Trial Outcomes & Findings for Homeopathic Cold Remedy for Children Study (NCT NCT01257503)

Results Overview

Parents measured change in runny nose, cough, nasal congestion and sneezing severity one hour after administering a dose of study medication up to the first 10 doses of study medication. Change in symptom rated from 0 to 6, with 0 indicative of the symptom being much worse and 6 indicative of the symptom being much improved. The unit of analysis for each outcome was doses of medication. Each participant could contribute data on 0 - 10 doses.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

263 participants

Primary outcome timeframe

Parents assessed change in symptom 1 hour after a dose of study medication

Results posted on

2015-01-14

Participant Flow

Participant milestones

Participant milestones
Measure	Homeopathic Cold Remedy 5 ml of homeopathic cold remedy given by mouth up to 6 times per day as needed for cold symptoms Hyland's Cold 'n Cough 4 kids: 5 ml PO q4h prn cold symptoms	Placebo 5 ml of placebo given by mouth up to 6 times per day as needed for cold symptoms placebo: liquid made to look like the active homeopathic remedy
Overall Study STARTED	133	130
Overall Study Returned Symptom Diaries	80	83
Overall Study Returned Dosage Logbooks	75	80
Overall Study COMPLETED	125	119
Overall Study NOT COMPLETED	8	11

Reasons for withdrawal

Reasons for withdrawal
Measure	Homeopathic Cold Remedy 5 ml of homeopathic cold remedy given by mouth up to 6 times per day as needed for cold symptoms Hyland's Cold 'n Cough 4 kids: 5 ml PO q4h prn cold symptoms	Placebo 5 ml of placebo given by mouth up to 6 times per day as needed for cold symptoms placebo: liquid made to look like the active homeopathic remedy
Overall Study Lost to Follow-up	7	10
Overall Study Over 5 years old at enrollment	0	1
Overall Study strep culture positive at enrollment	1	0

Baseline Characteristics

Homeopathic Cold Remedy for Children Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Homeopathic Cold Remedy n=132 Participants 5 ml of homeopathic cold remedy given by mouth up to 6 times per day as needed for cold symptoms Hyland's Cold 'n Cough 4 kids: 5 ml PO q4h prn cold symptoms	Placebo n=129 Participants 5 ml of placebo given by mouth up to 6 times per day as needed for cold symptoms placebo: liquid made to look like the active homeopathic remedy	Total n=261 Participants Total of all reporting groups
Age, Categorical <=18 years	132 Participants n=5 Participants	129 Participants n=7 Participants	261 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 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	3.4 years STANDARD_DEVIATION 1.1 • n=5 Participants	3.5 years STANDARD_DEVIATION 1.1 • n=7 Participants	3.5 years STANDARD_DEVIATION 1.1 • n=5 Participants
Gender Female	64 participants n=5 Participants	62 participants n=7 Participants	126 participants n=5 Participants
Gender Male	67 participants n=5 Participants	67 participants n=7 Participants	134 participants n=5 Participants
Region of Enrollment United States	132 participants n=5 Participants	129 participants n=7 Participants	261 participants n=5 Participants
baseline cold symptom score	5.4 units on a scale STANDARD_DEVIATION 1.8 • n=5 Participants	5.2 units on a scale STANDARD_DEVIATION 1.8 • n=7 Participants	5.3 units on a scale STANDARD_DEVIATION 1.8 • n=5 Participants

PRIMARY outcome

Timeframe: Parents assessed change in symptom 1 hour after a dose of study medication

Population: Data are from logbooks returned by participants. For each participant, data on response to up to 10 doses were collected. Not every symptom was present at each dose. Change in runny nose assessed after 819 doses, sneeze 456 doses, cough 772 doses, congestion 845. For category title, first n= homeopathic cold remedy, second n= placebo.

