Effect of Coenzyme Q10 Administration on Polycystic Ovary Syndrome

NCT ID: NCT06659406

Last Updated: 2024-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-01

Study Completion Date

2025-12-31

Brief Summary

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The goal of this clinical trial is to determine the effects of coenzyme Q10 supplementation on oxidative stress, inflammation and hyperandrogenism in women with polycystic ovary syndrome. The main questions it aims to answer are:

Does Coenzyme Q10 alter oxidative stress, inflammation and hyperandrogenism in women with Polycystic ovary syndrome.

Participants will take Coenzyme Q10 200mg, once daily for a period of 3 months. The participants will be reassessed after 12 weeks by measuring Malondialdehyde MDA, C-reactive protein CRP, Sex hormone binding globulin SHBG.

Detailed Description

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Conditions

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Polycystic Ovarian Syndrome (PCOS)

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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CoQ-10 supplementation

The experimental arm will consist of fertile females diagnosed with polycystic ovary syndrome aged between 18 to 50 years. Patients with diabetes mellitus, thyroid dysfunction, cardiovascular diseases, impairment of hepatic and renal function, autoimmune and Inflammatory disorders will be excluded.

Group Type EXPERIMENTAL

Coenzyme Q10

Intervention Type DIETARY_SUPPLEMENT

Coenzyme Q10 will be given once daily, 200mg for the period of 3 months

Interventions

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Coenzyme Q10

Coenzyme Q10 will be given once daily, 200mg for the period of 3 months

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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ubiquinone

Eligibility Criteria

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Inclusion Criteria

* Married Patients that presented with anovulatory infertility due to PCOS.
* Unmarried Patients that presented with symptoms due to PCOS
* All patients should fulfill Rotterdam criteria for PCOS

Exclusion Criteria

* Male factor infertility ( oligospermia or aspermia)
* Tubal factor infertility (abnormal hysterosalpingography)
* Diabetes mellitus, thyroid dysfunction, cardiovascular diseases, impairment of hepatic and renal function
* Autoimmune and Inflammatory disorders
* Abnormal serum prolactin level
* Smokers
* Alcoholic beverage use
* Use of anti diabetic, anti-obesity drugs, insulin or vitamin and mineral supplements
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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College of Physicians and Surgeons Pakistan

OTHER

Sponsor Role collaborator

University of Faisalabad

OTHER

Sponsor Role lead

Responsible Party

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hira zahid

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sana Akram, MBBS, FCPS

Role: STUDY_DIRECTOR

University of Faisalabad

Locations

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Madinah Teaching Hospital

Faisalabad, Punjab Province, Pakistan

Site Status

Countries

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Pakistan

Central Contacts

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hira zahid, MBBS, M.Phil.

Role: CONTACT

+923237624565

Sana Akram, MBBS, FCPS

Role: CONTACT

+923334577182

Facility Contacts

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Dr Sadia Ijaz, FCPS Hematology

Role: primary

+923037869990

Dr Sana Akram, FCPS PHYSIOLOGY

Role: backup

+923334577182

Hira Zahid, MBBS, Masters in Physiology

Role: backup

References

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Hu X, Wang W, Su X, Peng H, Tan Z, Li Y, Huang Y. Comparison of nutritional supplements in improving glycolipid metabolism and endocrine function in polycystic ovary syndrome: a systematic review and network meta-analysis. PeerJ. 2023 Nov 13;11:e16410. doi: 10.7717/peerj.16410. eCollection 2023.

Reference Type BACKGROUND
PMID: 38025704 (View on PubMed)

Related Links

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https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7668517/

Efficacy of coenzyme Q10 supplementation on glucose metabolism, lipid profiles, and biomarkers of inflammation in women with polycystic ovary syndrome

Other Identifiers

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Tuf/IRB/275/24

Identifier Type: -

Identifier Source: org_study_id

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