The Effect of Combination Therapy Dlbs 3233 and Clomifen Citrate vs Clomifen Citrate on Homa ir, Maturation Follicle, and Menstrual Cycle in PCOS Cases at Muhammadiyah Asri Medical Center Hospital
Trial Snapshot
- Phase
- Phase 1
- Status
- Recruiting
- Sponsor
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- Change in HOMA-IR
Study Overview
Brief Summary
The effect of combination therapy dlbs 3233 and clomifen citrate vs clomifen citrate on homa ir, maturation follicle, and menstrual cycle in PCOS cases at Muhammadiyah Asri Medical Center Hospital
Detailed Description
to know the effect of combination dlbs 3233 theraphy and clomifen citrat in cases PCOS to control menstrual cycle and weight loss
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- — to 45 Years (Child, Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •married agree to join this research
Exclusion Criteria
- •dis agree to join research
Arms & Interventions
Interprofessional collaboration treatment for PCOS at RS AMC Yogyakarta
to know the effect of interproffessional collaboration in pcos patient. And also to try give the best treatment for pcos patient
The effectiveness Inlacin therapy vs clomiphene citrat to optimize AMH in PCOS
To compare the effectiveness of treatment for women with pcos syndrome between inlacin and clomiphene citrat with knowing the AMH first
Intervention: dlbs 3233 , clomifen citrat (Combination Product)
Outcomes
Primary Outcomes
Change in HOMA-IR
Time Frame: Baseline (Day 3 of menses) to 3 months (Day 3 of menses after treatment)
HOMA-IR will be used to assess insulin resistance. Fasting glucose and fasting insulin will be collected on Day 3 of menses at baseline (pre-treatment) and after 3 months of treatment, and HOMA-IR will be calculated as a single index value.
Change in serum AMH concentration
Time Frame: Baseline (Day 3 of menses) to 3 months (Day 3 of menses after treatment)
Serum anti-mullerian hormone (AMH) will be measured from venous blood collected on Day 3 of menses at baseline (pre-treatment) and after 3 months of treatment to assess ovarian function response.
Secondary Outcomes
- Change in total follicle count on Day 12 ultrasound(Baseline cycle (Day 12) to Month 3 cycle (Day 12))
- Change in number of mature follicles on Day 12 ultrasound(Baseline cycle (Day 12) to Month 3 cycle (Day 12))
- Change in mature follicle diameter on Day 12 ultrasound(Baseline cycle (Day 12) to Month 3 cycle (Day 12))
- Menstrual cycle regularity during the 3-month treatment period(During the 3-month treatment period)