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Clinical efficacy evaluation and related mechanism study of Ingredient-altered Chai-Gui Decoction on patients with Jueyin type hypertension

Clinical efficacy and mechanism study of Ingredient-altered Chai-Gui Decoction in treating Jueyin type hypertension

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400085731
Enrollment
Unknown
Registered
2024-06-17
Start date
2023-03-17
Completion date
Unknown
Last updated
2024-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Interventions

Treatment group:In addition to the treatment plan of the control group, oral Chai-gui decoction for treatment.
Control group:Add amlodipine tablets to those who have not used calcium channel blockers (CCBs)
Adjust types of CCBs for those who have already used CCBs.

Sponsors

Wuxi Hospital of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
30 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1) Meet the diagnostic standard of hypertension (systolic blood pressure = 140 mmHg and/or diastolic blood pressure = 90mm Hg for all three non same day measurements); meet the diagnostic criteria of traditional Chinese medicine for identifying diseases and syndromes of Jueyin type hypertension (main syndromes: ? dizziness, ? headache, ? pale complexion, ? emotional depression or worry; secondary syndromes: ? chest tightness and fullness, ? liking to sigh, ? sensation of foreign body in the throat, ? symptoms related to emotions, ? dry and astringent eyes, ? palpitations and palpitations, ? pale eyelids, ? accumulation of loose stools; tongue and pulse: tongue red or light red, with thin and white coating, and thin, flat or floating strings of pulse. The minimum satisfaction is 4 main symptoms, or 3 main symptoms + 2 secondary symptoms, or 2 main symptoms + 3 secondary symptoms or 1 main symptom + 4 secondary symptoms, and the tongue and pulse match); 2) First diagnosis of hypertension with no prior use of antihypertensive drugs or stable use of antihypertensive drugs for = 4 weeks with poor blood pressure control; 3) Diagnosed as grade 1 or grade 2 hypertension; 4) Aged between 18 and 85 years old (including boundary values); 5) Voluntary signing of informed consent form.

Exclusion criteria

Exclusion criteria: ? Secondary hypertension; ? Allergic constitution and allergy to this medicine; ? Severe arrhythmias, structural heart disease, and other acute cardiac diseases such as acute or severe cerebral infarction (acute phase), severe pulmonary insufficiency, etc; ? Renal insufficiency: male serum creatinine >2.5mg/dl (>220umol/L); female serum creatinine >2.0mg/dl (>175umol/L); ? Suffering from obvious liver diseases or liver function test values exceeding the upper normal limit by 2 times; ? Pregnancy or preparation for pregnancy, lactation period allergic to known ingredients of the investigational drug; ? Malignant tumors or researchers deemed it unsuitable to participate in this trial; ? Severe hematopoietic system diseases; ? Severe mental illness; ? Has participated or is currently participating in other clinical trials within the past three months; ? Unwilling to accept investigation.

Design outcomes

Primary

MeasureTime frame
Blood pressure;Scores for traditional Chinese medicine syndromes;

Secondary

MeasureTime frame
LPC (lysophosphatidylcholine);AA (Arachidonic acid);iPLA2 (Calcium-independent phospholipase A2);TNFa (Tumor necrosis factor-a);cGMP (Cyclic guanosine monophosphate);RGS2 (Regulator of G protein signaling 2);

Countries

China

Contacts

Public ContactJiang Yilin

Wuxi Hospital of Traditional Chinese Medicine

315306917@qq.com+86 183 5150 2808

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026