A Phase 2 interventional study of RSYRT decoction and Astragalus membranaceus in Cancer-related Problem/Condition, sponsored by Peking University Cancer Hospital & Institute. Completed. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2019-04-16.
Sponsored by Peking University Cancer Hospital & Institute · Phase 2, Interventional, and Treatment
This randomized Phase II trial to establish the efficacy of traditional Chinese medicine (TCM) herbal products above control group for treating fatigue in patients with cancer.
Patients who were randomized and been enrolled in, had stable disease and no anemia, and reported moderate to severe fatigue over two months (rated ≥4 on a 0-10 scale). Patients took TCM decoction Renshen Yangrong decoction (RSYR),Which containing 12 TCM herbs, twice a day for 6 weeks. RSYRT aims to correct Qi deficiency. Fatigue was assessed before and after RSYRT therapy.
1,860 studies on the registry are indexed under Fatigue; 376 are open to participants now.
This study's enrollment of 92 is above the median of 54 across 1,440 interventional studies indexed under Fatigue.
Browse Fatigue studies →Peking University Cancer Hospital & Institute is the lead sponsor of 261 studies on the registry; 128 are open to participants now.
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Pathological diagnosis of malignant tumors; 3 months without surgery, radiotherapy and chemotherapy, biological treatment; Hemoglobin > 11g/L; Complete remission of the lesion, or recent review of the Disease is stable, the estimated survival time is more than 6 months; ECOG score is 0-2, fatigue score of the last 24 hours > 4 ; Age is 18-65 years old; TCM syndrome differentiation for deficiency of qi; Liver, kidney function, electrolyte normal; Willing to join the group and sign the informed consent.
Exclusion Criteria:
Allergies to herbs and plant drugs; Uncontrollable diabetes, hypertension, TSH abnormalities, uncontrollable pain, and a history of myocardial infarction within 6 months; Scores of anxiety disorders and depression (HAD-D) were 11 or more, antidepressants and antioxidants were used in the past month; Breast cancer receptor positive patients took endocrine therapy drugs; Tonics were used in the past 2 weeks.; Children, pregnant and lactating women; Receiving anemia-related treatment; Chinese medicine syndrome differentiation with excessive heat; Unable to read or understand the scale.
RSYYT decoction Compound granules of traditional Chinese medicine
Drug: RSYRT decoction
one herb decoction Compound granules of one herb (Astragalus membranaceus)
Drug: Astragalus membranaceus
Compound granules of traditional Chinese medicine
One herb
Fatigue score
Self-assessed 24-hour fatigue symptom score. According to the NCCN fatigue guide, the score is 0-10 points, 0 points means no fatigue, 10 points means the most serious fatigue that can be imagined.
Time frame: 6 weeks
No study locations are listed for this record.
Plan to share: Undecided
This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
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Peking University Cancer Hospital & Institute