NCT05521282

The Efficacy of Qianglidingxuan Tablets in the Treatment of Hypertension

A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Qianglidingxuan Tablets in the Treatment of Mild to Moderate Essential Hypertension With Hyperactivity of Liver Yang

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 269 (actual)
• Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Research purpose: This study was a multicenter, randomized, double-blind, placebo-controlled, post-marketing clinical study in Chinese patients with essential hypertension to evaluate the efficacy and safety of Qianglidingxuan tablets(QLT) in the treatment of blood pressure in patients with mild to moderate essential hypertension. 1. Subject: Patients diagnosed as essential hypertension with clinical grade 1-2. 2. Interventions: ①Basic treatment plan:Patients in both groups were required to have a low-salt, low-fat diet, quit smoking, limit alcohol, eat more vegetables, moderate exercise, control body weight, and amlodipine besylate tablets (5mg, QD). ②Treatment group: Based on the basic treatment, QLT was given 6 tablets/time, 3 times a day, and warm water was given for 12 weeks. ③Control group: Based on basic treatment, QLT mimetic were given 6 tablets/time, 3 times a day, and warm water was given for 12 weeks. 3. Treatment and follow-up cycle: Patients in both groups were treated for 12 weeks and followed up to the end of 48th week after treatment. 4. Provisions of concurrent treatment: Any combined treatment used during the study should be recorded in the CRF, including drug name (generic name/trade name), starting time, administration dose, method of administration, termination time, indication, etc 5. Efficacy evaluation: ①Primary outcome measure: the change from baseline in office blood pressure after 12 weeks of treatment. ②Secondary efficacy indicators: 24-hour ambulatory blood pressure, heart rate, blood lipids, homocysteine, CRP, baPWV. TCM syndromes (including vertigo, headache, impatience and irritability, red face, red eyes, dry mouth, bitter mouth, tinnitus, insomnia, multiple dreams, constipation, urination, etc.) ③Safety indicators: adverse events, vital signs, physical examination, laboratory examination 6. Statistics: SAS® 9.4 was used for all statistical analyses.

Conditions

• Hypertension
• Medicine, Chinese Traditional

Interventions

Type	Name	Description
DRUG	Treatment group	Based on the basic treatment, Qianglidingxuan Tablets were given 6 tablets/time, 3 times a day, and warm water was given for 12 weeks.

Timeline

• Start date: 2021-03-09
• Primary completion: 2022-06-03
• Completion: 2022-06-30
• First posted: 2022-08-30
• Last updated: 2022-08-30

Locations

1 site across 1 country: China