The Efficacy of Qianglidingxuan Tablets in the Treatment of Hypertension

Status Completed

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05521282
Study type	Interventional
Source	Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Contact
Status	Completed
Phase	Phase 4
Start date	March 9, 2021
Completion date	June 30, 2022

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.