Trial Outcomes & Findings for Chamomile for Chronic Primary Insomnia (NCT NCT01286324)

Results Overview

Change from baseline of chamomile extract, three tablets (equivalent to 7.5 g of dried herb) p.o. twice times daily versus placebo on the following sleep measures at 28 days: * the change from baseline of daily self-report of sleep as assessed by a sleep diary that includes determination of: (i) sleep efficiency, which equals "The total sleep time divided by time-in-bed, multiplied by 100." This measure is our primary aim (SE).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

34 participants

Primary outcome timeframe

baseline and day 28

Results posted on

2017-11-07

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo Tablet Contained lactose	Chamomile High Grade Extract Each capsule contains 90 mg dry extract of chamomile flowering tops \[6:1 (v/v) extraction solvent (ethanol 70%/30% water): flowering tops\] standardized up to 2.5 mg of (-)-α-bisabolol and ≥ 2.5 mg of apigenin per tablet
Overall Study STARTED	17	17
Overall Study COMPLETED	17	17
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Chamomile for Chronic Primary Insomnia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo Tablet n=17 Participants Contained lactose	Chamomile High Grade Extract n=17 Participants Each capsule contains 90 mg dry extract of chamomile flowering tops \[6:1 (v/v) extraction solvent (ethanol 70%/30% water): flowering tops\] standardized up to 2.5 mg of (-)-α-bisabolol and ≥ 2.5 mg of apigenin per tablet	Total n=34 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	17 Participants n=5 Participants	17 Participants n=7 Participants	34 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	40.8 years STANDARD_DEVIATION 15.3 • n=5 Participants	42.2 years STANDARD_DEVIATION 13.5 • n=7 Participants	41.4 years STANDARD_DEVIATION 14.2 • n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants	12 Participants n=7 Participants	25 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Region of Enrollment United States	17 participants n=5 Participants	17 participants n=7 Participants	34 participants n=5 Participants

PRIMARY outcome

Timeframe: baseline and day 28

Change from baseline of chamomile extract, three tablets (equivalent to 7.5 g of dried herb) p.o. twice times daily versus placebo on the following sleep measures at 28 days: * the change from baseline of daily self-report of sleep as assessed by a sleep diary that includes determination of: (i) sleep efficiency, which equals "The total sleep time divided by time-in-bed, multiplied by 100." This measure is our primary aim (SE).

Outcome measures

Outcome measures
Measure	Placebo Tablet n=17 Participants Contained lactose	Chamomile High Grade Extract n=17 Participants Each capsule contains 90 mg dry extract of chamomile flowering tops \[6:1 (v/v) extraction solvent (ethanol 70%/30% water): flowering tops\] standardized up to 2.5 mg of (-)-α-bisabolol and ≥ 2.5 mg of apigenin per tablet
Change From Baseline of Chamomile Extract on Measures of Sleep at Day 28.	83.3 percentage of time asleep Standard Deviation 7.7	77.5 percentage of time asleep Standard Deviation 12.9

SECONDARY outcome

Timeframe: baseline and day 28

Change from baseline of chamomile extract, three tablets p.o. twice times daily versus placebo on daytime functioning measures at 28 days: * the change from baseline of measures of depression and anxiety evaluated respectively with the Beck Depression Inventory-II (BDI-II), which is scored on a scale of 0 to 63 where a total score of 0-13 is considered minimal range (minimal depression), 14-19 is mild, 20-28 is moderate, and 29-63 is severe.

Outcome measures

Outcome measures
Measure	Placebo Tablet n=17 Participants Contained lactose	Chamomile High Grade Extract n=17 Participants Each capsule contains 90 mg dry extract of chamomile flowering tops \[6:1 (v/v) extraction solvent (ethanol 70%/30% water): flowering tops\] standardized up to 2.5 mg of (-)-α-bisabolol and ≥ 2.5 mg of apigenin per tablet
Change From Baseline of Chamomile on Daytime Functioning Measures: BDI Post-treatment	4.8 units on a scale Standard Deviation 5.0	2.4 units on a scale Standard Deviation 2.4
Change From Baseline of Chamomile on Daytime Functioning Measures: BDI Pre-treatment	6.0 units on a scale Standard Deviation 6.0	3.2 units on a scale Standard Deviation 1.6

SECONDARY outcome

Timeframe: Baseline and 28 days

Change From Baseline of Chamomile on Daytime Functioning Measures, depression and anxiety evaluated respectively with the Beck Depression Inventory-II (BDI-II) and trait portrait of the State Trait Anxiety Index (STAI). STAI scores range for each subtest from 20-80, the higher score indicating greater anxiety. A cut point of 39-40 has been suggested to detect clinically significant symptoms for the S-Anxiety scale

