Effect of Theronomic Ova-All Care on Biomarkers of Ovarian Health in Adult Female With Polycystic Ovarian Syndrome

Wellizen Australia

Status and phase: Not yet enrolling; Phase 2

Conditions: Polycystic Ovarian Syndrome (PCOS)

Treatments: Dietary Supplement: Theronomic Ova-All Care

Study type: Interventional

Funder types: Industry

Identifiers

NCT06963840

WEL202501

Details and patient eligibility

About

Theronomic Ova-All Care is a tribiotic health product aimed at improving ovarian health in people with polycystic ovarian syndrome (PCOS). In this study, a total of 16 participants with PCOS diagnosed by a gynaecologist will be invited to take Ova-All Care, two capsule once a day, for 12 weeks. Biomarkers of ovarian health will be measured at baseline, four weeks after the start of the intervention, and at the end of the intervention.

Enrollment: 16 estimated patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria

1. Women aged 18-40 years
2. Previous diagnosis of PCOS by a gynaecologist
3. Able to take body temperature every day for 12 weeks
4. Able to attend the testing centre every 4 weeks
5. Able to complete online questionnaires

Exclusion criteria

1. Pregnancy, lactation;
2. Uterine amenorrhea (such as intrauterine adhesions)
3. Thyroid disease or hyperprolactinemia
4. Liver and kidney dysfunction, autoimmune diseases (such as systemic lupus erythematosus), malignant tumors, mental illness
5. Use of contraceptives, hormone replacement therapy (HRT), immunosuppressants and other drugs that affect ovarian function in the past 3 months.
6. Smokers (>5 cigarettes per day), alcoholics;
7. Unable to cooperate with follow-up or refuse to sign informed consent.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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16 participants in 1 patient group

Theronomic Ova-All Care

Experimental group

Description:

Active treatment - Theronomic Ova-All Care

Treatment:

Dietary Supplement: Theronomic Ova-All Care