NCT06760988

Efficacy of CL22205 to Improve Menstrual Discomfort and Quality of Life

A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy of CL22205 to Improve Menstrual Discomfort and Quality of Life

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Eetho Brands, Inc · Industry
• Sex: Female
• Age: 25 Years – 35 Years
• Healthy volunteers: Accepted

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.

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

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	CL22205	Experimental Dose: 200 mg, Mode: Oral, once daily after breakfast Duration: 135 days
OTHER	Placebo	Mode: Oral, once daily after breakfast Duration: 135 days

Timeline

• Start date: 2025-02-24
• Primary completion: 2025-10-05
• Completion: 2026-01-10
• First posted: 2025-01-07
• Last updated: 2025-03-07