NCT05847959

The Relationship Between XinKang-I and Chronic Heart Failure

The Relationship Between XinKang-I and Chronic Heart Failure: Protocol for a Randomized Controlled Study.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 110 (estimated)
• Sponsor: Dongguan Hospital of Traditional Chinese Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

Background: Heart failure is the severe and terminal stage of various heart diseases, which is characterized by high morbidity, mortality and readmission. There are few studies on the relationship between XinKang-I(XK-I) and chronic heart failure. Objective: To explore the relationship between XK-I and chronic heart failure. Methods/design: The trial is a single-center, single-blind, randomized study (1:1). It will recruit 110 patients with chronic heart failure who syndrome of qi deficiency yang deficiency and blood stasis. The intervention group will receive not only Western medicine, but also XK-I. The primary end points will be the changes in oxygen consumption volume of anaerobic threshold (VO2AT), maximum oxygen volume uptake (VO2max), and 6-minute walking distance after 8 weeks of treatment. Both groups will receive 8 weeks of treatment. Ethics and dissemination: Ethical approval was granted by Ethics Committee of Dongguan TCM Hospital. Results will be disseminated via peer-reviewed publications and presentations at international conferences.

Conditions

• Traditional Chinese Medicine

Interventions

Type	Name	Description
DRUG	Traditional Chinese medicine prescription：XinKang-I	XK-I will be used in intervention group (20 grams of radix astragalus, 20 grams of radix codonopsis, 10 grams of stir-fried semen lepidii, 8 grams of sweet apricot kernel, 10 grams of cassia twig, 15 grams of poria cocos, 10 grams of atractylodes, 5 grams of honey-roasted licorice, 15 grams of radix et rhizoma salviae miltiorrhizae, 10 grams of chuanxiong rhizoma, 5 grams of tangerine peel).Patients will take XK-I once a day, divided into morning and evening administration. The treatment lasted for 8 weeks.

Timeline

• Start date: 2023-05-01
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2023-05-08
• Last updated: 2023-05-08