Parents measured change in runny nose, cough, nasal congestion and sneezing severity one hour after administering a dose of study medication up to the first 10 doses of study medication. Change in symptom rated from 0 to 6, with 0 indicative of the symptom being much worse and 6 indicative of the symptom being much improved. The unit of analysis for each outcome was doses of medication. Each participant could contribute data on 0 - 10 doses.

Outcome measures

Outcome measures
Measure	Homeopathic Cold Remedy n=502 doses 5 ml of homeopathic cold remedy given by mouth up to 6 times per day as needed for cold symptoms Hyland's Cold 'n Cough 4 kids: 5 ml PO q4h prn cold symptoms	Placebo n=480 doses 5 ml of placebo given by mouth up to 6 times per day as needed for cold symptoms placebo: liquid made to look like the active homeopathic remedy
Change in Severity of Cold Symptoms cough (n=399, 373)	3.8 units on a scale Standard Deviation 1.2	3.8 units on a scale Standard Deviation 1.2
Change in Severity of Cold Symptoms runny nose (n=433, 386)	3.7 units on a scale Standard Deviation 1.3	3.7 units on a scale Standard Deviation 1.0
Change in Severity of Cold Symptoms sneeze (n=219, 237)	3.9 units on a scale Standard Deviation 1.2	3.9 units on a scale Standard Deviation 1.2
Change in Severity of Cold Symptoms congestion (n=409, 436)	3.8 units on a scale Standard Deviation 1.1	3.7 units on a scale Standard Deviation 1.0

SECONDARY outcome

Timeframe: Parents assessed change in symptom 1 hour after dose of study medication

Population: Data are from logbooks returned by participants. For each participant, data on response to up to 10 doses were collected. Not every symptom was present at each dose. Change in irritability assessed after 510 doses, lethargy 414, fussiness 501, appetite 618. For category title, first n= homeopathic cold remedy, second n= placebo.

Parents measured change in severity of irritability, lethargy, fussiness, and appetite one hour after administering a dose of study medication up to the first 10 doses of study medication. Change in symptom rated from 0 to 6, with 0 indicative of the symptom being much worse and 6 indicative of the symptom being much improved. The unit of analysis for each outcome was doses of medication. Each participant could contribute data on 0 - 10 doses.

Outcome measures

Outcome measures
Measure	Homeopathic Cold Remedy n=502 doses 5 ml of homeopathic cold remedy given by mouth up to 6 times per day as needed for cold symptoms Hyland's Cold 'n Cough 4 kids: 5 ml PO q4h prn cold symptoms	Placebo n=480 doses 5 ml of placebo given by mouth up to 6 times per day as needed for cold symptoms placebo: liquid made to look like the active homeopathic remedy
Change in Non-specific Symptoms fussiness (n=262, 239)	3.6 units on a scale Standard Deviation 1.2	3.5 units on a scale Standard Deviation 1.2
Change in Non-specific Symptoms appetite (n=312, 306)	3.6 units on a scale Standard Deviation 1.0	3.5 units on a scale Standard Deviation 1.1
Change in Non-specific Symptoms irritability (n= 272, 238)	3.6 units on a scale Standard Deviation 1.1	3.5 units on a scale Standard Deviation 1.2
Change in Non-specific Symptoms lethargy (n=213, 201)	3.6 units on a scale Standard Deviation 1.1	3.6 units on a scale Standard Deviation 1.1

SECONDARY outcome

Timeframe: 10 days

Population: Participants who completed follow-up and had valid data for functional outcome. Data on functional status analyzed on days 1-3 for participants who returned symptom diaries including 145 on day 1, 142 on day 2 and 130 on day 3. For category title, first n= homeopathic cold remedy, second n= placebo.

Change in functional status of child during the 7-10 days after the index visit for an upper respiratory tract infection. Parents rated 5 activities (vigorous activity, activities that require concentration, activities with family or friends, appetite and sleep) daily for 3 days in their child and again at the 7-10 day follow-up. Functional status scores range from 0 to 15, with higher scores indicative of better functional status.

