Evaluating the effectiveness of Sihogayonggolmoryeo-tang in pre-hypertensive or stage 1 hypertension patients with insomnia

Not Applicable

Recruiting

• Conditions: Not Applicable

• Registration Number: KCT0005001
• Lead Sponsor: Korea Institute of Oriental Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 15 June 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

(1) adults aged 19 years or over but under 80 years
(2) fulfilment of the The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnostic criteria for insomnia disorder
(3) total score of Insomnia Severity Index (ISI) =15 points
(4) patients with prehypertension (systolic blood pressure 120-139 mmHg or diastolic blood pressure 80-89 mmHg) or stage 1 hypertension (systolic blood pressure 140-159 mmHg or diastolic blood pressure 90-99 mmHg) defined by seventh report of joint national committee
(5) those who have voluntarily signed written informed consent forms approved by the institutional review board (IRB) after sufficient explanation about this study

Exclusion Criteria

(1) those who started taking sleep medication as needed to improve insomnia or who changed the type or dosage of a regularly taken sleep medication within 2 weeks prior to screening
(2) those who have taken herbal medicine to improve insomnia within 2 weeks prior to screening or who plan to take it to improve insomnia during the study period
(3) those who started Korean medicine treatment (acupuncture, moxibustion, or cupping therapy), dietary supplements, or other non-pharmacological therapies for the purpose of improving insomnia within 2 weeks prior to screening
(4) those diagnosed with other sleep disorders besides insomnia such as sleep-related breathing disorder, hypersomnia, circadian rhythm sleep disorder, restless leg syndrome, and periodic limb motor disorder
(5) working shifts or changes in day/night work schedule that can impact circadian rhythm
(6) those who have been diagnosed with major depressive disorder, anxiety disorder, panic disorder, or other psychiatric disorders or have a Patient Health Questionnaire-9 score = 10
(7) those who have pain severe enough to cause sleep disturbance
(8) uncontrolled thyroid function (abnormal level of free thyroxine (free T4) and thyroid-stimulating hormone (TSH) < 0.1 µIU/mL or TSH > 5.1 µIU/mL)
(9) those who have received antihypertensives, Korean medicine treatment (eg, acupuncture, moxibustion, cupping therapy, herbal medicine), dietary supplement, or other non-pharmacological therapies for the purpose of controlling blood pressure within 4 weeks prior to screening
(10) those with a history of aortic constriction, hyperaldosteroneemia, renal artery stenosis, Cushing's disease, chromophiloma, or polycystic kidney disease suspected of secondary hypertension
(11) those with a history of asthma, chronic obstructive pulmonary disease, cerebrovascular disease (stroke, transient ischemic attack), cardiovascular disease (myocardial infarction, angina pectoris, heart failure, valve disease), malignant tumors, and active tuberculosis within 6 months prior to screening
(12) uncontrolled diabetes mellitus with HbA1c = 9% or fasting blood glucose = 160 mg/dL
(13) women who are pregnant or lactating, or women who do not agree to use effective methods of contraception during the clinical trial
(14) severe liver or renal disease (aspartate aminotransferase (AST) or alanine aminotransferase (ALT) levels = 5 times the upper limit of normal or creatinine levels = 2 times the upper limit of normal)
(15) those with a history of alcohol abuse or drug abuse
(16) those with genetic problems, such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
(17) those who are less than 1 month from the end of the intervention in a previous clinical trial
(18) those who are thought to be unsuitable for participation in this clinical trial for other reasons

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Insomnia Severity Index

Secondary Outcome Measures

Name	Time	Method
sleep diary;Blood pressure (systolic and diastolic);Arteriosclerosis test;Pittsburgh Sleep Quality Index;Hospital Anxiety and Depression Scale;EuroQol Group - five dimensions - five level scale (EQ-5D-5L);liver and renal function test;adverse event;Patient Global Impression of Change;High-sensitivity C-reactive protein(hsCRP);Erythrocyte sedimentation rate(ESR);homocystein;fibrinogen