Efficacy of CL22205 on Bone Mineral Density and Menopausal Symptoms

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.

Dual-energy X-ray absorptiometry (DEXA) uses two X-ray beams with different energies to measure lean body mass in Kilograms. Higher ranges reflect a greater proportion of lean tissue.

The modified Kupperman Index (mKI) is a tool used to assess the severity of menopausal symptoms. The total score ranges from 0 to 63, calculated as the sum of all items by the weighting factor. Scores ranging from 0-6, 7-15, 16-30, and >30 were used to rate the degree of severity as none, mild, moderate, and severe, respectively.

Grip strength was a measure of muscular strength (in kgs) or the maximum force/tension generated by one's forearm muscles. The Hand grip strength was measured using digital hand dynamometer.

The Fatigue Scale, sometimes referred to as the Chalder Fatigue Scale, is a self-administered questionnaire for measuring the extent and severity of fatigue within both clinical and non-clinical, epidemiological populations. Items are rated on a 4-point Likert scale (0, 1, 2, 3), with higher scores indicating greater fatigue. The respondent's global score can range from 0 to 33.

POMS-SF is a commonly used tool for examining people's emotional states. The total score ranges from 0 to 100. A Total Mood Disturbance (TMD)is calculated by subtracting the vigour score from the total sum of the raw scores for tension, depression, anger, fatigue, and confusion. The lower scores indicative of people with more stable mood profiles.

The FSFI was developed as a brief, easy-to-administer, self-report tool for assessing key dimensions or domains of sexual function and quality of life in various populations of women. Female Sexual Function Index (FSFI), a widely used tool with six domains (Arousal, Desire, Orgasm, Lubrication, Satisfaction, and Pain). The total FSFI score ranges from minimum score of 2 and maximum score of 36. Greater Scores indicates better sexual function.

The Pittsburgh Sleep Quality Index (PSQI) is a widely used self-report questionnaire that assesses sleep quality over a one-month time interval. Respondents are asked to indicate how frequently they have experienced certain sleep difficulties over the past month and to rate their overall sleep quality. Scores for each question range from 0 to 3, global PSQI score range of 0-21, with higher scores indicating more acute sleep disturbances.

The Menopause Symptoms' Severity Inventory (MSSI-38) is a comprehensive tool used to assess menopausal symptoms in terms of both frequency and intensity. MSSI-38 is scored using a five-point Likert scale. The total score ranges from 0 to 152. As the score increases, severity and intensity of menopausal symptoms increases.

The Mini-Cog was one such neuropsychological test that has been effective in detecting patients with dementia. It consists of a three-item recall test and a clock drawing test (CDT). For the three-recall score, ranges from 0-3, and in CDT, subjects were asked to spontaneously draw a circular clock displaying a particular time (11:10). 2 points for a normal clock or 0 (zero) points for an abnormal clock drawing (Lowest possible Score: 0 and the highest possible score: 5). The 3-item recall and clock drawing scores were added together to get the final score. Scores ranges from 0-5, with an increase in score reflect an improvement in cognitive function.

As the perception of the skin radiance is subjective, a self-assessment has been performed through a questionnaire. The scores range from 0 to 10, with higher scores indicating better skin quality in terms of complexion, smoothness, texture, elasticity, and hydration.

This is a subjective measurement of hair quality by considering the hair fall rate. The Highest Possible Score is 5.

The Nail Quality of Life (NailQOL) is a measure or assessment used to evaluate how nail condition (such as nail diseases or abnormalities) impacts an individual overall quality of life. NailQOL of 15 questions will be administered and each question will be scored on a 0-100 scale, where 0 = never; 25 = rarely; 50 = sometimes; 75 = often; 100 = all the time. The average total score ranges between 0 and 100. An increase in Nail QoL scores indicates worsening quality of life.

GIS questionnaire includes questions about the severity of GI symptoms (Abdominal pain, Epigastric pain, general intestinal symptoms, dysphagia, and stools). The total highest possible Score is 30 and the total lowest possible score is 0.

The perceived stress scale (PSS) is the most widely used psychological questionnaire containing ten questions for measuring the perception of stress. The total highest possible Score is 30 and the total lowest possible score is 0.

Visual assessment of skin wrinkles used to evaluate the appearance of skin aging and to determine the severity of wrinkles. This kind of assessment is typically done by a healthcare professional or dermatologist and involves examining the skin surface to identify and score wrinkles. Grade ranging from 0 to 9 where 0 represents no wrinkles and 9 represents deep wrinkles.

