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Cinnamon Bark, Water-Soluble Cinnamon Extract, and Metformin for Treatment of Type 2 DM.

This study has been terminated.
(lack of recruitment)
Sponsor:
Information provided by (Responsible Party):
Mike O'Callaghan Federal Hospital
ClinicalTrials.gov Identifier:
NCT01302743
First received: February 17, 2011
Last updated: May 31, 2017
Last verified: May 2017
Results First Received: December 15, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: Participant, Investigator;   Primary Purpose: Treatment
Condition: Diabetes
Interventions: Drug: Group 1: Metformin
Dietary Supplement: Group 2: Cinnamon Bark
Dietary Supplement: Group 3: Cinnulin PF

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Metformin

oral extended-release Metformin 1000 mg once a day for 90 days

Group 1: Metformin: Group 1: Will receive oral extended-release Metformin 1000 mg once a day for 90 days

Cinnamon Bark

Cinnamon Bark 1000 mg once a day for 90 days

Group 2: Cinnamon Bark: Group 2: Will receive Cinnamon Bark 1000 mg once a day for 90 days

Cinnulin PF

Cinnulin PF 500 mg once a day for 90 days

Group 3: Cinnulin PF: Group 3: Will receive Cinnulin PF 500 mg once a day for 90 days.


Participant Flow:   Overall Study
    Metformin   Cinnamon Bark   Cinnulin PF
STARTED   7   8   10 
COMPLETED   6   7   8 
NOT COMPLETED   1   1   2 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Metformin

oral extended-release Metformin 1000 mg once a day for 90 days

Group 1: Metformin: Group 1: Will receive oral extended-release Metformin 1000 mg once a day for 90 days

Cinnamon Bark

Cinnamon Bark 1000 mg once a day for 90 days

Group 2: Cinnamon Bark: Group 2: Will receive Cinnamon Bark 1000 mg once a day for 90 days

Cinnulin PF

Cinnulin PF 500 mg once a day for 90 days

Group 3: Cinnulin PF: Group 3: Will receive Cinnulin PF 500 mg once a day for 90 days.

Total Total of all reporting groups

Baseline Measures
   Metformin   Cinnamon Bark   Cinnulin PF   Total 
Overall Participants Analyzed 
[Units: Participants]
 7   8   10   25 
Age 
[Units: Participants]
Count of Participants
       
<=18 years      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      5  71.4%      4  50.0%      8  80.0%      17  68.0% 
>=65 years      2  28.6%      4  50.0%      2  20.0%      8  32.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      3  42.9%      4  50.0%      2  20.0%      9  36.0% 
Male      4  57.1%      4  50.0%      8  80.0%      16  64.0% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Decrease in HbA1c   [ Time Frame: 90 days ]

2.  Primary:   Decrease in LDL Cholesterol   [ Time Frame: 90 days ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Jill M. Clark, MBA/HCM
Organization: Mike O'Callaghan Federal Medical Center
phone: 702-653-3298
e-mail: jill.clark.3.ctr@us.af.mil



Responsible Party: Mike O'Callaghan Federal Hospital
ClinicalTrials.gov Identifier: NCT01302743     History of Changes
Other Study ID Numbers: FWH20110004H
Study First Received: February 17, 2011
Results First Received: December 15, 2016
Last Updated: May 31, 2017