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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000025391
Receipt No. 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 2018/06/25

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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
Middle name
Last name kazuyoshi nakamura
Organization Chiba University
Division name Urology
Zip code
Address 1-8-1, Inohana, chuo-ku ,chiba city
TEL 043-222-7171
Email oarsmansoul2000@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name kazuyoshi nakamura
Organization Chiba University
Division name Urology
Zip code
Address 1-8-1, Inohana, chuo-ku ,chiba city
TEL 043-222-7171
Homepage URL
Email oarsmansoul2000@yahoo.co.jp

Sponsor
Institute Chiba University
Institute
Department

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
Address
Tel
Email

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 Open public recruiting
Date of protocol fixation
2016 Year 12 Month 21 Day
Date of IRB
Anticipated trial start date
2017 Year 01 Month 10 Day
Last follow-up date
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
2018 Year 06 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029232

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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