UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025391 |
|---|---|
| Receipt number | R000029232 |
| Scientific Title | Koujin powder (red ginseng powder) with Ninjin-youeito for fatigue due to molecular targeted therapy for advanced renal cell carcinoma |
| Date of disclosure of the study information | 2016/12/27 |
| Last modified on | 2021/04/14 13:40:44 |
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Basic information
Public title
Koujin powder (red ginseng powder) with Ninjin-youeito for fatigue due to molecular targeted therapy for advanced renal cell carcinoma
Acronym
Koujin powder (red ginseng powder) with Ninjin-youeito for fatigue due to molecular targeted therapy for advanced renal cell carcinoma
Scientific Title
Koujin powder (red ginseng powder) with Ninjin-youeito for fatigue due to molecular targeted therapy for advanced renal cell carcinoma
Scientific Title:Acronym
Koujin powder (red ginseng powder) with Ninjin-youeito for fatigue due to molecular targeted therapy for advanced renal cell carcinoma
Region
| Japan |
Condition
Condition
advanced renal cell carcinoma
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We explored the efficacy and safety of Koujin powder (red ginseng powder) with Ninjin-youeito for general fatigue induced by molecular targeted therapies for advanced RCC.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Using the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT - F), score the degree of fatigue / fatigue before and 2 weeks after administration of ginseng preparation and evaluate the change.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Oral administration of molecular targeted therapeutic drug (standard treatment) group
Observation period: 2 weeks
Interventions/Control_2
Molecular targeted therapeutic agent + 3 g of Koujin powder with 9 g of Ninjin-youeito orally before meals dosing group
Observation period: 2 weeks
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Of adult Japanese, patients diagnosed with advanced renal cancer
2) 1)), FACIT-f's "fatigue is present" among patients with molecular targeted drugs (brand name: Sutent, Votiento, Inirita) who have fatigue and fatigue as side effects Two or more patients each "feel tired" items
3) After receiving sufficient explanation for the participation of this study, patients who gained document consent by the patient's free will with sufficient understanding
Key exclusion criteria
1) Patients who can not ingest ginseng preparations
2) Patients who have allergies to traditional Chinese medicine
3) Patients who are pregnant, have a possibility of pregnancy, are within 28 days after birth, or who are breastfeeding
4) Patients with fatigue of CTC-AE grade 3 or higher, which is the criterion for terminating molecular targeted therapeutic drugs
5) Patients who recognize the rapid progress of disease
6) Patients taking steroids, Chinese medicines and ginseng preparations, other supplements supposedly effective for fatigue within 1 month
7) Patients with hypothyroidism (FT4 0.7 or lower), patients with advanced anemia (HGB decreases by 2 or more in one month)
8) Advanced renal dysfunction, daily urine volume reduction cases
9) Patients who are judged inappropriate for the study responsible doctor or the test sharing doctor to safely carry out this test
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Tomokazu |
| Middle name | |
| Last name | Sazuka |
Organization
Chiba University
Division name
Urology
Zip code
260-8677
Address
1-8-1, Inohana, chuo-ku ,chiba city
TEL
0432227171
tomo1ata2@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Tomokazu |
| Middle name | |
| Last name | Sazuka |
Organization
Chiba University
Division name
Urology
Zip code
260-8677
Address
1-8-1, Inohana, chuo-ku ,chiba city
TEL
0432227171
Homepage URL
tomo1ata2@yahoo.co.jp
Sponsor or person
Institute
Chiba University
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Chiba University Clinical Trials Division
Address
1-8-1, Inohana, chuo-ku ,chiba city
Tel
043-222-7171(6460)
chibacrc@mac.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 12 | Month | 27 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2016 | Year | 12 | Month | 21 | Day |
Date of IRB
| 2016 | Year | 12 | Month | 19 | Day |
Anticipated trial start date
| 2017 | Year | 01 | Month | 10 | Day |
Last follow-up date
| 2021 | Year | 04 | Month | 14 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 12 | Month | 23 | Day |
Last modified on
| 2021 | Year | 04 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029232
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