Clinical trial NCT06899243: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Menopausal Symptoms
Lead sponsor: Eetho Brands, Inc
Sponsor class: INDUSTRY
First posted: 2025-03-27
Enrollment: 80
Sex: FEMALE
Minimum age (years): 55
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

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.

Primary outcomes:
measure: Change from baseline to the end of the study period in : Bone Mineral density (BMD) (g/cm2) of Lumbar spine (L1-L4)
timeFrame: Screening/Baseline, Days 180 & 360
Secondary outcomes:
measure: Change from baseline to the end of the study period in : Lean body mass through DEXA
timeFrame: Screening/Baseline, Days 180 & 360
measure: Change from baseline to the end of the study period in : Scores of modified Kupperman index (mKI)
timeFrame: Screening, Baseline/Day 1, Days 90,180 & 360
measure: Change from baseline to the end of the study period in: Hand grip-strength
timeFrame: Baseline/Day 1, Days 90,180 & 360
measure: Change from baseline to the end of the study period in: Chalder Fatigue Scale (CFS)
timeFrame: Baseline/Day 1, Days 90,180 & 360
measure: Change from baseline to the end of the study period in: Profile of Mood States (POMS-SF)
timeFrame: Baseline/Day 1, Days 90,180 & 360
measure: Change from baseline to the end of the study period in: Female Sexual Function Index (FSFI)
timeFrame: Baseline/Day 1, Days 90,180 & 360
measure: Change from baseline to the end of the study period in: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Baseline/Day 1, Days 90,180 & 360
measure: Change from baseline to the end of the study period in : Menopause Symptoms' Severity Inventory (MSSI-38)
timeFrame: Baseline/Day 1, Days 90,180 & 360
measure: Change from baseline to the end of the study period in : Mini Cog Questionnaire (Cognitive function)
timeFrame: Baseline/Day 1, Days 90,180 & 360
measure: Change from baseline to the end of the study period in : Subject's self-assessment of skin Questionnaire
timeFrame: Baseline/Day 1, Days 90,180 & 360
measure: Change from baseline to the end of the study period in : Scores of subjective self-assessment on hair quality
timeFrame: Baseline/Day 1, Days 90,180 & 360
measure: Change from baseline to the end of the study period in : Nail quality related questionnaire (NailQoL)
timeFrame: Baseline/Day 1, Days 90,180 & 360
measure: Change from baseline to the end of the study period in : Gastrointestinal symptoms questionnaire (GIS)
timeFrame: Baseline/Day 1, Days 90,180 & 360
measure: Change from baseline to the end of the study period in : Perceived Stress Scale (PSS-10)
timeFrame: Baseline/Day 1, Days 90,180 & 360
measure: Change from baseline to the end of the study period in : Visual assessment of skin wrinkles
timeFrame: Baseline/Day 1, Days 90,180 & 360
measure: Change from baseline to the end of the study period in : Core Lower Urinary Tract Symptom score (CLSS)
timeFrame: Baseline/Day 1, Days 90,180 & 360
measure: Change from baseline to the end of the study period in: Vaginal pH
timeFrame: Baseline/Day 1, Days 90,180 & 360
measure: Change from baseline to the end of the study period in : Skin hydration using moisture meter
timeFrame: Baseline/Day 1, Days 90,180 & 360
measure: Change from baseline to the end of the study period in : Bone specific serum ALP
timeFrame: Baseline/Day 1 & Day 360
measure: Change from baseline to the end of the study period in : Serum Osteoprotegerin
timeFrame: Baseline/Day 1 & Day 360
measure: Change from baseline to the end of the study period in : Serum Osteocalcin
timeFrame: Baseline/Day 1 & Day 360
measure: Change from baseline to the end of the study period in: Serum cortisol
timeFrame: Baseline/Day 1 & Day 360
measure: Change from baseline to the end of the study period in: Vaginal dryness
timeFrame: Baseline/Day 1, Days 90,180 & 360
Other outcomes:
measure: Telephonic evaluation: Modified Kupperman index (mKI)
timeFrame: Monthly (Every month between evaluation days)
measure: Telephonic evaluation: Chalder Fatigue Scale (CFS)
timeFrame: Monthly (Every month between evaluation days)
measure: Telephonic evaluation: Female Sexual Function Index (FSFI)
timeFrame: Monthly (Every month between evaluation days)
measure: Telephonic evaluation: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Monthly (Every month between evaluation days)
measure: Telephonic evaluation: Profile of Mood States (POMS-SF)
timeFrame: Monthly (Every month between evaluation days)
measure: Telephonic evaluation: Menopause Symptoms' Severity Inventory (MSSI-38):
timeFrame: Monthly (Every month between evaluation days)
measure: Telephonic evaluation: Subject's self-assessment of skin questionnaire
timeFrame: Monthly (Every month between evaluation days)
measure: Telephonic evaluation: Scores of subjective self-assessments on hair quality
timeFrame: Monthly (Every month between evaluation days)
measure: Telephonic evaluation: Nail quality related questionnaire (NailQoL)
timeFrame: Monthly (Every month between evaluation days)
measure: Telephonic evaluation: Core Lower Urinary Tract Symptom score (CLSS)
timeFrame: Monthly (Every month between evaluation days)
measure: Telephonic evaluation: Perceived Stress Scale (PSS-10)
timeFrame: Monthly (Every month between evaluation days)
measure: Telephonic evaluation: Gastrointestinal symptoms questionnaire (GIS)
timeFrame: Monthly (Every month between evaluation days)
Locations:
Study officials:
affiliation: Vastalya Hospital and multispecialty Centre
name: Dr Arti Dibya, MBBS, MS DGO
role: PRINCIPAL_INVESTIGATOR
References: