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Long Term Chamomile Therapy for Anxiety

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01072344
First Posted: February 22, 2010
Last Update Posted: July 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Pennsylvania
Results First Submitted: April 28, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Generalized Anxiety Disorder
Intervention: Drug: Chamomile (Matricaria recutita)

  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
The study has 3 phases. The 1st phase is open label cham.(N=179), subjects meeting response criteria enter 2nd phase (N=93), the consolidation phase of open label chamomile. At the end of 2nd phase, if subjects still meet response criteria, they will enter the 3rd phase (N=93). In the 3rd phase, subjects will be randomized to chamomile vs. placebo.

Reporting Groups
  Description
Chamomile Extract

Pharmaceutical grade oral chamomile extract.

Chamomile (Matricaria recutita): 500 mg 3 times daily

Placebo

Pharmaceutical grade lactose monohydrate.

Chamomile (Matricaria recutita): 500 mg 3 times daily


Participant Flow:   Overall Study
    Chamomile Extract   Placebo
STARTED   46   47 
COMPLETED   35   29 
NOT COMPLETED   11   18 
Relasped-reached end point                7                12 
Protocol Violation                1                2 
Lost to Follow-up                3                4 



  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
Chamomile Extract

Pharmaceutical grade oral chamomile extract.

Chamomile (Matricaria recutita): 500 mg 3 times daily

Placebo

Pharmaceutical grade lactose monohydrate.

Chamomile (Matricaria recutita): 500 mg 3 times daily

Total Total of all reporting groups

Baseline Measures
   Chamomile Extract   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 46   47   93 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      40  87.0%      42  89.4%      82  88.2% 
>=65 years      6  13.0%      5  10.6%      11  11.8% 
Age 
[Units: Years]
Mean (Standard Deviation)
 49.2  (14.3)   45.4  (16.1)   47.3  (15.3) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      34  73.9%      31  66.0%      65  69.9% 
Male      12  26.1%      16  34.0%      28  30.1% 
Region of Enrollment 
[Units: Participants]
     
United States   46   47   93 


  Outcome Measures
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1.  Primary:   Time to Relapse in Each Treatment Condition.   [ Time Frame: 26 weeks ]

2.  Secondary:   The Proportion of Subjects in Each Treatment Condition Who Relapse.   [ Time Frame: 26 weeks ]

3.  Secondary:   Frequency, Severity, and Duration of Treatment-emergent Adverse Events.   [ Time Frame: 26 weeks ]

4.  Secondary:   Frequency of Discontinuation Symptoms at the Start of Double-blind Therapy in Each Treatment Condition.   [ Time Frame: 26 weeks ]

5.  Secondary:   Frequency of Early Study Discontinuation in Each Treatment Condition.   [ Time Frame: 26 weeks ]


  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:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Jun Mao
Organization: Memorial Sloan Kettering Cancer Center
phone: 646-888-0866
e-mail: maoj@mskcc.org


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01072344     History of Changes
Other Study ID Numbers: AT005074
First Submitted: February 18, 2010
First Posted: February 22, 2010
Results First Submitted: April 28, 2017
Results First Posted: July 6, 2017
Last Update Posted: July 6, 2017