Efficacy of CL25216 on Hormonal Balance and Menstrual Health in Women With Primary Dysmenorrhea.
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age25-40
SponsorApexCPG LLC
About this 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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
CL25216
Dietary supplementCL25216: 250mg, One capsule a day after breakfast for 84 days.
Placebo
Other interventionOne capsule a day after breakfast for 84 days.
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: CL25216Experimental treatment 1 intervention
Group B: PlaceboOther 1 intervention
Trial outcomes
Primary outcomes
1
Menstrual symptom Questionnaire
The MSQ is a validated instrument designed to provide a concise assessment of menstrual pain symptoms. It consists of 25 items, each measuring the severity of climacteric symptoms on a scale from 1 (never) to 5 (always), in between 2 emans rarely, 3 means sometimes and 4 represents. The total score ranges from 29 to 125, with higher scores reflecting more severe menstrual pain symptoms.
Time frame
At day 1, 28, 56, and 84Secondary outcomes
1
Pain duration
No. of days subject experiencing the pain during menstrual cycle will be captured. As the no. of days increasing, QoL decreases.
Time frame
At day 1, 28, 56, and 842
Female sexual function index
The FSFI was developed as a brief, easy-to-administer, self-report tool for assessing key dimensions or domains of sexual function and quality of life in various populations of women. Female Sexual Function Index (FSFI), a widely used tool with six domains (Arousal, Desire, Orgasm, Lubrication, Satisfaction, and Pain). The total FSFI score ranges from minimum score of 2 and maximum score of 36. Greater Scores indicates better sexual function
Time frame
At day 1, 28, 56, and 843
Resting Metabolic Rate (RMR)
RMR reflects the caloric expenditure necessary for life, without accounting for physical activity or digestion, measured by using metabolic analyzer. Increase in RMR is a sign of improved metabolism
Time frame
At day 1, 28, 56, and 844
Bodyweight
The subject's body weight is measured using a digital weighing scale. An improvement is indicated when the body weight falls within the normal range based on the subject's demographic characteristics.
Time frame
At day 1, 28, 56, and 84Sponsors and contacts
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Source ClinicalTrials.gov
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