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Cinnamon Extract on Menstrual Cycles in PolyCystic Ovary Syndrome (PCOS)

This study has been completed.
Sponsor:
Collaborator:
Integrity Nutraceuticals International
Information provided by (Responsible Party):
Rogerio A. Lobo, Columbia University
ClinicalTrials.gov Identifier:
NCT01483118
First received: November 29, 2011
Last updated: July 7, 2017
Last verified: June 2017
Results First Received: May 26, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Participant, Investigator;   Primary Purpose: Treatment
Condition: Polycystic Ovary Syndrome
Interventions: Drug: Cinnamon Extract
Dietary Supplement: Placebo

  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
Advertizing in newspaper beginning in August 2011

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
Cinnamon Extract Arm

Purified aqueous abstract of cinnamon in 125mg capsules

Cinnamon Extract: Purified aqueous abstract of cinnamon in 125mg capsules, which would be taken orally before each meal, for a total of 1,500mg/day for 6 months.

Placebo Arm

Placebo capsules containing ground cereal.

Placebo: Placebo capsules containing ground cereal.


Participant Flow:   Overall Study
    Cinnamon Extract Arm   Placebo Arm
STARTED   23   22 
Completed 3 Months   15   11 
COMPLETED [1]   11   6 
NOT COMPLETED   12   16 
Lost to Follow-up                12                16 
[1] (entire 6 months)



  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
Cinnamon Extract Arm

Purified aqueous abstract of cinnamon in 125mg capsules

Cinnamon Extract: Purified aqueous abstract of cinnamon in 125mg capsules, which would be taken orally before each meal, for a total of 1,500mg/day for 6 months.

Placebo Arm

Placebo capsules containing ground cereal.

Placebo: Placebo capsules containing ground cereal.

Total Total of all reporting groups

Baseline Measures
   Cinnamon Extract Arm   Placebo Arm   Total 
Overall Participants Analyzed 
[Units: Participants]
 23   22   45 
Age 
[Units: Years]
Mean (Full Range)
 26.95 
 (18 to 34) 
 27.86 
 (18 to 38) 
 27.5 
 (18 to 38) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      23 100.0%      22 100.0%      45 100.0% 
Male      0   0.0%      0   0.0%      0   0.0% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      8  34.8%      8  36.4%      16  35.6% 
Not Hispanic or Latino      14  60.9%      13  59.1%      27  60.0% 
Unknown or Not Reported      1   4.3%      1   4.5%      2   4.4% 
Region of Enrollment 
[Units: Participants]
     
United States   23   22   45 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Menses During the Six Month Study Period.   [ Time Frame: Up to 6 months ]

2.  Secondary:   Change in Insulin Resistance   [ Time Frame: Up to 6 months ]

3.  Secondary:   Change in Glucose Response   [ Time Frame: Up to 6 Months ]


  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
High percentage of patients lost to follow up


  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: Roger A. Lobo M.D.
Organization: Columbia University, Department of OBGYN
phone: 212-3056337
e-mail: ral35@columbia.edu


Publications:

Responsible Party: Rogerio A. Lobo, Columbia University
ClinicalTrials.gov Identifier: NCT01483118     History of Changes
Other Study ID Numbers: AAAI1377
Study First Received: November 29, 2011
Results First Received: May 26, 2016
Last Updated: July 7, 2017