Pilot intervention study on cluster randomized controlled trial of damp constitution in traditional Chinese Medicine

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2400082891

Enrollment

Unknown

Registered

2024-04-10

Start date

2024-04-12

Completion date

Unknown

Last updated

2024-04-15

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

Conditions

Metabolic disease

Interventions

experimental group 1 (metabolic abnormalities population with Phlegm-dampness constitution group):Chinese Medicine(pericarpium citri reticulatae,folium mori) fermentation liquor therapy

experimental group 2 (metabolic abnormalities population with damp-heat constitution group):Chinese Medicine(SEMEN COICIS, Lotus Leaf) fermentation liquor therapy

control group 1 (normal population with Phlegm-dampness constitution group):placebo

control group 2 (normal population with damp-heat constitution group):placebo

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Patients aged between 18-80 years; 2. Patients who meet the diagnosis of metabolic abnormalities in damp constitution; 3. Patients who accept the Chinese Medicine fermentation liquor therapy; 4. Patients who accept the clinical recommendation; 5. Patients who sign the informed consent.

Exclusion criteria

Exclusion criteria: 1.Preparing for pregnancy, pregnancy, or lactation population; 2. Mental disorders; 3. Acute attack period of various diseases; 4. Patients with major chronic diseases such as cardiovascular and cerebrovascular diseases during the treatment period 5. Patients who have participated in clinical trials of other drugs within the past 30 days; 6. Patients who cannot accept the treatment and follow-up measures.

Design outcomes

Primary

Measure	Time frame
score of Chinese Medicine Body Constitution phlegm-dampness and damp-heat constitution;	—

Secondary

Measure	Time frame
blood fat;blood sugar;serum uric acid;blood pressure;body mass index (BMI);Waist to hip ratio;Disease incidence evaluation: cardiovascular and cerebrovascular events;Prediction and evaluation of cardiovascular and cerebrovascular diseases: Framingham prediction model integration;	—

Countries

China

Contacts

Public ContactLi Huang

Guangdong provincial hospital of Chinese Medicine

liea1981@126.com+86 135 7044 2252

Outcome results

None listed

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