UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022442 |
|---|---|
| Receipt number | R000025865 |
| Scientific Title | A doubled-blind, crossover-RCT in T2DM to evaluate the hypoglycemic effect of P. indicus, M. charantia, P. vulgaris and A. paniculata |
| Date of disclosure of the study information | 2016/05/24 |
| Last modified on | 2016/05/26 00:33:26 |
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Basic information
Public title
A doubled-blind, crossover-RCT in T2DM to evaluate the hypoglycemic effect of P. indicus, M. charantia, P. vulgaris and A. paniculata
Acronym
A doubled-blind, crossover-RCT in T2DM to evaluate the hypoglycemic effect of P. indicus, M. charantia, P. vulgaris and A. paniculata
Scientific Title
A doubled-blind, crossover-RCT in T2DM to evaluate the hypoglycemic effect of P. indicus, M. charantia, P. vulgaris and A. paniculata
Scientific Title:Acronym
A doubled-blind, crossover-RCT in T2DM to evaluate the hypoglycemic effect of P. indicus, M. charantia, P. vulgaris and A. paniculata
Region
| Asia(except Japan) |
Condition
Condition
type II DM (T2DM) patients
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to investigate the effect of mixture extract of Pterocarpus indicus, Momordica charantia, Phaseolus vulgaris and Andrographis paniculata on lowering plasma glucose (FPG and PPG) in T2DM
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase III
Assessment
Primary outcomes
Change from baseline in Fasting Plasma Glucose & Two hours Postprandial Plasma Glucose after single week therapy of daily single dose 22mg/kgBW mixture extract Pterocarpus indicus 20%, Momordica charantia 10%, Phaseolus vulgaris 40% and Andrographis paniculata 30%
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Treatment of Mixture Extract Pterocarpus indicus 20%, Momordica charantia 10%, Phaseolus vulgaris 40% and Andrographis paniculata 30%, daily single dose 22mg/kgBW
Treatment 1 assigned to group A, with daily dose of extract during meal at breakfast for a week, than continued to wash out period for a week as well, and continued to treatment 2 administration then will continued to receive combination administration treatment after second wash out period for a week
Interventions/Control_2
Treatment of Glibenclamide 5 mg
Assigned for group B in beginning of study, with daily single dose 5 mg Glibenclamide during meal at breakfast time for a week, than continued to wash out period for a week as well, and then switch to treatment 1 administration, then will continued to receive combination administration treatment after second wash out period for a week
Interventions/Control_3
Treatment of both combination of mixture extracts and glibenclamide 5 mg
Assigned for group A and B, after second washed out period, all subjects receive combination of both treatment administered during meal at breakfast for a week with the same dose as well
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
| 30 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
new or recently diganosed T2DM
men or women patients
Random Plasma Glucose (RPG) less then 400mg/dl,
had no insulin administration.
HbA1C level between 7-12mg/dl,
had no severe complication and other condition
Key exclusion criteria
Subjects that acquired complications or harm condition excluded from the study.
Subjects did not meet the instruction excluded from the study as well.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mahalul Azam |
Organization
Semarang State University
Division name
Center for Health and Biomedical Study, Research Institute
Zip code
Address
Kampus UNNES Sekaran, Gunung Pati, Semarang
TEL
+62-8122853982
mahalul.azam@mail.unnes.ac.id
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mahalul Azam |
Organization
Semarang State University
Division name
Center for Health and Biomedical Study, Research Institute
Zip code
Address
Kampus UNNES Sekaran, Gunung Pati, Semarang
TEL
+62-8122853982
Homepage URL
http://lp2m.unnes.ac.id/
mahalul.azam@mail.unnes.ac.id
Sponsor or person
Institute
Semarang State University,
Research Institute and Public Service (LP2M)
Institute
Department
Personal name
Funding Source
Organization
Research and Public Services Directorate
Directorate General of Higher Education
Ministry of Education
INDONESIA
Organization
Division
Category of Funding Organization
Outside Japan
Nationality of Funding Organization
Indonesia
Other related organizations
Co-sponsor
Public Health Departments, Semarang State University
Name of secondary funder(s)
PT Njonja Meneer
IRB Contact (For public release)
Organization
Address
Tel
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
Sultan Agung Islamic Hospital (Semarang)
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 05 | Month | 24 | 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
FPG level decresed after extract, glibenclamide and combination treatment
Two-hour PPG level decreased after three treatments as well
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
Completed
Date of protocol fixation
| 2009 | Year | 09 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 09 | Month | 14 | Day |
Last follow-up date
Date of closure to data entry
| 2010 | Year | 11 | Month | 19 | Day |
Date trial data considered complete
| 2010 | Year | 12 | Month | 20 | Day |
Date analysis concluded
| 2011 | Year | 04 | Month | 11 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 05 | Month | 24 | Day |
Last modified on
| 2016 | Year | 05 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025865
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
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