Trial Outcomes & Findings for Long Term Chamomile Therapy for Anxiety (NCT NCT01072344)
NCT ID: NCT01072344
Last Updated: 2017-07-06
Results Overview
The primary outcome was time to relapse during continuation therapy, analyzed using Cox proportional hazards. Relapse is dichotomously defined as an increase in CGI/S (a clinician-rated global measure of anxiety's severity) score from ≤ 3 (at study visit 6) to ≥ 4 (on two consecutive scheduled or unscheduled study visits ≥ 2 weeks apart) plus meeting DSM IV-TR criteria for GAD (minus the 6-month time criterion).
COMPLETED
PHASE3
180 participants
26 weeks
2017-07-06
Participant Flow
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.
Participant milestones
| Measure |
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
|
|---|---|---|
|
Overall Study
STARTED
|
46
|
47
|
|
Overall Study
COMPLETED
|
35
|
29
|
|
Overall Study
NOT COMPLETED
|
11
|
18
|
Reasons for withdrawal
| Measure |
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
|
|---|---|---|
|
Overall Study
Relasped-reached end point
|
7
|
12
|
|
Overall Study
Protocol Violation
|
1
|
2
|
|
Overall Study
Lost to Follow-up
|
3
|
4
|
Baseline Characteristics
Long Term Chamomile Therapy for Anxiety
Baseline characteristics by cohort
| Measure |
Chamomile Extract
n=46 Participants
Pharmaceutical grade oral chamomile extract.
Chamomile (Matricaria recutita): 500 mg 3 times daily
|
Placebo
n=47 Participants
Pharmaceutical grade lactose monohydrate.
Chamomile (Matricaria recutita): 500 mg 3 times daily
|
Total
n=93 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
40 Participants
n=93 Participants
|
42 Participants
n=4 Participants
|
82 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
11 Participants
n=27 Participants
|
|
Age, Continuous
|
49.2 years
STANDARD_DEVIATION 14.3 • n=93 Participants
|
45.4 years
STANDARD_DEVIATION 16.1 • n=4 Participants
|
47.3 years
STANDARD_DEVIATION 15.3 • n=27 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=93 Participants
|
31 Participants
n=4 Participants
|
65 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=93 Participants
|
16 Participants
n=4 Participants
|
28 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
46 participants
n=93 Participants
|
47 participants
n=4 Participants
|
93 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 26 weeksPopulation: All 93 subjects started randomization phase of the study were included in the analysis
The primary outcome was time to relapse during continuation therapy, analyzed using Cox proportional hazards. Relapse is dichotomously defined as an increase in CGI/S (a clinician-rated global measure of anxiety's severity) score from ≤ 3 (at study visit 6) to ≥ 4 (on two consecutive scheduled or unscheduled study visits ≥ 2 weeks apart) plus meeting DSM IV-TR criteria for GAD (minus the 6-month time criterion).
Outcome measures
| Measure |
Chamomile Extract
n=46 Participants
Pharmaceutical grade oral chamomile extract.
Chamomile (Matricaria recutita): 500 mg 3 times daily
|
Placebo
n=47 Participants
Pharmaceutical grade lactose monohydrate.
Chamomile (Matricaria recutita): 500 mg 3 times daily
|
|---|---|---|
|
Time to Relapse in Each Treatment Condition.
|
11.4 weeks
Standard Deviation 8.4
|
6.3 weeks
Standard Deviation 3.9
|
SECONDARY outcome
Timeframe: 26 weeksPopulation: During phase II consolidation phase, treatment responders were randomized to either 26 weeks of continuation chamomile therapy or placebo.
The proportion of subjects in each treatment condition who relapsed after randomization
Outcome measures
| Measure |
Chamomile Extract
n=46 Participants
Pharmaceutical grade oral chamomile extract.
Chamomile (Matricaria recutita): 500 mg 3 times daily
|
Placebo
n=47 Participants
Pharmaceutical grade lactose monohydrate.
Chamomile (Matricaria recutita): 500 mg 3 times daily
|
|---|---|---|
|
The Proportion of Subjects in Each Treatment Condition Who Relapse.
|
7 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: 26 weeksPopulation: During phase II consolidation phase, treatment responders were randomized to either 26 weeks of continuation chamomile therapy or placebo.
We will report the frequency, severity, and duration of treatment-emergent adverse events by treatment arm.
Outcome measures
| Measure |
Chamomile Extract
n=46 Participants
Pharmaceutical grade oral chamomile extract.
