The Formulation of Compound Phellinus Igniarius Decoction on Radiation Pneumonitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-22

Study Completion Date

2024-12-28

Brief Summary

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The objectives of this clinical trial were to determine the radioprotective effects and underlying biological mechanisms of Phellinus igniarius and its active components during radiotherapy in patients with thoracic malignant tumors.

The study group was given the formulation of Compound Phellinus igniarius decoction daily during radiotherapy, 150ml bid until the end of radiotherapy; The control group only received standard dose radiotherapy without the formulation of Compound Phellinus igniarius decoction intervention.

The baseline differences between the two groups were compared, including gender, smoking history, body mass index (BMI), pathological classification, median age of onset, inflammatory factors, tumor markers, TNM stage, KPS score, fatigue score, incidence and grade of radiation pneumonitis, incidence of other radiotherapy-related adverse reactions, and average radiation dose.

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Detailed Description

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Investigators measured the levels of inflammatory factors and tumor markers in blood samples of patients in the two income groups, and administered questionnaires on the degree of fatigue and general status of patients. Metabolite changes and gut microbiota homeostasis in patient fecal samples were then detected by untargeted metabolomics and metagenomics.

Conditions

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Radiation Pneumonitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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the effects of The formulation of Compound Phellinus igniarius decoction on radiation pneumonitis

The patients were randomly allocated into two groups, each comprising 20 patients. All patients received with DT: 50-60 Gy/20-30F thoracic radiotherapy, all with 6mv linear accelerator irradiation. The study group was defined as receiving the formulation of Compound Phellinus igniarius decoction, 150ml bid was administered continuously until the end of radiotherapy.

Group Type EXPERIMENTAL

The formulation of Compound Phellinus igniarius decoction

Intervention Type DRUG

The formulation of Compound Phellinus igniarius decoction is manufactured by Hangzhou Qianjifang Technology Co., Ltd, the composition includes Phellinus igniarius 12g, jujube 3g, wolfberry 3g, tangerine peel 1g. The dosage regimen was as follows: 4 Packs of the formulation of Compound Phellinus igniarius decoction (Phellinus igniarius Herbal Decoction Pieces) + 1 Pack of the formulation of Compound Phellinus igniarius decoction(Excipients) per day, administered twice daily throughout the entire course of radiotherapy until its completion.

The formulation of Compound Phellinus igniarius decoction on radiation pneumonitis

he patients were randomly allocated into two groups, each comprising 20 patients. All patients received with DT: 50-60 Gy/20-30F thoracic radiotherapy, all with 6mv linear accelerator irradiation. The control group was defined as receiving standard-dose radiotherapy without the administration of the formulation of Compound Phellinus igniarius decoction.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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The formulation of Compound Phellinus igniarius decoction

The formulation of Compound Phellinus igniarius decoction is manufactured by Hangzhou Qianjifang Technology Co., Ltd, the composition includes Phellinus igniarius 12g, jujube 3g, wolfberry 3g, tangerine peel 1g. The dosage regimen was as follows: 4 Packs of the formulation of Compound Phellinus igniarius decoction (Phellinus igniarius Herbal Decoction Pieces) + 1 Pack of the formulation of Compound Phellinus igniarius decoction(Excipients) per day, administered twice daily throughout the entire course of radiotherapy until its completion.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Age ≥18 years, ECOG score≤2, possess adequate communication and comprehension abilities, and have an anticipated survival time exceeding 6 months
* Confirmed diagnosis of lung malignancy through imaging and pathological examination
* Indications for thoracic radiotherapy, DT:50-60Gy/20-30F
* Normal function of vital organs, including the heart, liver, kidneys, and gastrointestinal system

Exclusion Criteria

* Patients with pre-existing pulmonary conditions, including idiopathic pulmonary fibrosis
* Individuals with systemic immune disorders
* Those with concurrent major infections
* Patients diagnosed with hematological disorders. All participants provided written informed consent

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No