7.To assess the safety of the product through safety assessments(Screening Visit and day 60).Timepoint: Day 0, Day 30 and Day 60. | — |
Countries
India
Contacts
Public ContactDr Ashok Godavarthi
Radiant Research Services Pvt Ltd.
Outcome results
None listed