NCT07529561

Efficacy of CL25216 on Hormonal Balance and Menstrual Health in Women With Primary Dysmenorrhea.

The Effect of CL25216 on Hormonal Balance and Menstrual Health in Women With Primary Dysmenorrhea: A Randomized, Double-blind, Placebo Controlled Clinical Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: ApexCPG LLC · Industry
• Sex: Female
• Age: 25 Years – 40 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

The purpose of this study is to evaluate the effect of CL25216 on hormonal balance and menstrual health in women with primary dysmenorrhea. A total of 80 female aged between 25-40 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 CL25216 - 250 mg or placebo arms at 1:1 ratio. The subjects will be instructed to take one capsule a day after breakfast for 84 days. Apart from primary and secondary outcomes, the study will also record the vital signs and adverse events to evaluate the herbal composition safety and tolerability. The safety assessment of the CL25216 will also include routine laboratory investigations on blood, urine and clinical chemistry at Screening visit and the final visit of the intervention.

Conditions

• Primary Dysmenorrhea
• Menstural Cramps

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	CL25216	CL25216: 250mg, One capsule a day after breakfast for 84 days.
OTHER	Placebo	One capsule a day after breakfast for 84 days.

Timeline

• Start date: 2026-04-13
• Primary completion: 2026-09-10
• Completion: 2026-09-10
• First posted: 2026-04-14
• Last updated: 2026-04-14

Locations

1 site across 1 country: India