Effect of Metformin and Combination of Olive Oil Plus Nutritional Supplements on Inflammatory Markers IL-6 and IL-8 in PCOS.
Key facts
- Who runs it
- Khyber Medical University Peshawar
- Where
- Pakistan1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Completed
- Phase
- Phase 2
- People taking part
- 88 people enrolled
- Started
- 1 Jul 2023
- Ended
- 1 Apr 2024
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- OLIVE OIL 5ML/5MG (BD) NUTRITIONAL SACHET 2100MG (BD)
- Metformin (1000 mg Twice a day)
- Record updated
- 19 September 2024
Who can take part
- Age
- 18 years to 34 years
- Sex
- Women only
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 8 criteriaShow less
Who can take part
- Women diagnosed according to Rotterdam criteria (2 out of 3 should be present); Hyperandrogenism; Polycystic ovaries; Menstrual irregularities
- Age 18-34 years
Who cannot take part
- Previous history of Cushing's syndrome
- Women using other medications simultaneously which may affect hormonal changes
- Previous history of ovarian surgery
- Thyroid diseases
- Autoimmune diseases; •
- Congenital adrenal hyperplasia
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
The investigators aim is to conduct randomized clinical trial, to determine the effects of metformin and combination of olive oil plus nutritional supplements on inflammatory markers IL-8 and IL6 in polycystic ovarian syndrome (PCOS). Women diagnosed with PCOS using "Rotterdam diagnostic criteria" according to which two out of three characters must be their in women of PCOS. The investigators propose that PCOS women have increase levels of IL-6 ,IL-8 and this therapy would have beneficial effects and is able to reduce their increase interleukins levels .
The 2 groups in the trial
- Combination Therapy GroupExisting treatment, for comparison
ARM# 1 OLIVE OIL 5ML/5MG (BD) NUTRITIONAL SACHET 2100MG (BD)
Treatment: OLIVE OIL 5ML/5MG (BD) NUTRITIONAL SACHET 2100MG (BD)
- Standard Therapy GroupOther group
ARM # 2 METFORMIN 1000MG (BD)
Treatment: Metformin (1000 mg Twice a day)
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Record updated
- 19 September 2024