CTRI/2025/01/078919已完成不适用
A randomized, double-blind placebo-controlled study to evaluate the efficacy of CL22209 on menstrual symptoms, ovarian morphology and quality of life.
CLS Pvt Ltd3 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2025年1月28日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 3
- 主要终点
- Change from baseline to the end of the study period in:
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of CL22209 on menstrual symptoms, ovarian morphology and quality of life. A total of 90 female subjects aged between 25 and 45 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 CL22209 - 50 mg or CL22209 - 100 mg or placebo arm at 1:1:1 ratio. The subjects will be instructed to take one capsule a day after breakfast for 84 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 CL22209 will also include routine laboratory investigations on blood, urine and clinical chemistry at screening 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
- 25.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •1.Healthy females aged between 25 and 45 years with a Body Mass Index (BMI) of approximately 20 to 29.9 kg/m
- •2.Subjects fulfilling the diagnostic criteria for PMS according to DSM5-TR.(Note: participants who met the above criteria and have experienced the symptoms for at least two consecutive cycles before randomization) 3.Subjects with normal thyroid profile.
- •4.Subjects who are non-smokers and non-alcohol user.
- •5.Subject understands the study procedures and provides signed informed consent to participate in the study.
- •6.Females of childbearing potential who are sexually active must agree to use adequate non-hormonal contraception during the study.
- •7.Normal vital signs, including electrocardiogram (ECG) and laboratory evaluations (including clinical chemistry, hematology, 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 any gynaecological disorders which effects the study indication.
- •2.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 on a daily basis for any conditions.
- •3.Subjects who had any hormonal therapy, metformin or any other herbal products in the past 3 months.
- •4.Hypothyroidism, hyperthyroidism, hyperprolactinemia, Cushings 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).
- •5.Active gall bladder disease, gynaecological or breast surgery in the last 6 months.
- •6.Subjects underwent hysterectomy.
- •7.History of breast, endometrial, other gynaecological cancer at any time or other cancer within the last 5 years.
- •8.Pregnant and lactating mothers.
- •9.History of hypersensitivity reactions attributed to investigational product (IP) or its components or related products.
- •10.History of positive hepatitis, including Hepatitis B surface antigen or Hepatitis C virus (HCV) antibodies or subjects with human immunodeficiency virus (HIV) and or syphilis.
- •11.History of clinically significant illness or any other medical disorder that may interfere with subject treatment, assessment or compliance with the protocol.
- •12.Participated in a clinical study with an investigational drug or biologic within the last 60 days.
- •13.Any condition that in opinion of the investigator, does not justify the subjects participation in the study.
- •14.Subjects who are being treated for liver cancer or cirrhosis, chronic renal failure, congestive heart failure.
- •15.Subjects with a systemic disease including tuberculosis, leucosis, collagenosis, multiple sclerosis or other autoimmune diseases.
- •16.Subjects with a high blood pressure at pre-screening (systolic blood pressure greater than or equal to 140 mmHg or diastolic blood pressure greater than or equal to 90 mmHg).
- •17.Consumption of recreational drugs (such as cocaine, methamphetamine, marijuana, etc.) or psychiatric drug users.
结局指标
主要结局
Change from baseline to the end of the study period in:
时间窗: Menstrual cycles 1, 2, 3, 4, 5 & 6
Total score of PMS using Daily Record of Severity of Problems (DRSP)
时间窗: Menstrual cycles 1, 2, 3, 4, 5 & 6
次要结局
- Change from baseline to the end of the study period in:(Scores of Depression, Anger and Physical domains of DRSP)
- Change from baseline to the end of the study period in:(Scores of subjective self-assessment on hair quality)
- Change from baseline to the end of the study period in:(Scores of Global Acne Grading system for acne)
- Change from baseline to the end of the study period in:(Menstrual distress questionnaire (MDQ))
- Change from baseline to the end of the study period in:(Perceived Stress Scale (PSS-10))
- Change from baseline to the end of the study period in: Female Sexual Function Index (FSFI)(Menstrual cycles 3, 4, 5 & 6)
- Change from baseline to the end of the study period in:(Anthropometric measurements (body weight, waist & hip circumferences))
- Change from baseline to the end of the study period in:(Serum FSH, LH, AMH, SHBG, & total testosterone)
- Change from baseline to the end of the study period in:(Salivary Cortisol)
- Change from baseline to the end of the study period in:(Serum HOMA-IR & HbA1c)
- Change from baseline to the end of the study period in:(Ovarian ultrasound scan (total no. of follicles & Antral Follicle Count of dominant ovary))
研究者
Dr Annavarapu Tirupathi Rao
CLS Pvt Ltd
研究点 (3)
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