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A randomized, double-blind, dose-exploration, multi-center phase II clinical trial for the efficacy and safety of Peitu Qingxin (PTQX) Granules in the treatment of atopic dermatitis in children (heart fire and spleen deficiency syndrome)

A randomized, double-blind, dose-exploration, multi-center phase II clinical trial for the efficacy and safety of Peitu Qingxin (PTQX) Granules in the treatment of atopic dermatitis in children (heart fire and spleen deficiency syndrome)

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2000003901
Enrollment
Unknown
Registered
2020-09-08
Start date
2020-08-31
Completion date
Unknown
Last updated
2023-02-20

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

Conditions

Atopic dermatitis

Interventions

Sponsors

The First Teaching Hospital of Tianjin University of TCM
Lead Sponsor

Eligibility

Sex/Gender
All
Age
6 Years to 12 Years

Inclusion criteria

Inclusion criteria: 1. Patients who meet the diagnostic criteria of atopic dermatitis; 2. Patients who meet the syndrome differentiation standard of heart fire and spleen deficiency; 3. Patients aged 6-12 years (= 8 years old) should sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Contact dermatitis, chronic simple lichen, psoriasis, ichthyosis, enteropathic acrodermatitis, neonatal acne, peritrichokeratosis, scabies, etc; 2. Patients with acute lesions accompanied by erosion, exudation or severe skin infection, or local skin lesions with severe bacterial, fungal or viral infection; 3. Children with acute asthma or those who need systemic hormone maintenance therapy; 4. Children who had been treated with glucocorticoid, immunosuppressive agents and ultraviolet rays within 4 weeks before enrollment, antihistamines within 2 weeks before enrollment and topical drugs (such as TCS and TCI) within 1 week before enrollment; 5. Patients with other serious systemic diseases such as cardiovascular, brain, liver, kidney and hematopoietic system; 6. Patients who are allergic to known ingredients of the test drug; 7. Patients who are considered unsuitable by the researchers.

Design outcomes

Primary

MeasureTime frame
SCORAD score;

Secondary

MeasureTime frame
IGA score;Skin lesion recurrence;TCM syndrome score;CDLQI score;

Countries

China

Contacts

Public ContactLei Yang

Yuekang Pharmaceutical Group Co., Ltd

yanglei1020@126.com+86 13716841049

Outcome results

None listed

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