None listed
Conditions
Interventions
Intervention1: Female Health Support: 1 Tablet twice a day, 30 minutes before meal.
Control Intervention1: Placebo: 1 Tablet twice a day, 30minutes before meal.
Sponsors
Dr Chetan H Savaliya
Eligibility
Inclusion criteria
Inclusion criteria: Participants meeting all the following criteria will be eligible for the study: 1. Applicable for Group A and B: a. Female of age within the range of 18 to 30 years b. Female with or without anaemia; c. Female diagnosed having moderate to severe PMS on the premenstrual symptoms screening tool (PSST) scale; d. Female experiencing fatigue indicating an FSS score of more than 32; e. Must have a BMI not less than 19 and not more than 30 kg per meter square; f. State-Trait Anxiety Inventory score not exceeding 18; 2. Applicable for Group C and D: a. Female participants of age between 40 to 55; years (both inclusive); b. Must be experiencing at least three symptoms of menopause, such as sleep disturbances, mood changes, fatigue, lack of energy, hot flashes, night sweats, irritability, anxiety and irregular periods. c. Beck Depression Inventory 2nd Edition score not more than 19 (minimal mild depression) at screening; d. Females in good general health, in the opinion of the investigator, based on medical history, physical examination and clinical examination at screening. 3. Females willing to participate in clinical trials and who have read understood and signed the informed consent form.
Exclusion criteria
Exclusion criteria: Participants meeting any of the following criteria will not be eligible for the study: 1. Women using or had used any herbs, dietary supplements, medicines or hormonal therapy that contained estrogenic compounds; 2. Women with severe anemia (Haemoglobin less than 8.0 g per dL); 3. Participants with known systemic and metabolic diseases in the investigators discretion not proving fit for trial; 4. Medical history including but not limited to the following: cardiovascular disease, cancer, coagulopathies, current anemia, epilepsy, thyroid disease, parathyroid diseases, diabetes, hepatitis, brain injuries or other brain related diseases, depression treated with prescription medications, liver diseases, abnormal lipid metabolism, digestive disorders (Crohns, pancreatitis, ulcerative colitis), multiple sclerosis, muscular dystrophy, asthma or COPD; 5. Known hypersensitivity to investigational products; 6. 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, fibre supplements, glucosamine or chondroitin probiotics, iron supplements, or protein powders; 7. Pregnant or lactating women, as well as women of childbearing potential who are not using contraception or intending to conceive during the study; 8. Any prescribed medication except for oral contraceptives (not acceptable if oral contraceptives are used to disrupt normal or monthly menstrual cycle) includes recent antibiotic and or oral corticosteroid use; 9. Excessive alcohol consumer; 10. Past or active smokers; 11. Donated blood within two months before study entry, and must not donate blood during the study duration; 12. 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; 13. 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 |
|---|---|
| 1. Assessment of Group A and B participants (Premenstrual Symptoms) - a. Changes in PMS symptoms severity by assessing the Daily Record of Severity of Problems (DRSP). b. Changes in severity of menstrual cramps by numerical rating scale. c. Changes in State-Trait Anxiety Inventory score. 2. Assessment of Group C and D participants (Perimenopause Symptoms)- a. Changes in Menopausal Index of Blatt and Kupperman b. Changes in PROMIS Sleep Disturbance or Sleep-Related Impairment c. Changes in estradiol level, follicle stimulating hormone (FSH), dehydroepiandrosterone sulfate (DHEAS) level d. Changes in depression using Beck Depression Inventory 2nd Edition scoreTimepoint: Screening, Visit 1, Visit 2, Visit 3 and Visit 4 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Changes in Fatigue severity scale score 2. Changes Profile of Mood Status- 2 questionnaire score 3. Assessment of changes in World Health Organization Quality of Life (WHOQOL-BREF) questionnaire score 4. Safety parameters (CBC, LFT, RFT, and Lipid profile) 5. Changes in vital signs 6. Adverse events profile 7. Compliance and tolerability of the investigational productTimepoint: Screening, Visit 1, Visit 2, Visit 3 and Visit 4 | — |
Countries
India
Contacts
Public ContactDr Dheeraj H Nagore
Gplife Healthcare Pvt. Ltd.
Outcome results
None listed