Health Condition 1: N951- Menopausal and female climactericstates
Conditions
Interventions
Intervention1: Shatavari root extract capsules: One Shatavari root extract capsule daily over 56 days of dosing period.
Control Intervention1: Placebo Capsules: One Placebo capsule daily over 56 days
Sponsors
India Glycols Limited
InVitro Research Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Sexually active females of age between 45 and 55 years (both inclusive). 2. Participants with menopause symptoms, defined as a score of greater or equal to 9 to lesser than equal to 16 in the Menopausal Rating Scale (MRS) at screening (includes both peri-menopausal and post-menopausal women). 3. Perimenopausal and postmenopausal women who are experiencing bothersome VMS (Vasomotor Symptoms). Perimenopause is defined as amenorrhea for greater than 60 days in the past 12 months; post menopause is defined as being without a menstrual cycle due to spontaneous reasons for the preceding 12 months. 4. Female participants who are having more than 10 Hot Flushes events per week for past 5 weeks. 5. Participants who experience at least two symptoms of menopause, such as sleep disturbances, mood changes, fatigue and lack of energy, changes in sexual function, urinary changes, weight gain, or vaginal changes. 6. Participants with BMI between 18 and 40 kg/m2 (both inclusive) at the time of screening. 7. Participants who agree to maintain their usual dietary habits and level of exercise i.e. maintain their usual lifestyle throughout the trial period. 8. Participants 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. 9. Participants who do not have any substance dependence or withdrawal (tobacco, alcohol, medications etc.,). 10. Participants willing to refrain from consuming caffeine and caffeine-containing products 12 hours prior to assessment days. 11. Participants willing to refrain from vigorous physical activity 12 hours prior to assessment days. 12. Participants willing to provide written consent. 13. Participants willing and able to understand and comply with the requirements of the study, consume the study IP as instructed, return for the required study period visits, comply with therapy prohibitions, (as mentioned in criteria 8 and criteria 10) and be able to complete the study.
Exclusion criteria
Exclusion criteria: 1. Female participants who are pregnant or who is planning for a pregnancy (either naturally with medical assistance or by invitro methods) or breastfeeding. 2. Participants having hypersensitivity or history of allergy to the study product or any other herbal ingredients/nutraceutical products. 3. Participants with evidence of malignancy or any concomitant end-state organ disease and/or laboratory abnormalities considered by investigators to be risky or that could interfere with data collection. 4. Female participants who have undergone surgical menopause. 5. Participants suffering from a metabolic disorder- confirmed through known history (uncontrolled diabetes, uncontrolled thyroid condition) and/or from any severe chronic disease (cancer, renal failure, HIV, immunodeficiency, hepatic or biliary disorders, arthritis, uncontrolled cardiac disease) or from any disease found to be interfering with the conduct of the study by the investigator. 6. Participants with a psychiatric diagnosis including anxiety or depression. 7. Participants with sleep disturbances and who are on prescription/over the counter/herbal/nutraceutical or any other system of therapy for sleep related concerns. 8. Participants with history of using hormonal therapy for menopause. 9. Participants with uncontrolled hypertension (systolic blood pressure greater than 160 mm Hg or diastolic blood pressure greater than 100 mm Hg) at screening. 10. Participants who are on anxiolytics, anti-depressants, antipsychotics, anticonvulsants, centrally acting corticosteroids, opioid pain relievers, hypnotics, and/or prescribed sleep medications. 11. Participants who have excessive habitual caffeine consumption (greater than 300 mg caffeine/day or greater or equal to 3 cups of caffeinated coffee/day) throughout the study period. 12. Participants who are consuming or planning to consume soy/estrogenic foods like soybean oil or other estrogenic diet supplements. 13. Participants with a history of drug and /or alcohol abuse at the time of screening. 14. Participants who have been treated with any investigational drug or investigational device within a period of 3 months prior to study entry. 15. Investigator is uncertain about the participant s capability or willingness to comply with the protocol requirements.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Change in scores of hot flushes from Menopause Rating Scale (MRS) assessment. 2. Change in hot flush frequency based on hot flush diary. 3. Change in climacteric symptom scores based on Menopause Rating Scale (MRS) assessment. Timepoint: 1. from baseline to end of the study. 2. from baseline to end of the study. 3. from baseline to end of the study. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change in perceived stress levels (Perceived stress scale PSS 10). 2. Change in Menopause specific quality of Life (MENQOL-I). 3. Change in improvement of the mood (POMS-2- Profile of Mood states) 4. Change in Sleep Quality Index. 5. Change in hormonal balance (Serum Estradiol)Timepoint: 1. from baseline to end of the study. 2. from baseline to end of the study. 3. from baseline to end of the study. 4. from baseline to end of the study. 5. from baseline to end of the study. | — |
Countries
India
Contacts
Public ContactT Vijaya Bhaskar
India Glycols Limited
Outcome results
None listed