Efficacy of CL22205 to Improve Menstrual Discomfort and Quality of Life

Official title

A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy of CL22205 to Improve Menstrual Discomfort and Quality of Life

Overview

The purpose of this study is to evaluate the efficacy of CL22205 to improve menstrual discomfort and quality of life in oligomenorrheic female subjects.

Detailed description

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 composition's 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.

Interventions

• Dietary supplement CL22205
  Experimental Dose: 200 mg, Mode: Oral, once daily after breakfast Duration: 135 days
• Other Placebo
  Mode: Oral, once daily after breakfast Duration: 135 days

Primary outcome measures

• Change from baseline to the end of the study period in: The Menstrual Symptoms Questionnaire (MSQ) scores [Time frame: Day 1, Day 45 (±10 days), Day 90 (±10 days), Day 135 (±10 days)]

Secondary outcome measures (9)

• Change from baseline to the end of the study period in: Ovarian Follicular analysis [Time frame: Day 1 & Day 135 (±10 days)]
• Change from baseline to the end of the study period in: Serum levels of FSH and LH [Time frame: Day 1 & Day 135 (±10 days)]
• Change from baseline to the end of the study period in: Scores of subjective self-assessment on hair quality [Time frame: Day 1, Day 45 (±10 days), Day 90 (±10 days), Day 135 (±10 days)]
• Change from baseline to the end of the study period in: Scores of Global Acne Grading system for acne [Time frame: Day 1, Day 45 (±10 days), Day 90 (±10 days), Day 135 (±10 days)]
• Change from baseline to the end of the study period in: Menstrual distress questionnaire (MDQ) [Time frame: Day 1, Day 45 (±10 days), Day 90 (±10 days), Day 135 (±10 days)]
• Change from baseline to the end of the study period in: Regularity in menstrual cycles (duration between two menstrual bleedings) [Time frame: Day 1, Day 45 (±10 days), Day 90 (±10 days), Day 135 (±10 days)]
• Change from baseline to the end of the study period in: Serum levels of AMH, total testosterone and Progesterone [Time frame: Day 1 & Day 135 (±10 days)]
• Change from baseline to the end of the study period in: Serum levels of SHBG, 17β Estradiol (E2), and Prostaglandin F2 alpha (PGF2 alpha). [Time frame: Day 1 & Day 135 (±10 days)]
• Change from baseline to the end of the study period in: Female Sexual Function Index (FSFI) [Time frame: Day 1, Day 45 (±10 days), Day 90 (±10 days), Day 135 (±10 days)]

Eligibility criteria

Inclusion criteria

• 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.
• Subjects with maximum pain intensity ≥40 mm on a 100 mm VAS for at least 2 menstrual cycles before participating in the study.
• Subjects with normal thyroid profile.
• Subjects who are non-smokers and non-alcohol user.
• Subject understands the study procedures and provides signed informed consent to participate in 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, 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

• History of any gynaecological disorders which effects the study indication.
• 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.
• Subjects who had any hormonal therapy, metformin 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 (except the usual drugs of the subjects).
• Active gall bladder disease, gynaecological or breast surgery in the last 6 months.
• Subjects underwent hysterectomy.
• History of breast, endometrial, other gynaecological cancer at any time or other cancer within the last 5 years.
• Pregnant and lactating mothers.
• History of hypersensitivity reactions attributed to investigational product (IP) or its components or related products.
• 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.
• History of clinically significant illness or any other medical disorder that may interfere with subject treatment, assessment or compliance with the protocol.
• Participated in a clinical study with an investigational drug or biologic within the last 60 days.
• Any condition that in opinion of the investigator, does not justify the subjects' participation in the study.
• Subjects who are being treated for liver cancer or cirrhosis, chronic renal failure, congestive heart failure.
• Subjects with a systemic disease including tuberculosis, leucosis, collagenosis, multiple sclerosis or other autoimmune diseases.
• Subjects with a high blood pressure at screening (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥ 90 mmHg).
• Consumption of recreational drugs (such as cocaine, methamphetamine, marijuana, etc.) or psychiatric drug users.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Health services research

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06760988 · EB/MH/CL22205/24

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