UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A doubled-blind, crossover-RCT in T2DM to evaluate the hypoglycemic effect of P. indicus, M. charantia, P. vulgaris and A. paniculata
Title of the study (Brief title)	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

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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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Mahalul Azam
Organization	Semarang State University
Division name	Center for Health and Biomedical Study, Research Institute
Address	Kampus UNNES Sekaran, Gunung Pati, Semarang
TEL	+62-8122853982
Email	mahalul.azam@mail.unnes.ac.id

Public contact
Name of contact person	Mahalul Azam
Organization	Semarang State University
Division name	Center for Health and Biomedical Study, Research Institute
Address	Kampus UNNES Sekaran, Gunung Pati, Semarang
TEL	+62-8122853982
Homepage URL	http://lp2m.unnes.ac.id/
Email	mahalul.azam@mail.unnes.ac.id

Sponsor
Institute	Semarang State University, Research Institute and Public Service (LP2M)
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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

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

Progress
Recruitment status	Completed
Date of protocol fixation	2009 Year 09 Month 07 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results	FPG level decresed after extract, glibenclamide and combination treatment Two-hour PPG level decreased after three treatments as well
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025865