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A Clinical Study on Changes in Phlegm-Dampness Constitution under Functional Food Intervention

A Clinical Study on Changes in Phlegm-Dampness Constitution under Functional Food Intervention

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026000931
Enrollment
Unknown
Registered
2026-04-09
Start date
2026-03-11
Completion date
Unknown
Last updated
2026-04-28

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

Conditions

Phlegm-dampness constitution

Interventions

Test Group:Chang Xinwei Oral Liquid + Shan Lexing Solid Beverage + Qing Shi Tablet
Control Group:Changxinwei Oral Liquid + Shanleixing Solid Beverage + Qingshi Tablet Placebo

Sponsors

The Third Affiliated Hospital of Fujian University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) Age between 18 and 65 years old; (2)simple phlegm-dampness constitution; (3) Have resided in the local area for one year or more and do not plan to leave the city in the next six months; (4) Voluntarily agree to participate in the study, with the informed consent process complying with GCP regulations.

Exclusion criteria

Exclusion criteria: (1) Patients with severe diseases such as cardio-cerebrovascular, pulmonary, hepatic, renal, and endocrine system disorders, or malignant tumors that require disease-specific management; (2) Individuals with gastrointestinal diseases or a history of gastrointestinal surgery that may affect product absorption; (3) Patients with secondary obesity: those with hypothalamic syndrome, pituitary tumors, Cushing's syndrome, hypothyroidism, hypogonadism, or hyperaldosteronism; (4) Pregnant or breastfeeding women; (5) Individuals unable to cooperate, such as those with intellectual disabilities, mental disorders, or impaired consciousness; (6) Individuals with allergies to multiple medications, components of the study product, or nut-containing foods; (7) Individuals who frequently use medications, consume alcohol, smoke, or have participated in other studies within the past 4 weeks; (8) Individuals undergoing or having undergone other physical condition adjustments within the past 3 months, including weight loss; (9) Individuals with symptoms or signs classified as severe.

Design outcomes

Primary

MeasureTime frame
Scoring of the TCM Body Constitution Classification and Assessment Form;Phlegm-dampness constitution quantitative scoring;Dampness Syndrome Scale Scoring;

Secondary

MeasureTime frame
Weight;Body Mass Index;waist;hip circumference;Waist-Hip Ratio;Limb measurements;Fasting Blood Glucose;glycated hemoglobin;Apolipoprotein A;Apolipoprotein B;Cholesterol;Triglyceride;High-Density Lipoprotein;Low-Density Lipoprotein;hemorheology;Periorbital swelling;skin oil;Scalp oil;Spirit;Skin Condition;tone;Sleep;

Countries

China

Contacts

Public ContactZhu Long

The Third Affiliated Hospital of Fujian University of Traditional Chinese Medicine

24435933@qq.com13950283526

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: May 1, 2026