Efficacy of CL22205 to Improve Menstrual Discomfort and Quality of Life
ConditionMenstrual Discomfort
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age25-35
SponsorEetho Brands, Inc
About this trial
The purpose of this study is to evaluate the efficacy of CL22205 to improve menstrual discomfort and quality of life in oligomenorrheic female subjects.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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).
Trial design
Design model
Parallel
Treatments tested in this trial
CL22205
Dietary supplementExperimental Dose: 200 mg, Mode: Oral, once daily after breakfast Duration: 135 days
Placebo
Other interventionMode: Oral, once daily after breakfast Duration: 135 days
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: CL22205Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change from baseline to the end of the study period in: The Menstrual Symptoms Questionnaire (MSQ) scores
The Menstrual Symptom Questionnaire (MSQ) is a tool used to assess the severity and type of menstrual symptoms experienced by individuals. This questionnaire includes 24 items, where subjects will be instructed to indicate the degree to which they experience the symptom by selecting one of the five responses \[Never (N), Rarely (R), Sometimes (S), Often (O). and Always (A). The first 24 items are characteristics of either spasmodic or congestive dysmenorrhea. The type of dysmenorrhea indicates the order of scoring for each item. Items designated as S (Spasmodic), score as indicated by numbers 1-5. Items designated as C (Congestive), reverse scoring. For the twenty-fifth item subjects will be instructed to read the descriptions of two types of menstrual discomfort and select the type that most closely fits their experience. The subjects with spasmodic dysmenorrhea will receive higher total scores while those with congestive dysmenorrhea will receive lower total scores.
Time frame
Day 1, Day 45 (±10 days), Day 90 (±10 days), Day 135 (±10 days)Secondary outcomes
1
Change from baseline to the end of the study period in: Ovarian Follicular analysis
using USG
Time frame
Day 1 & Day 135 (±10 days)2
Change from baseline to the end of the study period in: Serum levels of FSH and LH
Biomarkers
Time frame
Day 1 & Day 135 (±10 days)3
Change from baseline to the end of the study period in: Scores of subjective self-assessment on hair quality
This is a subjective measurement of hair quality by considering the hair fall rate, assessed based on the number of hair strands shed per day, with scores ranging from 1 to 5 (score 1: \>100strands, score 2: 50-100 strands, score 3: 30-50strands, score 4: 10-30 strands and Score 5: Less than 10 (indicating best possible condition). The hair texture assessment, ranges from 1 to 5 (score 1: Rough and frizzy (worst possible condition) to 5: Very soft (best possible condition.)) The hair volume ranges from 1 to 5, (Score 1: Very low volume (worst possible condition) to Score 5: Excellent volume (best possible condition.)) The hair fall grading ranges from 0 to 5, (Score 0: No itching (best possible condition); Score 5: Very severe itching.))
Time frame
Day 1, Day 45 (±10 days), Day 90 (±10 days), Day 135 (±10 days)4
Change from baseline to the end of the study period in: Scores of Global Acne Grading system for acne
The Global Acne Grading System (GAGS) is a widely used method to assess the severity of acne vulgaris. This system grades the acne present on face, chest, and upper back by considering 7 locations viz; the forehead, right cheek, left cheek, nose, chin, and chest and upper back combined. Each acne lesion will be graded as no lesions (grade 0) a comedone (grade 1), papule (grade 2), pustule (grade 3), or nodule (grade 4).The local score for each anatomic area was determined by multiplying the grade of the most severe lesion with an area specific factor (1 to 3), and then summation of all 7 local scores represents the total acne severity score. Acne severity was graded as none (total score, 0 points), mild (total score, 1-18 points), moderate (total score, 19-30 points), severe (total score, 31-38 points), and very severe (total score \>38 points).
Time frame
Day 1, Day 45 (±10 days), Day 90 (±10 days), Day 135 (±10 days)Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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