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

NCT ID: NCT06081257

Last Updated: 2023-10-23

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-15

Study Completion Date

2024-07-05

Brief Summary

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"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.

Detailed Description

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Conditions

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Diminished Ovarian Reserve

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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experimental group

"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

Group Type EXPERIMENTAL

"KB-120" small molecular nutrient and vitamin E

Intervention Type DIETARY_SUPPLEMENT

The experimental group was given oral "KB-120" small molecular nutrients, once a day, once a bag (30ml), and vitamin E100mg orally twice a day for a total of 3 menstrual cycles

Vitamin E

Intervention Type DIETARY_SUPPLEMENT

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

control group

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

Group Type ACTIVE_COMPARATOR

Vitamin E

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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"KB-120" small molecular nutrient and vitamin E

The experimental group was given oral "KB-120" small molecular nutrients, once a day, once a bag (30ml), and vitamin E100mg orally twice a day for a total of 3 menstrual cycles

Intervention Type DIETARY_SUPPLEMENT

Vitamin E

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Women's Hospital School Of Medicine Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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IRB-20230158-R

Identifier Type: -

Identifier Source: org_study_id

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