Independent and Additive Effects Of Micronutrients With Metformin In Patients With PCOS

NCT05653895 | Completed DMC

• 1 other identifier: KhyberMU
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators aim to conduct a double blind randomized clinical trial to study the independent and additive effects of micronutrients (Resveratrol, Acetyl-L Carnitine, L Arginine and COQ10 ) with Metformin in patients with PCOS .Women diagnosed with PCOS according to National Institute of Health( NIH) 2012 extension of European Society of Human Reproduction and Embryology /American Society of Reproductive Medicine ESHRE /ASRM 2003 criteria will be included according to a specific phenotype including Hyperandrogenism, Ovulatory dysfunction and Polycystic Ovarian Morphology. The investigators propose that by using combination therapy with micro supplements like Resveratrol, Acetyl-L Carnitine, L Arginine and COQ10 will produce greater improvement better than or at least comparable to Metformin in metabolic and endocrine profile of patients with PCOS.

Conditions

PCOS

Outcome Measures

Primary Outcomes (4)

• Insulin Resistance

  PCOS associated insulin resistance and hyperinsulinemia by HOMA-IR

  6 months

• Menstural Irregularities

  Oligo/Anovulation, Questionnaire based history taking of each participant

  6 months

• Anti mullerian Hormone

  Measurement of Anti mullerian hormone by ELISA

  6 months

• Dehydroepiandrosterone

  Measurement of Dehydroepiandrosterone using ELISA

  6 months

Secondary Outcomes (6)

• Antioxidant Assays

  6 months

• Anti oxidant Assays

  6 months

• Mental health questionnaire

  6 months

• Molecular characterisation

  6 months

• perceived stress response (PSS-14) questionnaire

  6 months

Study Arms (4)

Arm 1

ACTIVE COMPARATOR

Resveratrol (2 gm daily) 50 patients with PCOS will receive Resveratrol 1000mg BD daily

Dietary Supplement: Resveratrol

Arm 2

ACTIVE COMPARATOR

Metformin (1000mg daily),Resveratrol(2 gm daily) 50 patients with PCOS will receive Metformin 500mg,Resveratrol 1000 mg BD daily

Dietary Supplement: Resveratrol; Drug: Metformin

Arm 3

ACTIVE COMPARATOR

L-Arginine(3 gm daily), Acetyl L-Carnitine (3 gm daily),CoQ10(200 mg daily) 50 patients with PCOS will receive L Arginine 1500mg,Acetyl L Carnitine 1500mg ,COQ10 100mg BD daily respectively

Combination Product: Acetyl-L-Carnitin, L Arginine, Co-Q10

Arm 4

ACTIVE COMPARATOR

L-Arginine(3 gm daily), Acetyl L-Carnitine (3 gm daily),CoQ10(200 mg daily),Metformin (1000mg daily) 50 patients with PCOS will receive L Arginine 1500mg,Acetyl L Carnitine 1500mg,COQ10 100mg BD daily respectively

Drug: Metformin; Combination Product: Acetyl-L-Carnitin, L Arginine, Co-Q10

Interventions

Resveratrol DIETARY_SUPPLEMENT

Resveratrol

Arm 1; Arm 2

Metformin DRUG

Metformin

Arm 2; Arm 4

Acetyl-L-Carnitin, L Arginine, Co-Q10 COMBINATION_PRODUCT

Treatment of PCOS with combination of Acetyl-L-Carnitin, L Arginine, Co-Q10

Arm 3; Arm 4

Eligibility Criteria

• Age: 16 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• PCOS women aged 16 -45 years.Diagnosis of PCOS will be made according to NIH 2012 extension of ESHRE/ASRM 2003 criteria Identification of specific phenotype will be included
• HA+OD+PCOM (Hyperandrogenism, Ovulatory dysfunctions, Polycystic ovarian morphology)
• HA+OD
• HA+PCOM
• PCOM+OD

You may not qualify if:

• Women with hyperprolactenemia
• Diabetes Mellitus
• Cushing syndrome
• Androgen secreting tumours
• Non classical congenital adrenal hyperplasia
• History of seizures
• Patients on anti coagulants, anti platelets ,isoproterenol ,antidepressants, potassium sparing diuretics
• Pregnancy or use of contraceptives
• Patients with thyroid disease
• Patients on hormonal therapy -

Sponsors & Collaborators

• Khyber Medical University Peshawar: lead

Study Sites (1)

Bacha Khan Medical Complex Swabi

Swabi, Khyber Pukhtunkhwa, 23340, Pakistan

Location

Related Publications (24)

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  PMID: 41026176 DERIVED

MeSH Terms

Interventions

Resveratrol; Metformin; Arginine; Ubiquinone

Intervention Hierarchy (Ancestors)

Stilbestrols; Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polyphenols; Phenols; Biguanides; Guanidines; Amidines; Amino Acids, Basic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Diamino; Amino Acids, Essential; Benzoquinones; Quinones; Coenzymes; Enzymes and Coenzymes

Study Officials

• Mohsin Shah, PHD

  Department of Physiology ,Khyber Medical University ,Peshawar, Pakistan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Triple (Participant ,Care provider ,Outcomes Assessor)
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Treatment of PCOS with Metformin vs Combination therapy

Study Record Dates

• First Submitted: March 1, 2022
• First Posted: December 16, 2022
• Study Start: December 7, 2022
• Primary Completion: December 30, 2023
• Study Completion: February 7, 2024
• Last Updated: February 23, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)