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A randomized, controlled clinical study of Dendrobium officinale granules against oral mucositis caused by tumor treatment

A randomized, controlled clinical study of Dendrobium officinale granules against oral mucositis caused by tumor treatment - A randomized, controlled clinical study of Dendrobium officinale granules against oral mucositis caused by tumor treatment

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300069861
Enrollment
Unknown
Registered
2023-03-28
Start date
2023-04-01
Completion date
Unknown
Last updated
2023-05-29

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

Conditions

Malignant tumor, oral mucositis

Interventions

Treatment Group:Iron sheet maple bucket particles
Control group:Sodium bicarbonate liquid

Sponsors

Shanghai Traditional Chinese Medicine-Integrated Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 90 Years

Inclusion criteria

Inclusion criteria: ? Meet the relevant diagnostic criteria of oral mucositis and the history of anti-tumor therapy; ? No analgesic drugs or vitamin preparations were used after onset; No antibiotics were used within 3 days prior to onset of illness. ? KPS score =80, no significant damage of liver and kidney function after chemotherapy (ALT<100U/L, AST<80U/L). (4) Informed consent to participate in the study.

Exclusion criteria

Exclusion criteria: ? Patients with Behcet's disease, recurrent necrotizing mucositis, herpetic stomatitis and other diseases that have been proven to cause erythema and/or ulceration of the oral mucosa, or oral mucositis caused by other causes other than chemotherapy; ? Usually have bad alcohol and tobacco addicts; ? Have mental illness, or have intellectual disabilities, their own judgment of pain intensity difficulty.

Design outcomes

Primary

MeasureTime frame
Mean ulcer stage;Pain score;Grade of oral mucositis;

Secondary

MeasureTime frame
T cell subpopulation;Inflammatory cytokines;Oral saliva sIgA, human ß-defensin 2 (HßD-2);Oral short-chain fatty acid producing bacteria and oral flora (Streptococcus, Veronella, Neisseria);

Countries

China

Contacts

Public ContactYi Zhong

Department of Oncology, Shanghai Traditional Chinese Medicine-Integrated Hospital

zhongzixian2000@163.com15800620886

Outcome results

None listed

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