Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study is to evaluate the effects of CL25216 on vasomotor symptoms in women during Perimenopause. Enrolled subjects will receive either CL25216 - 250 mg/day or placebo.
The purpose of this study is to evaluate the effects of CL25216 on vasomotor symptoms in women during perimenopause. A total of 80 female aged between40-55 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 CL25216 - 250 mg or placebo arms at 1:1ratio. The subjects will be instructed to take one capsule a day after breakfast for 105 days. Apart from primary and secondary outcomes, the study will also record the vital signs and adverse events to evaluate the herbal composition safety and tolerability. The safety assessment of the CL25216 will also include routine laboratory investigations on blood, urine and clinical chemistry at Screening/Randomisation visit and the final visit of the intervention.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CL25216 | Experimental | 250 mg to take one capsule a day after breakfast for 105 days |
|
| Placebo | Other | One capsule a day after breakfast for 105 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CL25216 | Dietary Supplement | 250mg to take one capsule a day after breakfast for 105 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline to the end of the study period in: Scores of Greene Climacteric Scale (GCS) | The Greene Scale is a validated instrument designed to provide a concise assessment of menopause symptoms. It consists of 21 items, each measuring the severity of climacteric symptoms on a scale from 0 (none) to 3 (severe), where 1 indicates mild and 2 indicates moderate symptoms. The total score ranges from 0 to 63, with higher scores reflecting more severe climacteric symptoms. | Day 1, 35, 70, and 105 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline to the end of the study period in: GCS sub-scale psychological symptoms | Psychological score is calculated from 1 to 11 items of GCS, ranges from 0 - 33, with higher scores reflecting more severe climacteric symptoms. | Day 1, 35, 70, and 105 |
| Change from baseline to the end of the study period in: GCS sub-scale scores: somatic/ physical symptoms |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Healthy overweight women aged between 40 to 55 years
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mr. T.V.N. Rao | Contact | +91 8331015069 | tvnrao.apex@gmail.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shree Hospitals | Recruiting | Vijayawada | India |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18074100 | Background | Deecher DC, Dorries K. Understanding the pathophysiology of vasomotor symptoms (hot flushes and night sweats) that occur in perimenopause, menopause, and postmenopause life stages. Arch Womens Ment Health. 2007;10(6):247-57. doi: 10.1007/s00737-007-0209-5. Epub 2007 Dec 12. | |
| 16894335 | Background | Heger M, Ventskovskiy BM, Borzenko I, Kneis KC, Rettenberger R, Kaszkin-Bettag M, Heger PW. Efficacy and safety of a special extract of Rheum rhaponticum (ERr 731) in perimenopausal women with climacteric complaints: a 12-week randomized, double-blind, placebo-controlled trial. Menopause. 2006 Sep-Oct;13(5):744-59. doi: 10.1097/01.gme.0000240632.08182.e4. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo |
| Dietary Supplement |
One capsule a day after breakfast for 105 days |
|
Somatic/ physical symptoms score is calculated from 12 to 18 items of GCS, ranges from 0 - 21, with higher scores reflecting more severe climacteric symptoms. |
| Day 1, 35, 70, and 105 |
| Change from baseline to the end of the study period in: GCS sub-scale scores: vasomotor symptoms. | Vasomotor symptoms score is calculated from 19 to 21 items of GCS, ranges from 0 - 9, with higher scores reflecting more severe climacteric symptoms. | Day 1, 35, 70, and 105 |
| Change from baseline to the end of the study period in: Resting Metabolic Rate (RMR) | RMR reflects the caloric expenditure necessary for life, without accounting for physical activity or digestion, measured by using metabolic analyzer. Increase in RMR is a sign of improved metabolism | Day 1, and 105 |
| Change from baseline to the end of the study period in: Positive and Negative Affect Schedule (PANAS-X) | The Positive and Negative Affect Schedule - Expanded Form (PANAS-X) is a validated self-report tool for assessing affective states, covering two broad dimensions: positive and negative affect. Each item has to be rated from 1 to 5 based on its severity. Each dimension is scored separately by summing the ratings of the individual items. As a result, the positive affect scale and the negative affect, with higher scores reflecting greater positive or negative affect, respectively. | Day 1, 35, 70, and 105 |
