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

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.

Study Overview

• Status: Completed
• Conditions: Hypertension; Medicine, Chinese Traditional
• Intervention / Treatment: Drug: Treatment group

• Study Type: Interventional
• Enrollment (Actual): 269
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100053
    • Guang'anmen Hospital, China Academy of Chinese Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 71 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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. Qianglidingxuan Tablets: Specifications: 60 tablets per bottle; Storage: airtight, moisture-proof; Active ingredients:Gastrodia elata, Eucommia ulmoides, wild chrysanthemum, Eucommia ulmoides leaves, Chuanxiong; Manufacturer: Shaanxi Hanwang Pharmaceutical Co., LTD.	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.
Placebo Comparator: Control group; Based on basic treatment, Qianglidingxuan Tablets mimetics were given 6 tablets/time, 3 times a day, and warm water was given for 12 weeks. Qianglidingxuan Tablets mimetics: Specifications: 60 tablets per bottle; Storage: airtight, moisture-proof; Active ingredients:NA; Manufacturer: Shaanxi Hanwang Pharmaceutical Co., LTD.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinic blood pressure	Changes in systolic and diastolic blood pressure from baseline to follow up	Baseline, month 4, month 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
24-hour ambulatory blood pressure	Changes in daytime systolic BP, daytime diastolic blood pressure, nighttime systolic blood pressure, nighttime diastolic blood pressure, 24h mean systolic blood pressure, and 24h mean diastolic blood pressure from baseline to follow up	Baseline, month 4, month 12
Heart rate	Changes in heart rate from baseline to follow up	Baseline, month 4, month 12
Blood lipids	Changes in blood lipids（triglyceride, total cholesterol, low-density lipoprotein cholesterol, and high-density lipoprotein cholesterol）from baseline to follow up	Baseline, month 4, month 12
BMI	Changes in BMI from baseline to follow up	Baseline, month 4, month 12
Homocysteine	Changes in homocysteine from baseline to follow up	Baseline, month 4, month 12
C reactive protein	Changes in C reactive protein from baseline to follow up	Baseline, month 4, month 12

Collaborators and Investigators

• Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
• Collaborators: The First Affiliated Hospital of Henan University of Traditional Chinese Medicine; The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine; Xinjiang Uygur Autonomous Region Hospital of Traditional Chinese Medicine; Jilin Provincial Hospital of Traditional Chinese Medicine, Affiliated Hospital of Changchun University of Traditional Chinese Medicine

Study record dates

Study Major Dates

• Study Start (Actual): March 9, 2021
• Primary Completion (Actual): June 3, 2022
• Study Completion (Actual): June 30, 2022

Study Registration Dates

• First Submitted: August 25, 2022
• First Submitted That Met QC Criteria: August 26, 2022
• First Posted (Actual): August 30, 2022

Study Record Updates

• Last Update Posted (Actual): August 30, 2022
• Last Update Submitted That Met QC Criteria: August 26, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Hypertension; Randomized controlled trial; Traditional Chinese medicine; Qianglidingxuan tablet; Chinese patent medicine
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: QLDXP-202002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No