Chamomile (Matricaria recutita): 500 mg 3 times daily
|
Placebo
n=47 Participants
Pharmaceutical grade lactose monohydrate.
Chamomile (Matricaria recutita): 500 mg 3 times daily
|
|---|---|---|
|
Frequency, Severity, and Duration of Treatment-emergent Adverse Events.
|
8 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: 26 weeksPopulation: These are responders at the end of Phase II of the study and then were randomized in Phase III of the study
Discontinuation emergent signs and symptoms checklist (DESS) is a patient-rated measure of the presence and severity of discontinuation symptoms occurring after medication discontinuation. %
Outcome measures
| Measure |
Chamomile Extract
n=46 Participants
Pharmaceutical grade oral chamomile extract.
Chamomile (Matricaria recutita): 500 mg 3 times daily
|
Placebo
n=47 Participants
Pharmaceutical grade lactose monohydrate.
Chamomile (Matricaria recutita): 500 mg 3 times daily
|
|---|---|---|
|
Frequency of Discontinuation Symptoms at the Start of Double-blind Therapy in Each Treatment Condition.
# of subject had >=1 new symptom after randomizati
|
14 Participants
|
11 Participants
|
|
Frequency of Discontinuation Symptoms at the Start of Double-blind Therapy in Each Treatment Condition.
# of subject had no new symptoms after randomizat
|
31 Participants
|
33 Participants
|
SECONDARY outcome
Timeframe: 26 weeksPopulation: These are responders at the end of Phase II of the study and were then randomized into Phase III of the study.
This is the # of subjects who discontinued the study during randomization phase due to other reasons.
Outcome measures
| Measure |
Chamomile Extract
n=46 Participants
Pharmaceutical grade oral chamomile extract.
Chamomile (Matricaria recutita): 500 mg 3 times daily
|
Placebo
n=47 Participants
Pharmaceutical grade lactose monohydrate.
Chamomile (Matricaria recutita): 500 mg 3 times daily
|
|---|---|---|
|
Frequency of Early Study Discontinuation in Each Treatment Condition.
# Lost to Follow-up
|
3 Participants
|
4 Participants
|
|
Frequency of Early Study Discontinuation in Each Treatment Condition.
# withdrawn due to non-compliance
|
1 Participants
|
2 Participants
|
Adverse Events
Chamomile Extract
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Chamomile Extract
n=46 participants at risk
Pharmaceutical grade oral chamomile extract.
Chamomile (Matricaria recutita): 500 mg 3 times daily
|
Placebo
n=47 participants at risk
Pharmaceutical grade lactose monohydrate.
Chamomile (Matricaria recutita): 500 mg 3 times daily
|
|---|---|---|
|
Product Issues
taste perversion
|
2.2%
1/46 • Number of events 1
|
4.3%
2/47 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Bruising
|
0.00%
0/46
|
4.3%
2/47 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Congestion
|
2.2%
1/46 • Number of events 1
|
2.1%
1/47 • Number of events 1
|
|
Blood and lymphatic system disorders
Decreased platelet count
|
0.00%
0/46
|
4.3%
2/47 • Number of events 2
|
|
Gastrointestinal disorders
Diarrhea
|
2.2%
1/46 • Number of events 1
|
0.00%
0/47
|
|
Nervous system disorders
Dizziness
|
2.2%
1/46 • Number of events 1
|
0.00%
0/47
|
|
Nervous system disorders
Drowsiness
|
2.2%
1/46 • Number of events 1
|
0.00%
0/47
|
|
General disorders
Dry mouth
|
4.3%
2/46 • Number of events 2
|
0.00%
0/47
|
|
General disorders
Fatigue
|
2.2%
1/46 • Number of events 1
|
0.00%
0/47
|
|
Skin and subcutaneous tissue disorders
Flushing
|
2.2%
1/46 • Number of events 1
|
0.00%
0/47
|
|
General disorders
Herbal taste
|
2.2%
1/46 • Number of events 1
|
0.00%
0/47
|
|
Gastrointestinal disorders
Nausea
|
6.5%
3/46 • Number of events 3
|
0.00%
0/47
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/46
|
2.1%
1/47 • Number of events 1
|
|
Ear and labyrinth disorders
Ringing in ears
|
0.00%
0/46
|
2.1%
1/47 • Number of events 1
|
|
General disorders
Sleep paralysis
|
0.00%
0/46
|
2.1%
1/47 • Number of events 1
|
|
Renal and urinary disorders
Urinary frequency
|
2.2%
1/46 • Number of events 1
|
0.00%
0/47
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place