NCT04788563

A Randomized Patient Preference Trial on Heat-sensitive Moxibustion for Primary Hypertension in Community

Heat-sensitive Moxibustion Self-administration for Primary Hypertension in Community: A Multicenter, Pragmatic, Randomized Controlled Trial With Patient Preference Arms

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 400 (actual)
• Sponsor: Jiangxi University of Traditional Chinese Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Heat-sensitive moxibustion, an important mean of external therapy of traditional Chinese medicine, has unique advantages in treating various chronic diseases than common moxibustion. This study aims to evaluate the efficacy, safety, and cost-effectiveness of heat-sensitive moxibustion for primary hypertension under community self-management setting using a multicenter, pragmatic, randomized controlled trial design with patient-preference arms.

Detailed description

Primary hypertension is a common chronic disease that threatens the life and health of human beings. The conventional western drug therapy often has side effects and many patients are unable to achieve ideal blood pressure control with drugs alone. Therefore, the treatment of primary hypertension still requires active exploration of complementary and alternative therapies with clear clinical efficacy. Heat-sensitive moxibustion is an innovative moxibustion therapy. By stimulating the patient's special moxibustion sensation, heat-sensitive moxibustion can achieve better results than traditional moxibustion for many diseases, including primary hypertension. Heat-sensitive moxibustion is an easy, inexpensive and safe treatment method. The practitioner does not need to be professionally qualified to perform moxibustion, making it a suitable technique for patients to self-medicate on a daily basis. Traditional moxibustion has been shown to lower blood pressure in patients with primary hypertension. Theoretically, heat-sensitive moxibustion could achieve better blood pressure lowering effects, but its effects in lowering blood pressure in the setting of self-management in community patients is unclear. To verify the efficacy and safety of heat-sensitive moxibustion community self-management for hypertension, we plan to perform a randomized controlled trial. In this trial, we designed the trial grouping scheme as a randomized controlled trial with patient preference arms in order to improve patient adherence and reduce the impact of patient preference effects.

Conditions

• Primary Hypertension

Interventions

Type	Name	Description
OTHER	Heat-sensitive moxibustion plus original antihypertensive treatment (compulsively randomized arm)	In this group, patients will self-administer heat-sensitive moxibustion or have family members help with the administration for six months. During this period, they will maintain their original antihypertensive treatment.
DRUG	Original antihypertensive treatment (compulsively randomized arm)	In this group, patients will maintain their original antihypertensive treatment.
OTHER	Heat-sensitive moxibustion plus antihypertensive treatment (voluntarily randomized arm)	In this group, patients will self-administer heat-sensitive moxibustion or have family members help with the administration for six months. During this period, they will maintain their original antihypertensive treatment.
DRUG	Original antihypertensive treatment (voluntarily randomized arm)	In this group, patients will maintain their original antihypertensive treatment.
OTHER	Heat-sensitive moxibustion plus original antihypertensive treatment (preference selection arm)	In this group, patients will self-administer heat-sensitive moxibustion or have family members help with the administration for six months. During this period, they will maintain their original antihypertensive treatment.
DRUG	Original antihypertensive treatment (preference selection arm)	In this group, patients will maintain their original antihypertensive treatment.

Timeline

• Start date: 2021-03-10
• Primary completion: 2021-12-09
• Completion: 2021-12-09
• First posted: 2021-03-09
• Last updated: 2024-07-03

Locations

7 sites across 1 country: China