None listed
Conditions
Interventions
Intervention1: CL25216 - 250 mg: One capsule a day after breakfast for 84 days.
Control Intervention1: Placebo: One capsule a day after breakfast for 84 days.
Sponsors
Apex CPG LLC
Laila Nutra Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Healthy females aged between 25-40 years with a Body Mass Index (BMI) of approximately 25 to 29 kg per meter square. 2. Healthy women with primary dysmenorrhea Grade 2 measured using Verbal Multi-dimensional scoring system VMSS, at least for 1 day in 50 percent of menstrual cycles and maximum pain intensity score greater than or equal to 4 on a 10 cm VAS for at least 3 menstrual cycles before participating in the study. 3. Subjects with regular menstrual cycles that typically occur between every 21-35 days, menstrual period 3-7 days in last 6 months. 4.Subjects with normal pelvic TVS and breast mammogram. 5.Subjects without any chronic diseases having symptoms such as burning, itching, abnormal vaginal discharge. 6.Subjects willing to provide their age of menarche and regularity in menstrual cycle. 7.Subjects without any clinical history of gynaecological disorders or ovarian pathology, pelvic pathology like pelvic inflammatory disease, tumor and fibroma or without any history of pelvic surgery screened using pelvic transvaginal sonography 8.Subjects with normal thyroid profile 9.Subjects willing not to use any analgesics 24 hrs. prior screening and throughout the study. 10.Females of childbearing potential who are sexually active must agree to use adequate non-hormonal contraception during the study. 11.Normal vital signs, including 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. 12.Subject understands the study procedures and provides signed informed consent to participate in the study.
Exclusion criteria
Exclusion criteria: 1.Subjects with irregular menstrual cycle, shorter than 21 and longer than 35 days affecting the treatment and efficacy judgment. 2.Subjects with secondary dysmenorrhea menstrual pain associated with conditions such as endometriosis, pelvic inflammatory disease, leiomyomas, Mullerian anomalies, and adenomyosis and interstitial cystitis. 3.Subjects who are on hormonal contraceptive pills or intrauterine contraceptive devices in the past 3 months. 4.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. 5.Subjects with a high blood pressure systolic blood pressure greater than or equal to 140 mmHg or diastolic blood pressure greater than or equal to 90 mmHg and Fasting blood glucose level greater than 125 mg/dl at screening. 6.Subjects who had any hormonal therapy or any other herbal products in the past 3 months. 7.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. 8.Active gall bladder disease, gynaecological or breast surgery in the last 6 months. 9.Subjects underwent hysterectomy or bilateral oophorectomy. 10.History of breast, endometrial, other gynaecological cancer at any time or other cancer within the last 5 years. 11.Smokers or tobacco users. 12.Alcohol intake greater than 2 standard drinks per day, or recreational drugs such as cocaine, methamphetamine, marijuana, etc. or psychiatric drug users. 13.Pregnant and lactating mothers. 14.History of hypersensitivity reactions attributed to investigational product IP or its components or related products. 15.History of positive hepatitis screening including Hepatitis B surface antigen or Hepatitis C virus HCV antibodies or subjects with human immunodeficiency virus HIV and /or syphilis. 16.History of clinically significant illness or any other medical disorder that may interfere with subject treatment, assessment or compliance with the protocol. 17.Any condition that in opinion of the Investigator, does not justify the subjects participation in the study. 18.Subjects with a systemic disease including tuberculosis, leucosis, collagenosis, multiple sclerosis or other autoimmune diseases. 19.Subject consumes significant amounts of soya products in the diet or any products containing red clover, black cohosh, omega 3 or omega 6 fatty acids or any other Ayush or homeopathic preparations that can interfere with the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline to the end of the study period in: Menstrual symptom Questionnaire (MSQ)Timepoint: Baseline (Day 1), Follow up visits - Day 28, 56 & Final visit (Day 84). | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline to the end of the study period in: Pain duration (No. of days)Timepoint: Baseline (Day 1), Follow up visits - Day 28, 56 & Final visit (Day 84).;Change from baseline to the end of the study period in: Female sexual function index (FSFI)Timepoint: Baseline (Day 1), Follow up visits - Day 28, 56 & Final visit (Day 84).;Change from baseline to the end of the study period in: Resting Metabolic Rate (RMR)Timepoint: Baseline (Day 1) & Final visit (Day 84).;Change from baseline to the end of the study period in: Body weight and anthropometric measures (BMI, WC and HC)Timepoint: Baseline (Day 1) & Final visit (Day 84).;Change from baseline to the end of the study period in: Short form (SF-36) quality of lifeTimepoint: Baseline (Day 1), Follow up visits - Day 28, 56 & Final visit (Day 84).;Change from baseline to the end of the study period in: Scores of subjective self-assessments on hair qualityTimepoint: Baseline (Day 1), Follow up visits - Day 28, 56 & Final visit (Day 84).;Change from baseline to the end of the study period in: Skin wrinkle assessmentTimepoint: Baseline (Day 1), Follow up visits - Day 28, 56 & Final visit (Day 84).;Change from baseline to the end of the study period in: Subject s self-assessment of skin QuestionnaireTimepoint: Baseline (Day 1), Follow up visits - Day 28, 56 & Final visit (Day 84).;Change from baseline to the end of the study period in: Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)Timepoint: Baseline (Day 1) & Final visit (Day 84).;Change from baseline to the end of the study period in: Serum levels of Free and Total Testosterone, Estradiol, LH, FSH, LH:FSH, Anti-Mullerian hormone, TNF-alpha, IL-6, and GLP-1.Timepoint: Baseline (Day 1) & Final visit (Day 84). | — |
Countries
India
Contacts
Public ContactMr Prason Kumar J
Laila Nutra Private Limited
Outcome results
None listed