NCT07020429

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

Efficacy and Safety of the Traditional Chinese Herbal Formula Huanjingjian Decoction in Women With Premature Ovarian Insufficiency: a Randomised Controlled Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 276 (estimated)
• Sponsor: Shanghai Pulmonary Hospital, Shanghai, China · Academic / Other
• Sex: Female
• Age: 18 Years – 39 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study is a prospective, randomized, controlled clinical trial designed to evaluate the efficacy of the traditional Chinese herbal formula Huanjingjian decoction in combination with hormone replacement therapy for the treatment of premature ovarian insufficiency. The primary objective is to determine whether the addition of Huanjingjian decoction to hormone replacement therapy provides greater improvement in clinical symptoms compared with placebo combined with hormone replacement therapy. It is hypothesized that, at 12 weeks, treatment with Huanjingjian decoction in combination with hormone replacement therapy will result in superior clinical outcomes relative to placebo combined with hormone replacement therapy.

Conditions

• Premature Ovarian Insufficiency

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-09-01
• Primary completion: 2030-07-30
• Completion: 2030-07-30
• First posted: 2025-06-13
• Last updated: 2025-09-08

Locations

1 site across 1 country: China