The Effect of "KB-120" Small Molecular Nutrient in Women With Decreased Ovarian Reserve

Women's Hospital School Of Medicine Zhejiang University

Status: Not yet enrolling

Conditions: Diminished Ovarian Reserve

Treatments: Dietary Supplement: Vitamin E; Dietary Supplement: "KB-120" small molecular nutrient and vitamin E

Study type: Interventional

Funder types: Other

Identifiers

NCT06081257

IRB-20230158-R

Details and patient eligibility

About

"KB-120" small molecular nutrient is a structural multi-molecular natural nutrient with different components. It is produced from strains and natural plant culture-medium that can be used in food and is designed according to different efficacy of different products by multi-stage solid-liquid complex fermentation technology. The functional directions of the product series involved are: immune function damage repair, intestinal villi damage repair, sperm development machinery damage repair, ovarian function damage repair, liver function damage repair, sleep disorder function damage repair, etc.Previous studies have shown that "KB-120" has good clinical effects on improving the number and function of male germ cells.Luanbao "KB-120" is a compound plant health drink specially for women. This study intends to give "KB-120" small molecule nutrients as nutritional supplement intervention in female patients with ovarian dysfunction, and observe its influence on endocrine function, ovarian reserve function and fertility in patients with ovarian dysfunction.

Enrollment: 80 estimated patients

Sex: Female

Ages: 20 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Patients with low ovarian function: FSH ≥10IU/L or AMH ≤1.1ng/ml.
2. The age at the time of signing the informed consent is 20-40 years old (including 20 and 40 years old) and has not been menopausal;
3. Be willing to sign written informed consent and comply with the study protocol

Exclusion criteria

1. Patients with severe anemia or malignant tumor; Lactation or pregnancy;
2. Eating disorders or anorexia;
3. Taking hormone drugs or participating in any other study.
4. There are factors that researchers believe cannot be included in the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

experimental group

Experimental group

Description:

"KB-120" small molecule nutrients, taken orally once a day in one bag (30ml), and vitamin E100mg taken orally 2 times a day for a total of 3 menstrual cycles

Treatment:

Dietary Supplement: Vitamin E

Dietary Supplement: "KB-120" small molecular nutrient and vitamin E

control group

Active Comparator group

Description:

Vitamin E100mg is taken orally twice a day for a total of 3 menstrual cycles

Treatment:

Dietary Supplement: Vitamin E