Efficacy of CL22205 on Bone Mineral Density and Menopausal Symptoms

NCT06899243 | Not Yet Recruiting

• 1 other identifier: EB/MS/CL22205/24
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Menopausal Symptoms

Outcome Measures

Primary Outcomes (1)

• Change from baseline to the end of the study period in : Bone Mineral density (BMD) (g/cm2) of Lumbar spine (L1-L4)

  A low-dose X-ray is used to assess the bone mineral content (density) in specific areas, such as the lumbar spine at L1-L4 region. The results are typically expressed in terms of the T-score. If T scores ≥-1 signifies healthy bone, a range from -1 to -2.5 indicates osteopenia and a score of ≤-2.5 indicates osteoporosis.

  Screening/Baseline, Days 180 & 360

Secondary Outcomes (23)

• Change from baseline to the end of the study period in : Lean body mass through DEXA

  Screening/Baseline, Days 180 & 360

• Change from baseline to the end of the study period in : Scores of modified Kupperman index (mKI)

  Screening, Baseline/Day 1, Days 90,180 & 360

• Change from baseline to the end of the study period in: Hand grip-strength

  Baseline/Day 1, Days 90,180 & 360

• Change from baseline to the end of the study period in: Chalder Fatigue Scale (CFS)

  Baseline/Day 1, Days 90,180 & 360

• Change from baseline to the end of the study period in: Profile of Mood States (POMS-SF)

  Baseline/Day 1, Days 90,180 & 360

Other Outcomes (12)

• Telephonic evaluation: Modified Kupperman index (mKI)

  Monthly (Every month between evaluation days)

• Telephonic evaluation: Chalder Fatigue Scale (CFS)

  Monthly (Every month between evaluation days)

• Telephonic evaluation: Female Sexual Function Index (FSFI)

  Monthly (Every month between evaluation days)

Study Arms (2)

CL22205

EXPERIMENTAL

200 mg, One capsule a day after breakfast for 360 days

Dietary Supplement: CL22205

Placebo

OTHER

One capsule a day after breakfast for 360 days

Other: Placebo

Interventions

CL22205 DIETARY_SUPPLEMENT

200 mg, Route : Oral, One capsule a day after breakfast for 360 days

CL22205

Placebo OTHER

Route : Oral, One capsule a day after breakfast for 360 days

Placebo

Eligibility Criteria

• Age: 55 Years - 65 Years
• Gender Eligibility Details: Healthy females with Menopausal symptoms
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eetho Brands, Inc: lead

Study Officials

• Dr Arti Dibya, MBBS, MS DGO

  Vastalya Hospital and multispecialty Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vasu Goyal

CONTACT

2125550199; eethos.c@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2025
• First Posted: March 27, 2025
• Study Start: March 25, 2025
• Primary Completion (Estimated): May 10, 2026
• Study Completion (Estimated): August 30, 2026
• Last Updated: March 27, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share