Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:36 PM
Ignite Modification Date:
2025-12-24 @ 3:36 PM
NCT ID:
NCT03492892
Eligibility Criteria:
Inclusion Criteria:
* aged between 45 and 75 years;
* were diagnosed as stage I hypertension in the first visit, or used to be diagnosed with stage I hypertension in recent 1 year, but without any medication history;
* without neurological, other cardiovascular, hepatic and renal disease, and other visceral diseases;
* the basal metabolism rate of a patient, which was measured by the retrospective dietary questionnaire at baseline, should be approximately 1:1.4;
* didn't administer any drugs or herbs in at 15 days before the start of the study;
* didn't participate in any study other than this;
* agreed to cooperate with researchers in all research procedures after they were introduced this study; and
* provided with written informed consent.
Exclusion Criteria:
* age≤45 or age≥75;
* with hypertension which was secondary to other diseases, such as renal vascular disease, Cushing's syndrome, hyperadrenocorticism and drug-induced hypertension;
* had complicated cardiovascular, digestive, respiratory, urinary, blood, nervous, endocrine system and other severe primary diseases and failed to effectively control in clinic;
* accompanied by epilepsy, sleep apnea, hypopnea syndrome, etc.;
* with psychiatric symptoms such as severe depression or anxiety (SAS≥70, or SDS≥72);
* pregnant or lactating woman, or woman of reproductive age who was intended to conceive in recent 1 year;
* with abnormality in laboratory test of blood biochemistry, or with contagious risks, such as HIV virus carrier, or patient with positive Hepatitis B Virus (HBV) superficial antigen;
* with malignant tumor or other severe consuming diseases, or patients with infections or bleeding disorders;
* alcoholics or drug abusers, or vegetarians;
* used to suffer from acute diseases in recent 2 weeks, such as high fever, or gastritis;
* used to administer any drug that may potentially impaired renal or hepatic function;
* with cardiovascular disease that had been treated with acupuncture within recent three months; or
* undergoing other clinical trials.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
45 Years
Maximum Age:
75 Years
Study:
NCT03492892
Study Brief:
Protocol Section:
NCT03492892