| Change from baseline to the end of the study period in: Quality of life questionnaire (Short Form -36) | The 36-Item Short Form (SF-36) is a self-reported questionnaire used to assess overall health and quality of life. It consists of 8 domains, each scored on a scale from 0 to 100. Higher scores indicate a better quality of life and improved health status. | Day 1, 35, 70, and 105 |
| Change from baseline to the end of the study period in: Sexual Function - Female Sexual Function Index (FSFI) | 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 | Day 1, 35, 70, and 105 |
| Change from baseline to the end of the study period in: The Hot Flush Weekly Weighted Score (HFWWS) | HFWW Score is calculated from a scale measuring the frequency and severity of hot flushes experienced daily for a week. Lower scores indicates better resolution of hot flushes | Day 1, 35, 70, and 105 |
| Change from baseline to the end of the study period in: Bodyweight | The subject's body weight is measured using a digital weighing scale. An improvement is indicated when the body weight falls within the normal range based on the subject's demographic characteristics. | Day 1, 35, 70, and 105 |
| Change from baseline to the end of the study period in: BMI | Body mass index is a calculated measure by considering the weight and height of a subject. A change in BMI from overweight to normal range is a positive indicator of healthy lifestyle. | Day 1, 35, 70, and 105 |
| Change from baseline to the end of the study period in: Scores of subjective self-assessments on hair quality | This is a subjective measurement of hair quality by considering the hair fall rate. The Highest Possible Score is 5. | Day 1, 35, 70, and 105 |
| Change from baseline to the end of the study period in: Skin wrinkle assessment | 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. | Day 1, 35, 70, and 105 |
| Change from baseline to the end of the study period in: Subject's self-assessment of skin Questionnaire | 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. | Day 1, 35, 70, and 105 |
| Change from baseline to the end of the study period in: Lipids | There is a clinically significant relationship between lipid metabolism and VMS like hot flashes and night sweats, especially in peri menopausal and postmenopausal women. Changes in lipid profiles may be both a cause and a consequence of hormonal shifts during this transition. Lower estrogen levels worsen lipid profiles and increases insulin resistance and central adiposity in perimenopusal/menopausal women. | Day 1, and 105 |
| Change from baseline to the end of the study period in: HOMA-IR | HOMA-IR is a simple and widely used method to estimate insulin resistance (IR) in perimenopause/menopause. HOMA-IR can be useful in assessing cardio metabolic risk in menopausal or postmenopausal women, especially those with vasomotor symptoms, which sometimes correlate with increased metabolic risk. | Day 1, and 105 |
| Change from baseline to the end of the study period in: FSH | It is a hormone produced by the pituitary gland and plays a crucial role in the reproductive systems of females. In perimenopause/menopause, the FSH level may rise disproportionately. Elevated FSH generally correlates with more frequent or severe hot flashes. | Day 1, and 105 |
| Change from baseline to the end of the study period in: LH | It is a hormone made by the pituitary gland that plays a key role in the reproductive system of females. In perimenopause/menopause, LH secretion becomes irregular and elevated, with occasional surges. Chronically elevated LH levels are seen in menopause. | Day 1, and 105 |
| Change from baseline to the end of the study period in: 17 beta-estradiol | 17β-Estradiol (E2) is the most potent and biologically active form of estrogen in humans produced majorly by ovaries, followed by adrenal. Low estradiol is a key driver of VMS like hot flashes, night sweats, and sleep disturbances. | Day 1, and 105 |
| Change from baseline to the end of the study period in: AMH | AMH (Anti-Müllerian Hormone) is a marker of ovarian reserve, reflecting the number of remaining follicles in the ovaries. Levels decline with age and become undetectable at menopause. AMH testing could help identify women at risk for early and intense vasomotor symptoms. | Day 1, and 105 |
| 19942836 | Background | Su HI, Freeman EW. Hormone changes associated with the menopausal transition. Minerva Ginecol. 2009 Dec;61(6):483-9. |
| 33095879 | Background | Santoro N, Roeca C, Peters BA, Neal-Perry G. The Menopause Transition: Signs, Symptoms, and Management Options. J Clin Endocrinol Metab. 2021 Jan 1;106(1):1-15. doi: 10.1210/clinem/dgaa764. |
| 26653408 | Background | Santoro N. Perimenopause: From Research to Practice. J Womens Health (Larchmt). 2016 Apr;25(4):332-9. doi: 10.1089/jwh.2015.5556. Epub 2015 Dec 10. |