CTRI/2025/08/093452招募中不适用
The Effects of CL25216 on vasomotor symptoms in women during Perimenopause: a randomised, double-blind, placebo-controlled study
Apex CPG LLC2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2025年8月30日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Change from baseline to the end of the study period in: Scores of Greene Climacteric Scale (GCS)
研究概览
简要总结
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 between 40-55 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 1:1 ratio. 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, adverse events, Breast mammogram and endometrial thickness using Transvaginal Scan. 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 40.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- Female
入选标准
- •1.Healthy overweight women (BMI: 25-29 kg/m2) aged between 40 to 55 years with reports of changes in their menstrual cycle for at least 3 months.
- •2.Participants needed to have a total score of greater than 16 on the Greene Climacteric Scale (GCS), have an intact uterus and ovaries.
- •3.Early Perimenopausal Women according ‘The Stages of Reproductive Aging Workshop (STRAW) Classification (-2)’ irregular periods without skipping menstrual cycles and more than seven days difference in length of consecutive cycles.
- •4.Subjects with serum FSH >20 U/L on 3-5 days of menstrual cycle.
- •5.Subjects with normal pelvic TVS and breast mammogram.
- •6.Subjects with normal fasting blood glucose level (<125 mg/dl).
- •7.Subject understands the study procedures and provides signed informed consent to participate in the study.
- •8.Subjects with normal blood thyroid profile.
- •9.Females of childbearing potential who are sexually active must agree to use adequate non-hormonal contraception and can neither be pregnant nor lactating from screening throughout the duration of the study.
- •10.Clinical screening including vital signs, electrocardiogram (ECG) and laboratory evaluations (including clinical chemistry, haematology, 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.
排除标准
- •1.History of cerebrovascular disease, thrombo-embolic disorders, heart attack, or angina at any time or thrombophlebitis within the last 5 years, on anti-coagulant or anti-platelet drugs daily for any conditions.
- •2.Subjects who had received hormonal treatment or any other herbal products in the previous 6 months.
- •3.Subjects underwent treatment for COVID 19 within last 3 months or tested positive during the study will be excluded.
- •4.Subjects diagnosed with ovarian cysts greater than or equal to 4 cm or any underlying pathology in pelvic transvaginal sonography (TVS) performed during screening.
- •5.Chronic or acute life stressors relating to a major life change, experiencing depression and/or receiving medication for such illness or disorders, receiving statins or other drugs known to impact on steroid hormone levels.
- •6.Subjects having active gall bladder disease, gynaecological or breast surgery in the last 6 months.
- •7.History of breast, endometrial, other gynaecological cancer at any time or other cancer within the last 5 years.
- •8.Subjects with abnormal ECG.
- •9.Pregnant and breast feeding female.
- •10.History of hypersensitivity reactions attributed to investigational product (IP) or its components or related products.
- •11.Donation/loss of blood 1 unit or 350 mL within 90 days prior to receiving the first dose of study medication.
- •12.Use of any recreational drugs (cocaine, amphetamine, barbiturates, benzodiazepines, cannabinoids, and morphine).
- •13.History of clinically significant illness or any other medical disorder that may interfere with subject treatment, assessment, or compliance with the protocol.
- •15.Any condition that in opinion of the investigator, does not justify the subjects’ participation in the study.
- •16.Subjects with a high blood pressure at screening (systolic blood pressure greater than or equal to 160 mmHg or diastolic blood pressure greater than or equal to 100 mmHg).
- •17.Subjects with progressive systemic diseases (e.g. tuberculosis, leucosis, collagenosis, multiple sclerosis, AIDS, HIV infections, Hepatitis B surface antigen or Hepatitis C virus (HCV) antibodies or other auto-immune diseases).
- •19.High alcohol intake (greater than 2 standard drinks per day), smokers (greater than 5 cigarettes per day).
结局指标
主要结局
Change from baseline to the end of the study period in: Scores of Greene Climacteric Scale (GCS)
时间窗: Day 1, Day 35 (±10 days), Day 70 (±10 days) and Day 105 (±10 days)
次要结局
- Change from baseline to the end of the study period in:(GCS sub-scale (psychological symptoms, somatic/physical symptoms, and vasomotor symptoms.) scores)
- Change from baseline to the end of the study period in: Resting Metabolic Rate (RMR)(Day 1 and Day 105 (±10 days))
- Change from baseline to the end of the study period in: Positive and Negative Affect Schedule (PANAS-X) scores(Day 1, Day 35 (±10 days), Day 70 (±10 days) and Day 105 (±10 days))
- Change from baseline to the end of the study period in: Quality of life questionnaire (Short Form -36)(Day 1, Day 35 (±10 days), Day 70 (±10 days) and Day 105 (±10 days))
- Change from baseline to the end of the study period in Sexual Function: Female Sexual Function Index (FSFI)(Day 1, Day 35 (±10 days), Day 70 (±10 days) and Day 105 (±10 days))
- Change from baseline to the end of the study period in: The Hot Flush Weekly Weighted Score (HFWWS)(Day 1, Day 35 (±10 days), Day 70 (±10 days) and Day 105 (±10 days))
- Change from baseline to the end of the study period in: Bodyweight and BMI(Day 1, Day 35 (±10 days), Day 70 (±10 days) and Day 105 (±10 days))
- Change from baseline to the end of the study period in: Scores of subjective self-assessments on hair quality(Day 1, Day 35 (±10 days), Day 70 (±10 days) and Day 105 (±10 days))
- Change from baseline to the end of the study period in: Skin wrinkle assessment(Day 1, Day 35 (±10 days), Day 70 (±10 days) and Day 105 (±10 days))
- Change from baseline to the end of the study period in: Subject’s self-assessment of skin Questionnaire(Day 1, Day 35 (±10 days), Day 70 (±10 days) and Day 105 (±10 days))
- Change from baseline to the end of the study period in: Serum biomarkers (lipids, HOMA-IR, FSH, LH, 17 beta-estradiol and AMH)(Day 1 and Day 105 (±10 days))
研究者
Mr Prason Kumar J
Laila Nutra Private Limited
研究点 (2)
Loading locations...
相似试验
已完成
不适用
Efficacy of herbal supplement to improve menstrual discomfort and quality of life.CTRI/2025/01/078999Eetho Brands Inc (DBA: Dose)80
尚未招募
不适用
A clinical study to asses the effect of CL22205 on bone mineral density and menopausal symptoms in womenCTRI/2025/03/083217Eetho Brands Inc80
尚未招募
2 期
A clinical trial where participants will be divided into two groups, with drug intervention as Venlafaxine in one and placebo in other group and outcome will be analysed on basis of vasomotor symptoms.CTRI/2025/01/079138AIIMS, New Delhi64
尚未招募
不适用
A Study to Test the Effectiveness of Hair care Tonic for Hair Growth in Women.CTRI/2025/03/082536Bioneer46
招募中
2 期
A Chronic Pain Master Protocol (CPMP): A Study of LY4065967 in Participants With Diabetic Peripheral Neuropathic PainNCT07285018Eli Lilly and Company150