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

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.

NCT Number	NCT07020429
Lead Sponsor	Shanghai Pulmonary Hospital, Shanghai, China Collaborators: Shanghai University of Traditional Chinese Medicine, Shanghai Geriatric Institute of Chinese Medicine, Shanghai Institute of Acupuncture and Anesthesia, Shanghai, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Jingan Hospital of Traditional Chinese Medicine
Conditions	Premature Ovarian Insufficiency
Enrollment	276 participants
Start Date	2025-09-01
Primary Completion	2030-07-30 (estimated)
Study Completion	2030-07-30 (estimated)
Updated on ClinicalTrials.gov	2025-09-08