Clinical trial NCT05521282: The Efficacy of Qianglidingxuan Tablets in the Treatment of Hypertension
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension
Medicine, Chinese Traditional
Keywords: Hypertension
Qianglidingxuan tablet
Traditional Chinese medicine
Randomized controlled trial
Chinese patent medicine
Lead sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Sponsor class: OTHER
Collaborators: name: The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
name: The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
name: Xinjiang Uygur Autonomous Region Hospital of Traditional Chinese Medicine
name: Jilin Provincial Hospital of Traditional Chinese Medicine, Affiliated Hospital of Changchun University of Traditional Chinese Medicine
First posted: 2022-08-30
Enrollment: 269
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Based on the basic treatment, Qianglidingxuan Tablets were given 6 tablets/time, 3 times a day, and warm water was given for 12 weeks.
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

1. Men and women aged 18-75 years.
2. Patients diagnosed as essential hypertension with clinical grade 1-2.
3. Diagnosis of hyperactivity of liver Yang upper syndrome by TCM syndrome differentiation.
4. Patients signed the informed consent with good compliance and could cooperate with the follow-up and review.

Exclusion Criteria:

1. Secondary hypertension: renal hypertension (renovascular hypertension, renal parenchymal hypertension), pheochromocytoma, primary aldosteronism, Cushing syndrome, abdominal aortic coarctation, etc.
2. Coronary atherosclerotic heart disease, acute attack of chronic heart failure, malignant arrhythmia, valvular heart disease, cardiomyopathy and other serious cardiovascular diseases.
3. Acute cerebrovascular diseases such as cerebral infarction and cerebral hemorrhage.
4. Severe psychological disorder, intellectual disability or language disorder, resulting in inability to fully cooperate with the study and inability to complete the study.
5. Any laboratory test index before screening met the following criteria: admission liver and kidney function indicated that ALT, AST \> 1.5 times the upper limit of normal value, Cr \> 1.2 times the upper limit of normal value (refer to the laboratory normal range of the research center); Other clinically significant laboratory abnormalities that were deemed unsuitable for enrollment by the investigator.
6. Allergic constitution or allergic to strong fixed glare tablets, excipients or similar ingredients of the trial drug.
7. Suspected or with a history of alcohol or drug abuse.
8. Pregnant, lactating women or those who plan to get pregnant recently or are unwilling to use contraceptive measures;.
9. Patients who had participated in other clinical trials within 3 months before enrollment.
10. Patients deemed by the investigator to be ineligible for enrollment in the trial.

Primary outcomes:
measure: Clinic blood pressure
timeFrame: Baseline, month 4, month 12
Secondary outcomes:
measure: 24-hour ambulatory blood pressure
timeFrame: Baseline, month 4, month 12
measure: Heart rate
timeFrame: Baseline, month 4, month 12
measure: Blood lipids
timeFrame: Baseline, month 4, month 12
measure: BMI
timeFrame: Baseline, month 4, month 12
measure: Homocysteine
timeFrame: Baseline, month 4, month 12
measure: C reactive protein
timeFrame: Baseline, month 4, month 12
Other outcomes:
Locations:
city: Beijing
country: China
facility: Guang'anmen Hospital, China Academy of Chinese Medical Sciences
Study officials:
References: