CTRI/2025/01/078999已完成不适用
A randomized, double-blind, placebo-controlled study to evaluate the efficacy of CL22205 to improve menstrual discomfort and quality of life.
Eetho Brands Inc (DBA: Dose)2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2025年1月31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
- 80
- 试验地点
- 2
- 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 CL22205 to improve menstrual discomfort and quality of life in oligomenorrheic female subjects. A total of 80 oligomenorrheic female subjects aged between 25 and 35 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 CL22205 200 mg or placebo arm at 1:1 ratio. The subjects will be instructed to take one capsule a day after breakfast for 135 days. Apart from primary and secondary outcomes, the study will also record the vital signs and adverse events to evaluate the herbal compositions safety and tolerability. The safety assessment of the CL22205 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 35.00 Year(s)（—）
- 性别
- Female
入选标准
- •1.Oligomenorrheic females (Menstrual cycle duration between 36-45 days), aged between 25 and 35 years and with a Body Mass Index (BMI) between 20 to 29.9 kg/m
- •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 patients).
- •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.
- •15.Subjects with a systemic disease including tuberculosis, leucosis, collagenosis, multiple sclerosis or other autoimmune diseases.
- •16.Subjects with a high blood pressure at 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 cycle 1, 2, 3 & 4
The Menstrual Symptoms Questionnaire (MSQ) scores
时间窗: Menstrual cycle 1, 2, 3 & 4
次要结局
- 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:(Female Sexual Function Index (FSFI))
- Change from baseline to the end of the study period in:(Regularity in menstrual cycles (duration between two menstrual bleedings))
- Change from baseline to the end of the study period in: Ovarian Follicular analysis(Menstrual cycle 1 & 4)
- Change from baseline to the end of the study period in:(Serum levels of FSH, LH, AMH, SHBG, total testosterone, 17 beta-Estradiol (E2), Progesterone & Prostaglandin F2 alpha (PGF2 alpha).)
研究者
Dr Varuni B G
Eetho Brands Inc (DBA: Dose)
研究点 (2)
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