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The purpose of this study is to evaluate the efficacy of CL22205 to improve menstrual discomfort and quality of life in oligomenorrheic female subjects.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CL22205 | Experimental | 200 mg - One capsule a day after breakfast for 135 days |
|
| Placebo | Placebo Comparator | One Capsule a day after breakfast for 135 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CL22205 | Dietary Supplement | Experimental Dose: 200 mg, Mode: Oral, once daily after breakfast Duration: 135 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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.](streamdown:incomplete-link) | Day 1, Day 45 (±10 days), Day 90 (±10 days), Day 135 (±10 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline to the end of the study period in: Ovarian Follicular analysis | using USG | Day 1 & Day 135 (±10 days) |
| Change from baseline to the end of the study period in: Serum levels of FSH and LH |
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Inclusion Criteria:
Exclusion Criteria:
Oligomenorrheic females (Menstrual cycle duration between 36-45 days)
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Vasu Goyal | Contact | 2125550199 | eethos.c@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Dr. Varuni B.G | Consultant | Principal Investigator |
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| Placebo | Other | Mode: Oral, once daily after breakfast Duration: 135 days |
|
Biomarkers
| 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 | 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.)) | 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 | 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). | 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) | The Menstrual Discomfort Questionnaire (MDQ) consists of 46 item self-reported inventory used to assess the premenstrual and menstrual symptoms measured at three time points: "Most Recent Flow" (menstrual phase), "Four Days Before" (premenstrual phase), and "Remainder of Cycle" (intermenstrual phase). For each item, respondents rate their experience using a 5-point scale: where 0 means, no experience of symptom, 1: Present, mild 2: Present, moderate 3: Present, strong 4: Present, severe. Respondents select the category that best describes their experience. The 46 items are grouped into 8 domains (Pain, Water Retention, Autonomic Reactions, Negative Affect, Impaired Concentration, Behavior Change, Arousal, and Control). Raw scores for each domain are calculated for the three phases and then converted to T-scores. Higher T-scores indicate greater distress. | 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) | menstural regularity | 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 | Biomarkers | 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). | Biomarkers | Day 1 & Day 135 (±10 days) |
| Change from baseline to the end of the study period in: Female Sexual Function Index (FSFI) | 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. | Day 1, Day 45 (±10 days), Day 90 (±10 days), Day 135 (±10 days) |