None listed
Conditions
Interventions
Intervention1: CL22209: 50 mg, One capsule a day after breakfast for 360 days
Intervention2: CL22209: 100 mg, One capsule a day after breakfast for 360 days
Intervention3: CL22209: 50 mg, One capsule
Sponsors
CLS Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Healthy females aged between 55 and 65 years with a Body mass index (BMI) of approximately 24 and 29 kg per meter square. 2.Women with menopausal symptoms (modified Kupperman index scores 25 to 35), absence of menstrual cycle for past 12 months; follicle-stimulating hormone (FSH) greater than 30 mIU/mL; estradiol less than 30 pg/mL. 3.Subjects who are under standard supplementation of Vitamin D3 (cholecalciferol) and calcium carbonate. 4.Subjects with osteopenia (T score of Lumbar between -1 and - 2.5 in DEXA). 5.Must also be experiencing 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.Subjects with normal Thyroid profile. 7.Subjects agreed to restrict consumption of Soy products including Tofu; legumes with higher levels phytoestrogens, caffeinated and carbonated products 3 days prior to the study visit. 8.Subject understands the study procedures and provides signed informed consent to participate in the study. 9.Normal vital signs, including electrocardiogram (ECG) and laboratory evaluations (including clinical biochemistry, haematology, lipid profile 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. Consumption of functional food or supplement that modifies body composition, during or 6 months prior to the study. 2. History of cerebrovascular disease, thrombo-embolic disorders, heart attack, or angina at any time or thrombophlebitis within the last 5 years. 3. Subjects on anti-coagulant or anti-platelet drugs on a daily basis for any conditions. 4. Presence of chronic diseases that prevent the performance of a physical exercise program (disabling arthropathies, moderate / severe chronic lung disease, arrhythmias, etc.). 5. High alcohol intake (greater than 2 standard drinks per day),or recreational drugs (such as cocaine, methamphetamine, marijuana, etc.) or psychiatric drug users. 6. Smokers or tobacco users. 7. Inability to understand informed consent. 8. Serious or terminal illnesses. 9. Subjects with uncontrolled diabetes (FBG greater than or equal to 130) and uncontrolled hypertension (greater than or equal to 140/90). 10. Subjects who have received any form of hormonal therapy within the past three months, including treatments affecting glucose and lipid metabolism,or hormonal profiles (e.g., glucocorticoids, ovulation-inducing agents, anti-obesity medications, anti-estrogenic or anti-androgenic therapies), or who have consumed herbal products known to influence metabolic or endocrine function. 11. Hypothyroidism, hyperthyroidism, hyperprolactinemia, Cushings syndrome and congenital adrenal hyperplasia, following a special diet for the past 3 months. 12. Active gall bladder disease, gynaecological (including hysterectomy) or breast surgery in the last 6 months. 13. Subjects who are being treated for liver cancer or cirrhosis, chronic renal failure, congestive heart failure. 14. Subjects with a systemic disease including tuberculosis, leucosis, collagenosis, multiple sclerosis or other autoimmune diseases. 15. History of breast, endometrial, other gynaecological cancer at any time or other cancer within the last 5 years. 16. History of hypersensitivity reactions attributed to investigational product (IP) or its components or related products. 17. History of positive hepatitis screening including Hepatitis B surface antigen or Hepatitis C virus (HCV) antibodies or subjects with human immunodeficiency virus (HIV) and /or syphilis. 18. History of clinically significant illness or any other medical disorder that may interfere with subject treatment, assessment or compliance with the protocol. 19. Participated in a clinical study with an investigational drug or biologic within the last 30 days. 20. Any condition that in opinion of the investigator, does not justify the subjects participation in the study. 21. Vegans (individuals who do not consume dairy products and legumes).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline to the end of the study period in: Bone Mineral density (BMD) (g/cm2) of Lumbar spine (L1-L4)Timepoint: Screening visit (3-5 days prior to randomization visit), Follow up Visit (Day 180) and Final Visit (Day 360) | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline to the end of the study period in: Scores of modified Kupperman index (mKI)Timepoint: Screening visit (3-5 days prior to randomization visit), Randomization Visit (Day 01), Follow up Visit (Day 90), Follow up Visit (Day 180) and Final Visit (Day 360);Change from baseline to the end of the study period in: Lean body mass through DEXATimepoint: Screening visit (3-5 days prior to randomization visit), Follow up Visit (Day 180) and Final Visit (Day 360);Change from baseline to the end of the study period in: Hand grip-strengthTimepoint: Randomization Visit (Day 01), Follow up Visit (Day 90), Follow up Visit (Day 180) and Final Visit (Day 360);Change from baseline to the end of the study period in: Chalder Fatigue Scale (CFS)Timepoint: Randomization Visit (Day 01), Follow up Visit (Day 90), Follow up Visit (Day 180) and Final Visit (Day 360);Change from baseline to the end of the study period in: Profile of Mood States (POMS-SF)Timepoint: Randomization Visit (Day 01), Follow up Visit (Day 90), Follow up Visit (Day 180) and Final Visit (Day 360);Change from baseline to the end of the study period in: Female Sexual Function Index (FSFI)Timepoint: Randomization Visit (Day 01), Follow up Visit (Day 90), Follow up Visit (Day 180) and Final Visit (Day 360);Change from baseline to the end of the study period in: Athens Insomnia Scale (AIS)Timepoint: Randomization Visit (Day 01), Follow up Visit (Day 90), Follow up Visit (Day 180) and Final Visit (Day 360);Change from baseline to the end of the study period in: Menopause Symptoms Severity Inventory (MSSI-38)Timepoint: Randomization Visit (Day 01), Follow up Visit (Day 90), Follow up Visit (Day 180) and Final Visit (Day 360);Change from baseline to the end of the study period in: Mini Cog questionnaire (Cognitive function)Timepoint: Randomization Visit (Day 01), Follow up Visit (Day 90), Follow up Visit (Day 180) and Final Visit (Day 360);Change from baseline to the end of the study period in : Subjects self- | — |
Countries
India
Contacts
Public ContactMr Ajjarapu Srinivasu
CLS Pvt Ltd
Outcome results
None listed