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Study on the Clinical Dose-Effect Relationship of Inflammation No.1 Formula Granules and Traditional Chinese Medicine Decoction Pieces in the Treatment of Mild to Moderate Atopic Dermatitis

Study on the Clinical Dose-Effect Relationship of Inflammation No.1 Formula Granules and Traditional Chinese Medicine Decoction Pieces in the Treatment of Mild to Moderate Atopic Dermatitis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026000452
Enrollment
Unknown
Registered
2026-03-03
Start date
2026-04-01
Completion date
Unknown
Last updated
2026-03-30

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

Conditions

Atopic dermatitis

Interventions

Decoction group of prepared slices:On the basis of basic treatment, take decoction made from herbal pieces
Formula granules conventional dose group:On the basis of basic treatment, take the regular dose of formula granules
Two-thirds dose group of granules:On the basis of basic treatment, take two-thirds of the dose of granules
Placebo (one-tenth dose of granules) group:On the basis of basic treatment, take a placebo (one-tenth dose of granules)

Sponsors

Shanghai Skin Disease Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: a) Aged 18-60, with no gender restrictions; b) The clinical diagnosis meets the diagnostic criteria of Western medicine for AD, with an Eczema Area and Severity Index (EASI) of =21, and a body surface area involvement percentage (BSA) ranging from 3% to 20%; c) Meet the criteria of the TCM syndrome of blood heat and wind excess or damp-heat accumulation; d) The overall investigator global assessment (IGA) is =3; e) The subjects fully understand the content of the trial, voluntarily participate in the trial, have signed the informed consent form, and are willing and able to follow the planned visits, treatment plan, laboratory tests, and other research procedures.

Exclusion criteria

Exclusion criteria: a) Women who are pregnant or breastfeeding; b) Patients who have systematically used immunosuppressants, JAK inhibitors, or biologics within 4 weeks; c) Those who are known to be allergic to any component of the drugs used in this clinical study; d) Patients with severe infections, immune deficiency diseases, active tumors, or severe heart, liver, or kidney diseases; e) Subjects with poor compliance or language comprehension issues who cannot cooperate with the clinical researcher to complete the study; f) Other situations that may pose significant risks to patients or confuse research results and should be excluded.

Design outcomes

Primary

MeasureTime frame
Eczema Area and Severity Index;

Secondary

MeasureTime frame
Investigator's Global Assessment;Body Surface Area;Dermatology Life Quality Index;Numerical Rating Scale;Patient-Oriented Eczema Measure;Traditional Chinese Medicine symptom scoring;

Countries

China

Contacts

Public ContactRuiping Wang

Shanghai Skin Disease Hospital

w19830901@126.com13816845803

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Jul 4, 2026