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

Summary

Study Summary

This clinical trial aims to evaluate the efficacy and safety of the traditional Chinese herbal formula Huanjingjian decoction in women with premature ovarian insufficiency (POI). The study is designed to address the following key questions:

1. Does Huanjingjian decoction improve clinical symptoms in patients with POI?
2. What adverse medical events, if any, occur during the treatment with Huanjingjian decoction? To answer these questions, researchers will compare Huanjingjian decoction plus hormone replacement therapy (HRT) with placebo plus HRT, in order to determine whether Huanjingjian decoction provides additional therapeutic benefits in the management of POI.

Participants will:

Receiving either Huanjingjian decoction plus HRT, or placebo plus HRT. Attending monthly clinic visits over a 6-month period for clinical assessments and laboratory testing.

Keeping a detailed diary to record symptoms, treatment adherence, and menstrual flow, as measured by the number of sanitary pads used.

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.

Sponsors & Collaborators

• Shanghai University of Traditional Chinese Medicine

  collaborator OTHER

• Shanghai Geriatric Institute of Chinese Medicine

  collaborator UNKNOWN

• Shanghai Institute of Acupuncture and Anesthesia, Shanghai

  collaborator UNKNOWN

• Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

  collaborator OTHER

• Jingan Hospital of Traditional Chinese Medicine

  collaborator UNKNOWN

• Shanghai Pulmonary Hospital, Shanghai, China

  lead OTHER

Principal Investigators

• TE LIU, Doctor · Shanghai Geriatric Institute of Chinese Medicine

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

39 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-09-01

Primary Completion

2030-07-30

Completion

2030-07-30

Countries

• China

Study Locations