None listed
Conditions
Interventions
Intervention1: CL22205: 200 mg - One capsule a day after breakfast for 135 days
Control Intervention1: Placebo: One capsule a day after breakfast for 135 days
Sponsors
Eetho Brands Inc (DBA: Dose)
Eligibility
Inclusion criteria
Inclusion criteria: 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/m2. 2.Subjects with maximum pain intensity greater than or equal to 40 mm on a 100 mm VAS for at least 2 menstrual cycles before participating in the study. 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 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. 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 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: The Menstrual Symptoms Questionnaire (MSQ) scores Timepoint: Menstrual cycle 1, 2, 3 & 4 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline to the end of the study period in: Scores of Global Acne Grading System for acneTimepoint: Menstrual cycle 1, 2, 3 & 4;Change from baseline to the end of the study period in: Menstrual distress questionnaire (MDQ)Timepoint: Menstrual cycle 1, 2, 3 & 4;Change from baseline to the end of the study period in: Female Sexual Function Index (FSFI)Timepoint: Menstrual cycle 1, 2, 3 & 4;Change from baseline to the end of the study period in: Regularity in menstrual cycles (duration between two menstrual bleedings)Timepoint: Menstrual cycle 1, 2, 3 & 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).Timepoint: Menstrual cycle 1 & 4;Change from baseline to the end of the study period in: Ovarian Follicular analysisTimepoint: Menstrual cycle 1 & 4;Change from baseline to the end of the study period in: Scores of subjective self-assessment on hair qualityTimepoint: Menstrual cycle 1, 2, 3 & 4 | — |
Countries
India
Contacts
Public ContactShilpa K
Eetho Brands Inc (DBA: Dose)
Outcome results
None listed