The core lower urinary tract symptom score (CLSS) questionnaire addresses 10 important lower urinary tract symptoms, which are reported as the most influential symptoms that have a negative impact on the QoL of symptomatic men and women. The total score ranges between 0 and 30. Higher scores reflect greater symptom severity.

The vaginal pH was assessed by using a pH test strip.

Skin hydration means the moisture content present on the surface of the skin. This will be done by using a moisture meter.

Bone-specific ALP, produced by osteoblasts, is an enzyme vital for bone mineralization. It's a marker for bone formation and turnover, with elevated levels indicating increased bone formation (e.g., Paget's disease) and decreased levels indicating reduced bone formation (e.g., osteoporosis).

Osteoprotegerin (OPG), produced by osteoblasts, is a key regulator of bone resorption. It inhibits osteoclast differentiation and activity, thereby influencing bone density. OPG also plays a role in vascular calcification and cardiovascular disease. As a marker of bone turnover, elevated OPG levels are associated with increased bone density (e.g., osteopetrosis, Paget's disease), while decreased levels correlate with reduced bone density, osteoporosis, and increased fracture risk.

Osteocalcin, a protein hormone secreted by osteoblasts, is fundamental to bone mineralization and calcium homeostasis. It promotes calcium deposition, modulates bone resorption, and participates in glucose metabolism and fat mass regulation. As a biomarker of bone formation, elevated osteocalcin levels indicate increased bone turnover (e.g., osteoporosis, Paget's disease), while decreased levels suggest reduced bone formation (e.g., osteomalacia, rickets).

Cortisol, a steroid hormone synthesized by the adrenal glands, is essential for the body's stress response, glucose regulation, and macronutrient metabolism. Maintaining appropriate cortisol levels is critical for women's overall health.

The vaginal dryness intensity was assessed with an analog visual scale (length 10 cm), considering 10 as the maximum vaginal dryness and 0 as symptom absence.

The modified Kupperman Index is a tool used to assess the severity of menopausal symptoms. The total score ranges from 0 to 63, with scores of 0-6, 7-15, 16-30, and over 30 used to classify the severity as none, mild, moderate, and severe, respectively.

Chalder Fatigue Scale is used to measuring the extent and severity of fatigue. Items are rated on a 4-point Likert scale (0, 1, 2, 3), with higher scores indicating greater fatigue. The respondent's global score can range from 0 to 33.

The Female Sexual Function Index was developed for assessing key dimensions or domains of sexual function and quality of life in women. The total FSFI score ranges from 2 to 36. Greater Scores indicates better sexual function.

The Pittsburgh Sleep Quality Index is a widely used self-report questionnaire that assesses sleep quality over a one-month time interval. Global PSQI score range of 0-21, with higher scores indicating more acute sleep disturbances.

Profile of Mood States is a commonly used tool for examining people's emotional states. The total score ranges from 0 to 100. The lower scores are indicative of people with more stable mood profiles.

The Menopause Symptoms' Severity Inventory is a comprehensive tool used to assess menopausal symptoms in terms of both frequency and intensity. The total score ranges from 0 to 152. As the score increases, severity and intensity of menopausal symptoms increases.

As the perception of the skin radiance is subjective, a self-assessment has been performed through a questionnaire. The score ranges from 0to 10, with higher scores indicating better skin quality in terms of complexion, smoothness, texture, elasticity, and hydration.

This is a subjective measurement of hair quality by considering the hair fall rate. The Highest Possible Score is 5.

The Nail Quality of Life is a measure or assessment used to evaluate how nail condition (such as nail diseases or abnormalities) impacts an individual overall quality of life. Na of 15 questions will be administered, and each question will be scored on a 0-100 scale, where 0 = never; 25 = rarely; 50 = sometimes; 75 = often; 100 = all the time. The average total score ranges between 0 and 100. An increase in Nail QoL scores indicates worsening quality of life.

The core lower urinary tract symptom score questionnaire addresses 10 important lower urinary tract symptoms. The total score ranges between 0 and 30. Higher scores reflect greater symptom severity.

The perceived stress scale is the most widely used psychological questionnaire containing ten questions for measuring the perception of stress. The total highest possible score is 30 and the total lowest possible score is 0.

Gastrointestinal symptoms questionnaire includes questions about the severity of GI symptoms (Abdominal pain, Epigastric pain, general intestinal symptoms, dysphagia, and stools). The total highest possible Score is 30 and the total lowest possible score is 0.