Health Condition 1: N958- Other specified menopausal and perimenopausal disorders
Conditions
Interventions
Intervention1: Multivitamin for Women 40+ Supplement: Multivitamin for Women 40+ Supplement will be administered orally at a dose of 2 capsules once daily for 90 days.
Control Intervention1: Placebo:
Sponsors
Kenzen Ventures Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Women of age within the range of 45 to 60 years 2. Must be experiencing at least two of the following symptoms, such as hot flashes or sweating, heart discomfort, sleep problems, joint or muscular discomfort, depressed mood, irritability, anxiety, physical and mental exhaustion, sexual problems, bladder problems, and dryness of vagina based on MRS 3. Perimenopausal women must meet at least one of the following criteria that A history of amenorrhea for the last 3 11 months from the consent day. Irregular menstrual cycles in the past 12 months from the consent day. 4. Postmenopausal women must be with history of spontaneous amenorrhea for the last12 months 5. Participants in good general health, in the opinion of the investigator, based on medical history, physical examination and clinical examination at screening 6. Participants with controlled diabetes mellitus or controlled hypertension may be included, provided the condition is stable and deemed suitable by the Investigator. 7. Women with a history of hysterectomy may be included, provided they meet all other eligibility criteria and are clinically appropriate for the study. 8. Participants/guardians willing to participate in clinical trials and who have read understood and signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Womens receiving hormonal replacement therapy. 2. Women were excluded if they had gynecological disorders 3. Medical history including but not limited to the following cardiovascular disease, cancer, coagulopathies, current anaemia, epilepsy, thyroid disease, parathyroid diseases, uncontrolled diabetes mellitus, uncontrolled hypertension, hepatitis, brain injuries or other brain-related diseases, depression treated with prescription medications, liver diseases, abnormal lipid metabolism, digestive disorders (Crohn s, pancreatitis, ulcerative colitis), multiple sclerosis, muscular dystrophy, asthma or COPD 4. Known hypersensitivity to ingredients of the investigational products 5. Participants currently taking any of the following supplements for health maintenance or benefits: multivitamin-mineral (MVM), B vitamins, fish oil, Ayurvedic or herbal supplements, nutraceutical supplements, fiber supplements, glucosamine/chondroitin probiotics, iron supplements 6. Past or active smokers 7. Consumers of alcohol, and gt, 5 drinks of alcohol per week (one drink of alcohol was considered to be 142 mL of standard wine, 340 mL of beer, 35 mL of 80-proof liquor, or 10 mL of pure alcohol) 8. Serious illness or any other condition that, in the opinion of the investigator, may compromise the safety or compliance of the patient or preclude the successful completion of the study 9. Participants with hypocalcemia at screening. 10. Have participated in any investigational therapeutic trial within the past 1 year that the investigator feels would influence or affect the outcome of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| a) Assessment of change in menopause symptoms by menopause rating scale (MRS) quality of life questionnaire on screening, day 30, day 60 and day 90.(The MRS is an internationally recognized and validated 5-point Likert scale for the quantitative determination of the severity of physical and psychological menopausal symptoms. It consists of 11 items, including hot flashes/sweating, heart discomfort, sleep problems, joint or muscular discomfort, depressed mood, irritability, anxiety, physical and mental exhaustion, sexual problems, bladder problems, and dryness of vagina). [Time Frame: Baseline, Day 30 2 days, Day 60 2 days and Day 90 2 days] b) Assessment of changes in Calcium, FSH levels assessed at baseline & end of the study. [Time Frame: Baseline and Day 90 2 days]Timepoint: Baseline,Day 30, Day 60 and Day 90 | — |
Secondary
| Measure | Time frame |
|---|---|
| a) Assessment of change in SF-12 (Quality of Life) questionnaire on screening, day 30, day 60 and day 90. b) Assessment of adverse events profile (Severity and Frequency) will be done at baseline, day 30, day 60 and day 90. c) Assessment of treatment compliance and tolerability will be done at day 30, day 60 and day 90. d) Evaluation of changes in overall participant satisfaction with the investigational product, measured using a 5-point Likert scale, to be assessed at baseline and end of the study. e) Assessment of changes in Liver & Kidney (SGOT, SGPT, Urea and Creatinine) parameters w.r.t safety assessed at baseline & end of the study.Timepoint: Baseline,Day 30, Day 60 and Day 90 | — |
Countries
India
Contacts
Public ContactYogendra Kumar Choudhary
Sapthagiri Institute of Medical Sciences and Research Centre
Outcome results
None listed