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Phase II clinical trials of compound Danshen injection (recipe salvia miltiorrhiza lessen) radiotherapy adverse reaction of nasopharyngeal carcinoma

Phase II clinical trials of compound Danshen injection (recipe salvia miltiorrhiza lessen) radiotherapy adverse reaction of nasopharyngeal carcinoma

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-13003841
Enrollment
Unknown
Registered
2013-11-18
Start date
2014-03-01
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

nasopharyngeal carcinoma

Interventions

test team and control group:mouth care
test group and control group:skin care

Sponsors

Wuhan General Hospita of Guangzhou Military
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. The pathology of nasopharyngeal carcinoma; 2. To proceed radiotherapy in nasopharynx and / or neck; 3. KPS>=70; 4. Aged 18~70 years old; 5. The main organs (Heart, lung, liver, kidney, bone marrow, gastrointestinal) are in normal function (not more than WHO acute toxicity grading criteria I before treatment); 6. Without radiotherapy and chemotherapy contraindication; Leukocyte >=4×10^9/L, platelet >=100×10^9/L, Hb >=100g/L.

Exclusion criteria

Exclusion criteria: 1. Stage I patiengts(concurrent chemoradiotherapy is needn't); 2. Patients do not need or refuse chemotherapy radiotherapy; 3. Patients Once or also suffered from other malignant tumors; 4. Patients with bleeding tendency, and not suitable for the use of compound recipe salvia miltiorrhiza; 5. Allergic patients; 6. Pregnant or lactating.

Design outcomes

Primary

MeasureTime frame
blood routine;cutireaction;mouth opening degree;stomatiti;

Secondary

MeasureTime frame
blood biochemistry;EBV capsid antigen -IgG, EBV nuclear antigen;Electronic nasopharyngoscope;pathology;Chest X-ray or CT;Abdominal B ultrasound or CT;Nasopharynx and neck magnetic resonanc;

Countries

China

Contacts

Public ContactYi Fengtao

Wuhan General Hospita of Guangzhou Military

flzxyft@163.com+86 13971490116

Outcome results

None listed

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