Efficacy of CL25216 on Hormonal Balance and Menstrual Health in Women With Primary Dysmenorrhea.

The Effect of CL25216 on Hormonal Balance and Menstrual Health in Women With Primary Dysmenorrhea: A Randomized, Double-blind, Placebo Controlled Clinical Trial

This study is to evaluate the effects of CL25216 on hormonal balance and menstrual health in women with primary dysmenorrhea. Enrolled subjects will receive either CL25216 - 250 mg/day or placebo.

The purpose of this study is to evaluate the effect of CL25216 on hormonal balance and menstrual health in women with primary dysmenorrhea. A total of 80 female aged between 25-40 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 CL25216 - 250 mg or placebo arms at 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 safety and tolerability. The safety assessment of the CL25216 will also include routine laboratory investigations on blood, urine and clinical chemistry at Screening visit and the final visit of the intervention.

Inclusion Criteria:

• Healthy females aged between 25-40 years with a Body Mass Index (BMI) of approximately 25 to 29 kg/m2.
• Healthy women with primary dysmenorrhea Grade 2 (measured using Verbal Multi-dimensional scoring system (VMSS)) at least for 1 day in 50 % of menstrual cycles and maximum pain intensity score ≥4 on a 10 cm VAS for at least 3 menstrual cycles before participating in the study.
• Subjects with regular menstrual cycles that typically occur between every 21-35 days (menstrual period 3-7 days) in last 6 months.
• Subjects with normal pelvic TVS and breast mammogram.
• Subjects without any chronic diseases having symptoms such as burning, itching, abnormal vaginal discharge.
• Subjects willing to provide their age of menarche and regularity in menstrual cycle.
• Subjects without any clinical history of Gynaecological disorders or ovarian pathology, pelvic pathology like pelvic inflammatory disease, tumour and fibroma or without any history of pelvic surgery (screened using pelvic transvaginal sonography (TVS))
• Subjects with normal thyroid profile
• Subjects willing not to use any analgesics 24 hrs. prior screening and throughout the study.
• Females of childbearing potential who are sexually active must agree to use adequate non-hormonal contraception during the study.
• 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.
• Subject understands the study procedures and provides signed informed consent to participate in the study

Exclusion Criteria:

• Subjects with irregular menstrual cycle (shorter than 21 and longer than 35 days) affecting the treatment and efficacy judgment.
• Subjects with secondary dysmenorrhea (menstrual pain associated with conditions such as endometriosis, pelvic inflammatory disease, leiomyomas, Mullerian anomalies, and adenomyosis and interstitial cystitis).
• Subjects who are on related medications such as NSAIDs or hormonal contraceptive pills or intrauterine contraceptive devices in the past 3 months.
• 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.
• Subjects with a high blood pressure (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥ 90 mmHg) and Fasting blood glucose level >125 mg/dl at screening.
• Subjects who had any hormonal therapy or any other herbal products in the past 3 months.
• Hypothyroidism, hyperthyroidism, hyperprolactinemia, Cushing's 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.
• Active gall bladder disease, gynaecological or breast surgery in the last 6 months.
• Subjects underwent hysterectomy or bilateral oophorectomy.
• History of breast, endometrial, other gynaecological cancer at any time or other cancer within the last 5 years.
• Smokers or tobacco users.
• Alcohol intake (>2 standard drinks per day), or recreational drugs (such as cocaine, methamphetamine, marijuana, etc.) or psychiatric drug users.
• Pregnant and lactating mothers.
• History of hypersensitivity reactions attributed to investigational product (IP) or its components or related products.
• 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.
• History of clinically significant illness or any other medical disorder that may interfere with subject treatment, assessment or compliance with the protocol.
• Any condition that in opinion of the Investigator, does not justify the subjects' participation in the study.
• Subjects with a systemic disease including tuberculosis, leucosis, collagenosis, multiple sclerosis or other autoimmune diseases.
• 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