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Efficacy and safety of Traditional Chinese Medicine formula granules (Chuanjie granules) in the management of pulmonary pure ground-glass nodules: A multicenter triple-blind randomized controlled trial

Construction and demonstration of Traditional Chinese Medicine diagnosis and treatment system for pulmonary nodules/early ung cancer

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025001413
Enrollment
Unknown
Registered
2025-07-16
Start date
2025-09-01
Completion date
Unknown
Last updated
2025-07-21

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

Conditions

pulmonary pure ground-glass nodules

Interventions

Control Group:placebo
Intervention Group:Chuanjie granules

Sponsors

Hospital of Chengdu University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) An imaging report from the past three months identifies a pGGN as the largest pulmonary nodule deemed appropriate for active surveillance rather than surgical intervention following a multidisciplinary consultation; (2) Aged 18-75 years irrespective of sex; (3) Voluntarily providing written informed consent.

Exclusion criteria

Exclusion criteria: (1) Existing cancer or major organ disease; (2) Current respiratory infection; (3) The use of antibiotics hormonal therapies immunosuppressants or Chinese herbal medications within the preceding three months; (4) Psychiatric or cognitive issues hindering study compliance; (5) The state of pregnancy or lactation; (6) A known hypersensitivity to any component of the study product; (7) Concurrent participation in another clinical trial within the preceding month

Design outcomes

Primary

MeasureTime frame
The change in the maximum diameter of the pGGN from baseline;

Secondary

MeasureTime frame
Nodule density;Sf-36 (Short Form-36) score;Malignant risk of pulmonary nodules;Reduction rate of the maximum nodule diameter;Oral (saliva), intestinal (feces) flora characteristics;Anxiety and depression score;

Countries

China

Contacts

Public ContactYou Fengming

Hospital of Chengdu University of Traditional Chinese Medicine 39 Shi-er-qiao Road Chengdu Sichuan China.

yfmdoc@163.com+86 13981813945

Outcome results

None listed

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