Clinical trial · Interventional
Effect of Sipjeondaebo-tang for Cancer Related Anorexia in Cancer Patients
Effect of Sipjeondaebo-tang for Cancer Related Anorexia in Cancer Patients: A Randomized Double Blinded Placebo Controlled Pilot Study
NCT02468141CI-TRIAL-00028721completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To determine efficacy and safety of Sipjeondaebo-tang for Cancer patients suffering from anorexia after chemotherapy. Sipjeondaebo-tang will be administered for 4 weeks, 3 times per day after a meal. Changes of FAACT scale, Anorexia VAS, Weight, BMI, Clinical laboratory test such as ACTH, Cortisol, Chrelin, IL-6, ESR, CRP will be measured and analyzed.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer-related Problem/Condition | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Placebo | Drug | — | UNRESOLVED |
| SJDBT | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- SJDBT group
- description
- Herbal medicine
- interventionNames
- Drug: SJDBT
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Placebo control
- interventionNames
- Drug: Placebo
Primary outcomes (1)
- measure
- The Functional Assessment of Anorexia/Cachexia Therapy - Anorexia Cachexia Subscale
- timeFrame
- 4 weeks
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Men and women ages 20 to 80 years * Individuals who are suffering from cancer-associated anorexia * Patients within 1 month after completion of chemotherapy * No plan for additional chemotherapy or radiotherapy * Anorexia visual analogue scale (VAS) ≥ 40/100mm * Qi deficiency scale ≥ 30 or Blood deficiency scale ≥ 30 * Neutrophil ≥ 1,500/㎕, platelet ≥ 100,000/㎕ * Total bilirubin lower than upper limit of normal (1.2 mg/㎗) * ALT, AST lower than 2-fold the upper limit of normal * Creatinine lower than 1.5 fold the upper limit of normal(1.09 mg/㎗) * Written informed consent for participation in the trial Exclusion Criteria: * Patient impossible to oral intake * Patient 5 years after cancer diagnosis * ECOG performance status score \> 3 * Patient with dementia, delirium, depression * Patient who complain of more than 7 points when we use Numeric Rating Scale, which can affect appetite or calorie intake, within 2 weeks of screening * Patient with diseases which can influence on appetite (such as hypoadrenalism, etc) * Patient who are taking appetizers (such as megestrol acetate, corticosteroids, thalidomide) * Women who has possibility of a pregnancy * Others who are judged not to be appropriate to study
References
Publications (2)
- DERIVEDCheon C, Yoo JE, Yoo HS, Cho CK, Kang S, Kim M, Jang BH, Shin YC, Ko SG. Efficacy and Safety of Sipjeondaebo-Tang for Anorexia in Patients with Cancer: A Pilot, Randomized, Double-Blind, Placebo-Controlled Trial. Evid Based Complement Alternat Med. 2017;2017:8780325. doi: 10.1155/2017/8780325. Epub 2017 Dec 26. PMID 29441116
- DERIVEDCheon C, Park S, Park YL, Huang CW, Ko Y, Jang BH, Shin YC, Ko SG. Sipjeondaebo-tang in patients with cancer with anorexia: a protocol for a pilot, randomised, controlled trial. BMJ Open. 2016 May 12;6(5):e011212. doi: 10.1136/bmjopen-2016-011212. PMID 27173813