The Efficacy of Qianglidingxuan Tablets in the Treatment of Hypertension

NCT05521282 | Completed Phase 4

• 1 other identifier: QLDXP-202002
• Study Type: interventional
• Target: 269
• Locations: 1 country
• Sites: 1

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. 1.Subject:
2. 2.Interventions:
3. 3.Treatment and follow-up cycle:
4. 4.Provisions of concurrent treatment:
5. 5.Efficacy evaluation:
6. 6.Statistics:

Conditions

Hypertension; Medicine, Chinese Traditional

Keywords

Hypertension; Qianglidingxuan tablet; Traditional Chinese medicine; Randomized controlled trial; Chinese patent medicine

Outcome Measures

Primary Outcomes (1)

• Clinic blood pressure

  Changes in systolic and diastolic blood pressure from baseline to follow up

  Baseline, month 4, month 12

Secondary Outcomes (6)

• 24-hour ambulatory blood pressure

  Baseline, month 4, month 12

• Heart rate

  Baseline, month 4, month 12

• Blood lipids

  Baseline, month 4, month 12

• BMI

  Baseline, month 4, month 12

• Homocysteine

  Baseline, month 4, month 12

Study Arms (2)

Treatment group

EXPERIMENTAL

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

Control group

PLACEBO COMPARATOR

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

Interventions

Treatment group DRUG

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

Control group; Treatment group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Secondary hypertension: renal hypertension (renovascular hypertension, renal parenchymal hypertension), pheochromocytoma, primary aldosteronism, Cushing syndrome, abdominal aortic coarctation, etc.
• Coronary atherosclerotic heart disease, acute attack of chronic heart failure, malignant arrhythmia, valvular heart disease, cardiomyopathy and other serious cardiovascular diseases.
• Acute cerebrovascular diseases such as cerebral infarction and cerebral hemorrhage.
• Severe psychological disorder, intellectual disability or language disorder, resulting in inability to fully cooperate with the study and inability to complete the study.
• 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.
• Allergic constitution or allergic to strong fixed glare tablets, excipients or similar ingredients of the trial drug.
• Suspected or with a history of alcohol or drug abuse.
• Pregnant, lactating women or those who plan to get pregnant recently or are unwilling to use contraceptive measures;.
• Patients who had participated in other clinical trials within 3 months before enrollment.
• Patients deemed by the investigator to be ineligible for enrollment in the trial.

Sponsors & Collaborators

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

Study Sites (1)

Guang'anmen Hospital, China Academy of Chinese Medical Sciences

Beijing, 100053, China

Location

Related Publications (1)

• Lin J, Wang Q, Zhong D, Zhang J, Yuan T, Wu H, Li B, Li S, Xie X, An D, Deng Y, Xian S, Xiong X, Yao K. Efficacy and safety of Qiangli Dingxuan tablet combined with amlodipine besylate for essential hypertension: a randomized, double-blind, placebo-controlled, parallel-group, multicenter trial. Front Pharmacol. 2023 Jul 10;14:1225529. doi: 10.3389/fphar.2023.1225529. eCollection 2023.

  PMID: 37492087 DERIVED

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Based on basic treatment, Qianglidingxuan mimetics were given 6 tablets/time, 3 times a day, and warm water was given for 12 weeks.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician

Model Details: Based on the basic treatment, Qianglidingxuan Tablets were given 6 tablets/time, 3 times a day, and warm water was given for 12 weeks.

Study Record Dates

• First Submitted: August 25, 2022
• First Posted: August 30, 2022
• Study Start: March 9, 2021
• Primary Completion: June 3, 2022
• Study Completion: June 30, 2022
• Last Updated: August 30, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)