Outcome measures

Outcome measures
Measure	Placebo Tablet n=17 Participants Contained lactose	Chamomile High Grade Extract n=17 Participants Each capsule contains 90 mg dry extract of chamomile flowering tops \[6:1 (v/v) extraction solvent (ethanol 70%/30% water): flowering tops\] standardized up to 2.5 mg of (-)-α-bisabolol and ≥ 2.5 mg of apigenin per tablet
Change From Baseline of Chamomile on Daytime Functioning Measures: STAI Pre-Treatment State Subscale	33.2 units on a scale Standard Deviation 9.7	30.8 units on a scale Standard Deviation 8.0
Change From Baseline of Chamomile on Daytime Functioning Measures: STAI Post-treatment State Subscale	33.6 units on a scale Standard Deviation 11.0	30.1 units on a scale Standard Deviation 6.8
Change From Baseline of Chamomile on Daytime Functioning Measures: STAI Pre-Treatment Trait Subscale	37.5 units on a scale Standard Deviation 11.3	36.3 units on a scale Standard Deviation 10.1
Change From Baseline of Chamomile on Daytime Functioning Measures: STAI Post-Treatment Trait Subscale	40.8 units on a scale Standard Deviation 15.5	35.5 units on a scale Standard Deviation 11.0

SECONDARY outcome

Timeframe: Baseline and 28 days

Change From Baseline of Chamomile on Daytime Functioning Measures: Fatigue Severity Scale (FSS) Range: 9 to 63. The 9-item scale measures the severity of fatigue and its effect on a person's activities and lifestyle in patients with a variety of disorders. The minimum score = 9 and maximum score possible = 63. Higher the score = greater fatigue severity.

Outcome measures

Outcome measures
Measure	Placebo Tablet n=17 Participants Contained lactose	Chamomile High Grade Extract n=17 Participants Each capsule contains 90 mg dry extract of chamomile flowering tops \[6:1 (v/v) extraction solvent (ethanol 70%/30% water): flowering tops\] standardized up to 2.5 mg of (-)-α-bisabolol and ≥ 2.5 mg of apigenin per tablet
Change From Baseline of Chamomile on Daytime Functioning Measures: Fatigue Severity Scale Pre-Treatment FSS score	30.9 units on a scale Standard Deviation 9.1	32.1 units on a scale Standard Deviation 10.6
Change From Baseline of Chamomile on Daytime Functioning Measures: Fatigue Severity Scale Post-treatment FSS score	32.3 units on a scale Standard Deviation 10.0	27.9 units on a scale Standard Deviation 9.3

SECONDARY outcome

Timeframe: Baseline and 28 days

Population: Before first participants completed the study, the decision was made not to gather this data for reasons of cost.

the change from baseline of global QOL (as determined by the 12 Item Short Form Health Survey Version 2 {SF-12 V2})

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: once per week during study and day 28

Changes from baseline in the safety and tolerability of Chamomile High Grade Extract, three tablets (equivalent to 7.5g of dried herb) p.o. twice times daily versus placebo were measured by counting all participants who reported a serious or non-serious adverse event at the weekly check-ins that were established.

Outcome measures

Outcome measures
Measure	Placebo Tablet n=17 Participants Contained lactose	Chamomile High Grade Extract n=17 Participants Each capsule contains 90 mg dry extract of chamomile flowering tops \[6:1 (v/v) extraction solvent (ethanol 70%/30% water): flowering tops\] standardized up to 2.5 mg of (-)-α-bisabolol and ≥ 2.5 mg of apigenin per tablet
Changes From Baseline in the Safety and Tolerability of Chamomile	10 Participants	6 Participants

Adverse Events

Placebo Tablet

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Chamomile High Grade Extract

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Placebo Tablet n=17 participants at risk Contained lactose	Chamomile High Grade Extract n=17 participants at risk Each capsule contains 90 mg dry extract of chamomile flowering tops \[6:1 (v/v) extraction solvent (ethanol 70%/30% water): flowering tops\] standardized up to 2.5 mg of (-)-α-bisabolol and ≥ 2.5 mg of apigenin per tablet
Infections and infestations Infections	17.6% 3/17	11.8% 2/17
General disorders Headaches	5.9% 1/17	5.9% 1/17
Nervous system disorders Dizziness	5.9% 1/17	0.00% 0/17
Gastrointestinal disorders GI Symptoms	23.5% 4/17	11.8% 2/17
Musculoskeletal and connective tissue disorders Musculoskeletal	11.8% 2/17	5.9% 1/17

Additional Information

Suzanna M Zick

University of Michigan

Phone: 734-998-9553

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place