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To evaluate the efficacy and safety between Diane-35 and low-carbohydrate, ketogenic diet in patients with nonalcoholic fatty liver disease and polycystic ovary syndrome: a non-randomized, open, positive, parallel controlled prospective clinical study

To evaluate the efficacy and safety between Diane-35 and low-carbohydrate, ketogenic diet in patients with nonalcoholic fatty liver disease and polycystic ovary syndrome: a non-randomized, open, positive, parallel controlled prospective clinical study

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900024310
Enrollment
Unknown
Registered
2019-07-05
Start date
2019-08-01
Completion date
Unknown
Last updated
2019-10-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

nonalcoholic fatty liver disease

Interventions

Diane-35 treatment group:Oral Diane-35
Diane-35 combined ketogenic diet group:Oral Diane-35 combined ketogenic dietary guidance

Sponsors

Department of Infection, Foshan First People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 38 Years

Inclusion criteria

Inclusion criteria: 1.Aged 18 to 38 years; 2.The ultrasonic diagnosis was fatty liver. 3.According to the 2011 Chinese PCOS diagnostic criteria: menstrual thinning or amenorrhea or irregular uterine bleeding and meet one of the following two items: (1)high androgen clinical manifestations or hyperandrogenism; (2)ovarian polycystic Change by ultrasound. 4.Signing of informed consent. 5.The body mass index >= 24Kg/m2. 6.Agree not to participate in any other study.

Exclusion criteria

Exclusion criteria: 1.Other diseases that cause hyperandrogenism or high androgen symptoms: (1) Cushing's syndrome; (2) Non-classical congenital adrenal hyperplasia (NCCAH); (3) Tumors that secrete androgen in the ovary or adrenal gland; (4) Drug-like Hyperandrogenemia; (5) Family history of idiopathic hairy positive; 2.Other diseases that cause ovulation disorders: (1) Functional hypothalamic amenorrhea; (2) Thyroid disease: high PRL: (3) Early onset ovarian insufficiency (POI); 3.Viral liver disease, hepatolenticular degeneration, autoimmune liver disease, drug-induced liver disease and other causes of fatty liver or liver dysfunction, excluding long-term drinking history and alcohol intake equivalent to ethanol: male > 140g/Week, female > 70g/week. 4.Eating disorder or anorexia; 5.Previously or currently diagnosed HCC or other malignancies (meeting the appropriate diagnostic criteria); 6.Drug secondary fatty liver (tamoxifen, ethamiodarone, sodium valproate, methotrexate, glucocorticoid, etc). 7.Severe renal insufficiency = grade 3 (NYHA grade); 9.Lactation, pregnancy, perioperative period, smoking or alcoholic women; 10.Lack of pancreatic function, gallbladder disease, abdominal tumor or gastrointestinal disease, insulin use in patients with diabetes.

Design outcomes

Primary

MeasureTime frame
liver stiffness measurement;Controlled attenuation parameter;female hormones;Gynecological ultrasound;Menstrual cycle;Abdominal ultrasound;Body composition analysis;Blood chemistry;Body Mass Index;

Countries

China

Contacts

Public ContactYe Yinong

Department of infection, Foshan First People's Hospital

fsyyn001@126.com+86 0757-83161850

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026