None listed
Conditions
Interventions
Intervention1: Female Health Support (GP/PROD/2025/005): 1 Tablet twice a day, 30 minutes before meal.
Control Intervention1: Placebo: 1 Tablet twice a day, 30 minutes before meal.
Sponsors
Gplife Healthcare Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Participants meeting all the following criteria will be eligible for the study: 1. Female participants of age between 40-55 years (both inclusive); 2. Must be experiencing at least two symptoms of menopause, such as sleep disturbances, mood changes, fatigue, lack of energy, hot flashes, night sweats, irritability, anxiety. 3. Beck Depression Inventory 2nd Edition score not more than 19 (minimal-mild depression) at screening; 4. Participants in good general health, in the opinion of the investigator, based on medical history, physical examination and clinical examination at screening. 5. Female participants willing to provide informed consent.
Exclusion criteria
Exclusion criteria: Participants meeting any of the following criteria will not be eligible for the study: 1.Current or previous history of any malignancy; 2.Women undergoing hormone replacement therapy; 3.Any clinically significant prior or ongoing history of gynecological disorders, kidney/liver disease, thyroid disorder; 4.Any other history, condition, therapy, or uncontrolled intercurrent illness which could, in the opinion of the investigator, affect compliance with study requirements; 5.History of food or pollen allergy; 6.Clinically relevant drug or alcohol abuse or smoking; 7.Pregnant or nursing; 8.Participant using or had used any herbs, dietary supplements, medicines or hormonal therapy that contained estrogenic compounds; 9.Participation in any other clinical study within the past 3 months or ongoing; 10.Significant mental health issues that could affect study findings, such as anxiety, depression, or other mental health disorders; 11.Any other reason that, in the opinion of the investigator, excludes the subject from eligibility for study participation; 12.Inability to provide reliable data due to Cognitive impairment or language barriers that may prevent accurate reporting of symptoms
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessment of- 1.Change in Menopausal Index of Blatt and Kupperman. 2.Change in sleep quality using PROMIS Sleep Disturbance or Sleep-Related Impairment questionnaire. 3.Change in estradiol level, follicle stimulating hormone (FSH), dehydroepiandrosterone sulfate (DHEAS) level. 4.Change in depression using Beck Depression Inventory 2nd Edition score.Timepoint: Screening, Visit 1, Visit 2, Visit 3 and Visit 4 | — |
Secondary
| Measure | Time frame |
|---|---|
| Assessment of- 1.Change in fatigue using Fatigue severity scale score. 2.Change in mood using Profile of Mood Status- 2 questionnaire score screening 3.Change in Quality of life using World Health Organization Quality of Life (WHOQOL-BREF) questionnaire score. 4.Safety parameters (CBC, LFT, RFT, and Lipid profile). 5.Changes in vital signs throughout the study. 6.Adverse events profile 7.Compliance and tolerability of the investigational product throughout the study. Timepoint: 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