None listed
Conditions
Interventions
None listed
Sponsors
CLS.Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Female subjects aged between 40 and 50 years with a Body Mass Index (BMI) of approximately 22 to 29 kg/m2 and sexually active. 2.Early Premenopausal Women according ‘The Stages of Reproductive Aging Workshop (STRAW) Classification (-2)’ irregular periods without skipping menstrual cycles and more than seven days difference in length of consecutive cycles. 3.Subjects with serum FSH >20 U/L on 3-5 days of menstrual cycle. 4.Women with Menopause Rating Scale (MRS) total score =18 points, reflecting moderate to severe menopausal symptoms. 5.Subjects with normal fasting blood glucose level ( 6.Subject understands the study procedures and provides signed informed consent to participate in the study. 7.Subjects with normal blood thyroid profile. 8.Females of childbearing potential who are sexually active must agree to use adequate contraception and can neither be pregnant nor lactating from screening throughout the duration of the study. 9.Clinical screening including vital signs, electrocardiogram (ECG) and laboratory evaluations (including clinical chemistry, haematology, and complete urinalysis) within the reference range for the testing laboratory or the results are deemed not clinically significant for inclusion into this study by the investigator.
Exclusion criteria
Exclusion criteria: 1.History of cerebrovascular disease, thrombo-embolic disorders, heart attack, or angina at any time or thrombophlebitis within the last 5 years, on anti-coagulant or anti-platelet drugs daily for any conditions. 2.Patients who had received with hormonal treatment or any other herbal products in the previous 6 months. 3.Subjects underwent treatment for COVID 19 within last 3 months or tested positive during the study will be excluded. 4.Subjects diagnosed with ovarian cysts = 4 cm in pelvic ultrasonography (USG) performed during screening. 5.Hormonal therapy within 3 months of recruitment. 6.Chronic or acute life stressors relating to a major life change, experiencing depression and or receiving medication for such illness or disorders, receiving statins or other drugs known to impact on steroid hormone levels. 7.Subjects having active gall bladder disease, gynaecological or breast surgery in the last 6 months. 8.History of breast, endometrial, other gynaecological cancer at any time or other cancer within the last 5 years. 9.Subjects with abnormal ECG. 10.Pregnant and breast feeding female. 11.History of hypersensitivity reactions attributed to investigational product (IP) or its components or related products. 12.Donation/loss of blood 1 unit or 350 mL within 90 days prior to receiving the first dose of study medication. 13.Use of any recreational drugs (cocaine, amphetamine, barbiturates, benzodiazepines, cannabinoids, and morphine). 14.History of clinically significant illness or any other medical disorder that may interfere with subject treatment, assessment, or compliance with the protocol. 15.Participated in a clinical study with an investigational drug or biologic within the last 30 days. 16.Any condition that in opinion of the investigator, does not justify the subjects’ participation in the study. 17.Subjects with a high blood pressure at screening (systolic blood pressure greater than or equal to 160 mmHg or diastolic blood pressure greater than or equal to 100 mmHg). 18.Subjects with progressive systemic diseases (e.g. tuberculosis, leucosis, collagenosis, multiple sclerosis, AIDS, HIV infections, Hepatitis B surface antigen or Hepatitis C virus (HCV) antibodies or other auto-immune diseases). 19.Evidence or history of clinically significant (in the judgment of the Investigator) haematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, neurologic diseases, or malignancies, hypothyroidism. 20.High alcohol intake (greater than 2 standard drinks per day), smokers (greater than 5 cigarettes per day).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in the scores of menopausal rating scale (MRS)Timepoint: Baseline,Day30,Day60,Day120 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in Grade of Acne vulgaris based on simple acne grading systemTimepoint: Baseline, Day30, Day60 and Day120;Change from baseline in No of follicles in ovaries (using pelvic ultrasonography (USG))Timepoint: Screening, Day30, Day60 and Day120;Change from baseline in Scores of ‘the Hot Flush Weekly Weighted Score (HFWWS)’ calculated from daily recorded number of hot flushes Timepoint: Baseline, Day30, Day60 and Day120;Change from baseline in Scores of Integrative Medicine Outcome Scale (IMOS)Timepoint: Day30, Day60 and Day120;Change from baseline in Scores of Integrative Medicine Patient Satisfaction Scale (IMPSS).Timepoint: Day30, Day60 and Day120;Change from baseline in Scores of subjective self-assessment on hair qualityTimepoint: Baseline, Day30, Day60 and Day120;Change from baseline in Serum hormone levels including Follicle stimulating hormone (FSH), Luteinizing hormone (LH), Anti-mullerian hormone (AMH), and 17ß-Estradiol (E2) on 3-5 days of menstrual cycle.Timepoint: Baseline and Day120;Change from Scores of the Menstrual symptoms questionnaire (MSQ)Timepoint: Baseline, Day30, Day60 and Day120 | — |
Countries
India
Contacts
Public ContactMr Ajjarapu Srinivasu
CLS Pvt Ltd
Outcome results
None listed