Efficacy of CL22205 to Improve Menstrual Discomfort and Quality of Life

NCT06760988 | Not Yet Recruiting

• 1 other identifier: EB/MH/CL22205/24
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Menstrual Discomfort

Keywords

Quality of life

Outcome Measures

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.

  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

  Day 1 & Day 135 (±10 days)

• Change from baseline to the end of the study period in: Serum levels of FSH and LH

  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

  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

  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)

  Day 1, Day 45 (±10 days), Day 90 (±10 days), Day 135 (±10 days)

Study Arms (2)

CL22205

EXPERIMENTAL

200 mg - One capsule a day after breakfast for 135 days

Dietary Supplement: CL22205

Placebo

PLACEBO COMPARATOR

One Capsule a day after breakfast for 135 days

Other: Placebo

Interventions

CL22205 DIETARY_SUPPLEMENT

Experimental Dose: 200 mg, Mode: Oral, once daily after breakfast Duration: 135 days

CL22205

Placebo OTHER

Mode: Oral, once daily after breakfast Duration: 135 days

Placebo

Eligibility Criteria

• Age: 25 Years - 35 Years
• Gender Eligibility Details: Oligomenorrheic females (Menstrual cycle duration between 36-45 days)
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eetho Brands, Inc: lead

Study Officials

• Dr. Varuni B.G

  Consultant

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vasu Goyal

CONTACT

2125550199; eethos.c@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 24, 2024
• First Posted: January 7, 2025
• Study Start: February 24, 2025
• Primary Completion: October 5, 2025
• Study Completion: January 10, 2026
• Last Updated: March 7, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share