Efficacy and Safety of Huanjingjian Decoction in Women With Premature Ovarian Insufficiency

NANot yet recruitingINTERVENTIONAL
Enrollment

276

Participants

Timeline

Start Date

September 1, 2025

Primary Completion Date

July 30, 2030

Study Completion Date

July 30, 2030

Conditions
Premature Ovarian Insufficiency
Interventions
DRUG

Huanjingjian decoction

Participants will receive the traditional Chinese herbal formulation Huanjingjian decoction, administered at a dose of one vial (10 ml) twice daily, taken 30 minutes after breakfast and dinner. The intervention will commence immediately following the cessation of menstruation and will continue until the onset of the subsequent menstrual period. Upon the completion of each menstrual cycle, the treatment will be resumed. Each treatment course spans 28 days, with a total of three consecutive cycles administered.

DRUG

Hormone replacement therapy

Participants will begin oral administration of Utrogestan (estradiol valerate) on the 5th day of menstruation at a dose of 1 mg daily for 21 consecutive days. Starting from day 17 of treatment, medroxyprogesterone acetate will be added at a dose of 10 mg per day.

DRUG

Placebo

Participants will take the placebo oral solution at a dose of 10 mL twice daily (30 minutes after breakfast and dinner). The placebo intervention will commence immediately after the cessation of menstruation and will continue until the onset of the subsequent menstrual period. At the completion of each menstrual cycle, the treatment will be resumed. Each treatment course will last for 28 days, with a total of three consecutive cycles administered.

Trial Locations (1)

Unknown

Jingan hospital of Traditional Chinese Medicine, Shanghai

All Listed Sponsors
collaborator

Shanghai University of Traditional Chinese Medicine

OTHER

collaborator

Shanghai Geriatric Institute of Chinese Medicine

UNKNOWN

collaborator

Shanghai Institute of Acupuncture and Anesthesia, Shanghai

UNKNOWN

collaborator

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

OTHER

collaborator

Jingan Hospital of Traditional Chinese Medicine

UNKNOWN

lead

Shanghai Pulmonary Hospital, Shanghai, China

OTHER