Efficacy of CL22205 on Bone Mineral Density and Menopausal Symptoms

Official title

The Effect of CL22205 on Bone Mineral Density and Menopausal Symptoms in Women: A Randomized, Double-blind, Placebo Controlled Clinical Trial

Overview

The purpose of this study is to evaluate the effect of CL22205 on bone mineral density and menopausal symptoms in women.

Detailed description

A total of 80 healthy female subjects aged between 55 and 65 years will be included in the study. Assessment of inclusion and exclusion criteria will be done based on clinical and laboratory investigations. The eligible subjects will be randomized as per the computer-generated randomization list. The subjects will be assigned to either CL22205 - 200 mg or placebo arms at 1:1 ratio. The subjects will be instructed to take one capsule a day after breakfast for 360 days. Apart from primary and secondary outcomes, the study will also record the vital signs and adverse events to evaluate the herbal composition's safety and tolerability. The safety assessment of the CL22205 will also include routine laboratory investigations on blood, urine and clinical chemistry at screening and the final visit of the intervention.

Interventions

• Dietary supplement CL22205
  200 mg, Route : Oral, One capsule a day after breakfast for 360 days
• Other Placebo
  Route : Oral, One capsule a day after breakfast for 360 days

Primary outcome measures

• Change from baseline to the end of the study period in : Bone Mineral density (BMD) (g/cm2) of Lumbar spine (L1-L4) [Time frame: Screening/Baseline, Days 180 & 360]

Secondary outcome measures (12)

• Change from baseline to the end of the study period in : Lean body mass through DEXA [Time frame: Screening/Baseline, Days 180 & 360]
• Change from baseline to the end of the study period in : Scores of modified Kupperman index (mKI) [Time frame: Screening, Baseline/Day 1, Days 90,180 & 360]
• Change from baseline to the end of the study period in: Hand grip-strength [Time frame: Baseline/Day 1, Days 90,180 & 360]
• Change from baseline to the end of the study period in: Chalder Fatigue Scale (CFS) [Time frame: Baseline/Day 1, Days 90,180 & 360]
• Change from baseline to the end of the study period in: Profile of Mood States (POMS-SF) [Time frame: Baseline/Day 1, Days 90,180 & 360]
• Change from baseline to the end of the study period in: Female Sexual Function Index (FSFI) [Time frame: Baseline/Day 1, Days 90,180 & 360]
• Change from baseline to the end of the study period in: Pittsburgh Sleep Quality Index (PSQI) [Time frame: Baseline/Day 1, Days 90,180 & 360]
• Change from baseline to the end of the study period in : Menopause Symptoms' Severity Inventory (MSSI-38) [Time frame: Baseline/Day 1, Days 90,180 & 360]
• Change from baseline to the end of the study period in : Mini Cog Questionnaire (Cognitive function) [Time frame: Baseline/Day 1, Days 90,180 & 360]
• Change from baseline to the end of the study period in : Subject's self-assessment of skin Questionnaire [Time frame: Baseline/Day 1, Days 90,180 & 360]
• Change from baseline to the end of the study period in : Scores of subjective self-assessment on hair quality [Time frame: Baseline/Day 1, Days 90,180 & 360]
• Change from baseline to the end of the study period in : Nail quality related questionnaire (NailQoL) [Time frame: Baseline/Day 1, Days 90,180 & 360]

Eligibility criteria

Inclusion criteria

• Healthy females aged between 55 and 65 years with a Body mass index (BMI) of approximately 24 and 29 kg/m2.
• Women with menopausal symptoms (modified Kupperman index scores 15-29), absence of menstrual cycle for past 12-months; follicle-stimulating hormone (FSH) > 30 mIU/mL; estradiol < 30 pg/mL.
• Subjects who are under standard supplementation of Vitamin D3 (cholecalciferol) and calcium carbonate.
• Subjects with osteopenia (T score of spine between -1 and -2.5 in DEXA).
• 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.
• Subject understands the study procedures and provides signed informed consent to participate in the study.
• Normal vital signs, including electrocardiogram (ECG) and laboratory evaluations (including clinical biochemistry, haematology, lipid profile, thyroid 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

• Consumption of functional food or supplement that modifies body composition, during or 6 months prior to the study.
• History of cerebrovascular disease, thrombo-embolic disorders, heart attack, or angina at any time or thrombophlebitis within the last 5 years.
• Subjects on anti-coagulant or anti-platelet drugs on a daily basis for any conditions.
• Presence of chronic diseases that prevent the performance of a physical exercise program (disabling arthropathies, moderate / severe chronic lung disease, arrhythmias, etc.).
• High alcohol intake (>2 standard drinks per day), or recreational drugs (such as cocaine, methamphetamine, marijuana, etc.) or psychiatric drug users.
• Smokers or tobacco users.
• Inability to understand informed consent.
• Serious or terminal illnesses.
• Fasting blood glucose level >125 mg/dl.
• Subjects with a high blood pressure at screening (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥ 90 mmHg).
• Subjects who had any hormonal therapy, metformin or any other herbal products in the past 3 months.
• Hypothyroidism, hyperthyroidism, hyperprolactinemia, Cushing's syndrome and congenital adrenal hyperplasia, following a special diet for the past 3 months.
• Taking drugs affecting insulin sensitivity or lipid and hormonal profiles, including glucocorticoids, ovulation-stimulating drugs, anti-obesity, anti-diabetes, anti-hypertensive, anti-estrogenic, anti-androgenic during the last 3 months (except the usual drugs of the subjects).
• Active gall bladder disease, gynaecological (including hysterectomy) or breast surgery in the last 6 months.
• Subjects who are being treated for liver cancer or cirrhosis, chronic renal failure, congestive heart failure.
• Subjects with a systemic disease including tuberculosis, leucosis, collagenosis, multiple sclerosis or other autoimmune diseases.
• History of breast, endometrial, other gynaecological cancer at any time or other cancer within the last 5 years.
• History of hypersensitivity reactions attributed to investigational product (IP) or its components or related products.
• 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.
• History of clinically significant illness or any other medical disorder that may interfere with subject treatment, assessment or compliance with the protocol.
• Participated in a clinical study with an investigational drug or biologic within the last 30 days.
• Any condition that in opinion of the investigator, does not justify the subjects' participation in the study.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Health services research

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06899243 · EB/MS/CL22205/24

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