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.
Timeline
- Start
- 2025-09-01
- Primary completion
- 2030-07-30
- Completion
- 2030-07-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Huanjingjian decoction | Traditional medicine (herbal / TCM) | 10 ml | — |
| Background | estradiol valerate | Unknown | 1 mg | Oral |
| Background | medroxyprogesterone acetate | Other / unclassified | 10 mg | — |