Menstrual DiscomfortNCT06760988
Efficacy of CL22205 to Improve Menstrual Discomfort and Quality of Life
A study testing CL22205 in people with Menstrual Discomfort, run by Eetho Brands, Inc.
Trial summary
The purpose of this study is to evaluate the efficacy of CL22205 to improve menstrual discomfort and quality of life in oligomenorrheic female subjects. Read more about this study
- Who is it for?
- Ages 25 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menstrual Discomfort
- What is being tested?
- CL22205
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 24 Feb 2025to 10 Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy of CL22205 to Improve Menstrual Discomfort and Quality of Life
The purpose of this study is to evaluate the efficacy of CL22205 to improve menstrual discomfort and quality of life in oligomenorrheic female subjects.
Read the 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.
- Conditions
- Menstrual Discomfort
- Being tested
- CL22205, Placebo
- Keywords
- Quality of life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CL22205Dietary supplement
Experimental Dose: 200 mg, Mode: Oral, once daily after breakfast Duration: 135 days
PlaceboOther
Mode: Oral, once daily after breakfast Duration: 135 days
| Study group | Role | What they receive |
|---|---|---|
| CL22205 | Experimental | 200 mg - One capsule a day after breakfast for 135 days Receives: Dietary Supplement: CL22205 |
| Placebo | Placebo comparator | One Capsule a day after breakfast for 135 days Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1, Day 45 (±10 days), Day 90 (±10 days), Day 135 (±10 days)
Secondary outcomes (9)
Change from baseline to the end of the study period in: Ovarian Follicular analysis
using USG
Measured: Day 1 & Day 135 (±10 days)
Change from baseline to the end of the study period in: Serum levels of FSH and LH
Biomarkers
Measured: 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.))
Measured: 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).
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: Day 1, Day 45 (±10 days), Day 90 (±10 days), Day 135 (±10 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2025
- Study start24 Feb 2025 (estimated)
- Primary completion5 Oct 2025 (estimated)
- Study completion10 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Menstrual DiscomfortStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eetho Brands, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr. Varuni B.G, Principal investigator, Consultant
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06760988
- Sponsor's protocol ID
- EB/MH/CL22205/24
- Status last verified
- Mar 2025
- First submitted
- 24 Dec 2024
- Last updated
- 7 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy of CL22205 to Improve Menstrual Discomfort and Quality of Life
- ClinicalTrials.gov ID
- NCT06760988
- Acronym / sponsor ID
- EB/MH/CL22205/24
- Conditions
- Menstrual Discomfort
- Keywords
- Quality of life
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Eetho Brands, IncIndustry (pharma, biotech, devices)
- Study start
- 24 Feb 2025 (estimated)
- Primary completion
- 5 Oct 2025 (estimated)
- Study completion
- 10 Jan 2026 (estimated)
- First posted
- 7 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CL22205 | Experimental | Dietary Supplement: CL22205200 mg - One capsule a day after breakfast for 135 days |
| Placebo | Placebo comparator | Other: PlaceboOne Capsule a day after breakfast for 135 days |
Who may qualify
- Ages
- 25 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CL22205Experimental Dose: 200 mg, Mode: Oral, once daily after breakfast Duration: 135 days | Dietary supplement | CL22205 |
| PlaceboMode: Oral, once daily after breakfast Duration: 135 days | Other | Placebo |
Primary outcome
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)
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.
9 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dr. Varuni B.G principal investigator
Consultant
Questions about this trial
What is this clinical trial studying?
A study testing CL22205 in people with Menstrual Discomfort, run by Eetho Brands, Inc.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vasu Goyal (2125550199, eethos.c@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2025.