None listed
Conditions
Interventions
Intervention1: CL22209: Dose: 50 mg, Frequency: One capsule a day after breakfast, Route of administration: Oral, Duration: 84 Days
Intervention2: CL22209: Dose: 100 mg, Frequency: One capsule a day a
Sponsors
CLS Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Healthy females aged between 25 and 45 years with a Body Mass Index (BMI) of approximately 20 to 29.9 kg/m2. 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline to the end of the study period in: Total score of PMS using Daily Record of Severity of Problems (DRSP) Timepoint: Menstrual cycles 1, 2, 3, 4, 5 & 6 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline to the end of the study period in: Scores of Depression, Anger and Physical domains of DRSPTimepoint: Menstrual cycles 1,2, 3, 4, 5 & 6 ;Change from baseline to the end of the study period in: Scores of subjective self-assessment on hair qualityTimepoint: Menstrual cycles 3, 4, 5 & 6;Change from baseline to the end of the study period in: Scores of Global Acne Grading system for acneTimepoint: Menstrual cycles 3, 4, 5 & 6;Change from baseline to the end of the study period in: Menstrual distress questionnaire (MDQ)Timepoint: Menstrual cycles 3, 4, 5 & 6;Change from baseline to the end of the study period in: Perceived Stress Scale (PSS-10)Timepoint: Menstrual cycles 3, 4, 5 & 6;Change from baseline to the end of the study period in: Female Sexual Function Index (FSFI)Timepoint: Menstrual cycles 3, 4, 5 & 6;Change from baseline to the end of the study period in: Anthropometric measurements (body weight, waist & hip circumferences)Timepoint: Menstrual cycles 3, 4, 5 & 6;Change from baseline to the end of the study period in: Serum FSH, LH, AMH, SHBG, & total testosteroneTimepoint: Menstrual cycles 3 & 6;Change from baseline to the end of the study period in: Salivary CortisolTimepoint: Menstrual cycles 3 & 6;Change from baseline to the end of the study period in: Serum HOMA-IR & HbA1cTimepoint: Menstrual cycles 3 & 6;Change from baseline to the end of the study period in: Ovarian ultrasound scan (total no. of follicles & Antral Follicle Count of dominant ovary)Timepoint: Menstrual cycles 3 & 6 | — |
Countries
India
Contacts
Public ContactMr Ajjarapu Srinivasu
CLS Pvt Ltd
Outcome results
None listed