NCT05521282

The Efficacy of Qianglidingxuan Tablets in the Treatment of Hypertension

Completed Phase 4 Last updated 30 August 2022

What this trial tests

Phase 4 trial testing Treatment group in Hypertension in 269 participants. Completed in 30 June 2022.

Timeline

9 March 2021

Primary endpoint
3 June 2022

30 June 2022

Quick facts

Lead sponsor	Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	269
Start date	9 March 2021
Primary completion	3 June 2022
Estimated completion	30 June 2022
Sites	1 location across China

Drugs / interventions tested

• Treatment group

Conditions studied

• Hypertension — all drugs for Hypertension →
• Medicine, Chinese Traditional — all drugs for Medicine, Chinese Traditional →

Sponsor

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Who can join

Adults 18 to 75, any sex, with Hypertension or Medicine, Chinese Traditional. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Efficacy and safety of Qiangli Dingxuan tablet combined with amlodipine besylate for essential hypertension: a randomized, double-blind, placebo-controlled, parallel-group, multicenter trial.
   Lin J, Wang Q, Zhong D, Zhang J, et al · · 2023 · cited 2× · PMID 37492087 · DOI 10.3389/fphar.2023.1225529