Health Condition 1: N958- Other specified menopausal and perimenopausal disorders
Conditions
Interventions
Intervention1: ShataVida: Oral administration of one 250 mg tablet for 56 days
Control Intervention1: Placebo: Oral administration of one 250 mg tablet for 56 days
Sponsors
Vidya Herbs Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Subjects with a BMI of 18.5 to 29.9 kg/m2 2.Subjects considered as healthy by Principal Investigator through medical history and laboratory results during screening 3.Subjects with moderate or severe rating according to the modified Kupperman menopausal index severity grading 4. Subjective symptoms of hot flushes 5.Subjects willing and able to give informed consent and comply with the study procedures 6.Subjects who agree to maintain their usual dietary habits and level of exercise i.e. maintain their usual lifestyle throughout the trial period 7.Subjects willing to refrain from taking any medications or preparations for addressing menopause symptoms, stress or anxiety or mood or sleep (herbal, dietary supplements, homeopathic preparations, etc.) during the study 8.Subjects willing to refrain from consuming alcohol 24 hours prior to the test days 9. Subjects willing to refrain from consuming caffeine and caffeine-containing products 12 hour prior to test days 10. Subjects willing to refrain from vigorous physical activity 12 hours prior to test days 11.Subjects willing to provide written consent 12.Subjects willing and able to understand and comply with the requirements of the study, consume the study IP as instructed, return for the required treatment period visits, comply with therapy prohibitions, and be able to complete the study
Exclusion criteria
Exclusion criteria: 1.Subject with a medical history of breast cancer, cervical cancer, endometrial cancer, colorectal cancer, or ovarian cancer 2.Subject with untreated or under medication of thyroid disorders 3.Subject with a history or current diagnosis of any major diseases of cardiovascular, gastrointestinal, hepatic, renal, pulmonary, or endocrine systems 4.Subjects with a psychiatric diagnosis including anxiety or depression 5.Subjects with sleep disturbances and/or are taking sleep aid medication 6.Subjects with history of using hormonal therapy for menopause 7.Subjects with uncontrolled diabetes and hypertension 8.Subject with a history or current diagnosis of autoimmune conditions 9.Subjects with HIV positive status 10. Subject with alcohol intake greater than 2 standard drinks per day or use of recreational drugs (such as cocaine, methamphetamine, marijuana, etc.) and smokers 11.Participation in any other trials involving investigational or marketed products within 30 days prior to the screening visit 12.Clinically significant or abnormal laboratory results during screening 13.Any condition judged by the investigator to be unsuitable for participation in the study 14.Subjects having hypersensitivity or history of allergy to the study product 15.Subjects, who are pregnant, breast feeding or planning to become pregnant during the study period 16.Subjects leading irregular lifestyles 17.Any additional condition(s) that in the Investigators opinion would warrant exclusion from the study or prevent the subject from completing the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change of perimenopausal and menopausal symptoms by various assessmentsTimepoint: Screening, Day 28 and Day 56 | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean change in serum hormone levelsTimepoint: Baseline, Day 56;Overall SafetyTimepoint: Baseline, Day 56 | — |
Countries
India
Contacts
Public ContactJestin V Thomas
Leads Clinical Research and Bio Services Pvt. Ltd
Outcome results
None listed