Efficacy and Safety of Huanjingjian Decoction in Women With Premature Ovarian Insufficiency
Status:
NOT_YET_RECRUITING
Trial end date:
2030-07-30
Target enrollment:
Participant gender:
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.
Phase:
NA
Details
Lead Sponsor:
Shanghai Pulmonary Hospital, Shanghai, China
Collaborators:
Jingan Hospital of Traditional Chinese Medicine Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine Shanghai Geriatric Institute of Chinese Medicine Shanghai Institute of Acupuncture and Anesthesia, Shanghai Shanghai University of Traditional Chinese Medicine