Outcome measures

Outcome measures
Measure	Homeopathic Cold Remedy n=123 Participants 5 ml of homeopathic cold remedy given by mouth up to 6 times per day as needed for cold symptoms Hyland's Cold 'n Cough 4 kids: 5 ml PO q4h prn cold symptoms	Placebo n=117 Participants 5 ml of placebo given by mouth up to 6 times per day as needed for cold symptoms placebo: liquid made to look like the active homeopathic remedy
Functional Status functional status day 1 (n=68, 77)	11.0 units on a scale Standard Deviation 3.5	10.4 units on a scale Standard Deviation 3.1
Functional Status functional status day 2 (n=72, 70)	11.7 units on a scale Standard Deviation 3.4	11.8 units on a scale Standard Deviation 3.4
Functional Status functional status day 3 (n= 62, 68)	12.7 units on a scale Standard Deviation 3.0	12.5 units on a scale Standard Deviation 3.0
Functional Status functional status at follow-up (n=123, 117)	14.2 units on a scale Standard Deviation 1.7	13.7 units on a scale Standard Deviation 2.7

SECONDARY outcome

Timeframe: 10 days

Population: Health status on those with follow-up data and a valid score for health status. Health status also assessed in participants who returned symptom diaries including 152 on day 1, 142 on day 2 and 132 on day 3. For category title, first n= homeopathic cold remedy, second n= placebo.

Change in health status of child during the 7-10 days after the index visit for an upper respiratory tract infection. Parents rated health status on 1-10 scale with 1 indicating perfect health and 10 indicating very sick. Health status rated on first 3 days of study and again at the 7-10 day follow-up

Outcome measures

Outcome measures
Measure	Homeopathic Cold Remedy n=125 Participants 5 ml of homeopathic cold remedy given by mouth up to 6 times per day as needed for cold symptoms Hyland's Cold 'n Cough 4 kids: 5 ml PO q4h prn cold symptoms	Placebo n=117 Participants 5 ml of placebo given by mouth up to 6 times per day as needed for cold symptoms placebo: liquid made to look like the active homeopathic remedy
Health Status health status day 1 (n=75, 77)	4.4 units on a scale Standard Deviation 1.9	4.9 units on a scale Standard Deviation 2.0
Health Status health status day 2 (n=72,70)	3.8 units on a scale Standard Deviation 1.9	4.1 units on a scale Standard Deviation 1.8
Health Status health status day 3 (n=63, 69)	3.2 units on a scale Standard Deviation 2.0	3.4 units on a scale Standard Deviation 1.7
Health Status health status at follow-up (n=125, 117)	2.5 units on a scale Standard Deviation 1.7	2.5 units on a scale Standard Deviation 1.6

SECONDARY outcome

Timeframe: 10 days

Population: Data analyzed on participant who completed 7-10 day follow-up and had valid cold scores. Data also analyzed twice daily on those participants who returned symptom diaries including: day 1 (153, 148), day 2 (146,138), and day 3 (136, 126). For category title, first n= homeopathic cold remedy, second n= placebo.

Change in cold symptoms of child during the 7-10 days after the index visit for an upper respiratory tract infection. Parents assessed severity of runny nose, cough, sneeze and congestion in their child using a 0-3 scale for each symptom, 0=none to 3= severe. Cold score is sum of scores for each symptom. Parents assessed cold score twice daily on study days 1-3 and at the 7-10 day follow-up

Outcome measures

Outcome measures
Measure	Homeopathic Cold Remedy n=123 Participants 5 ml of homeopathic cold remedy given by mouth up to 6 times per day as needed for cold symptoms Hyland's Cold 'n Cough 4 kids: 5 ml PO q4h prn cold symptoms	Placebo n=117 Participants 5 ml of placebo given by mouth up to 6 times per day as needed for cold symptoms placebo: liquid made to look like the active homeopathic remedy
Overall Symptom Severity day 1 assessment 1 (n=73, 80)	4.6 units on a scale Standard Deviation 2.2	5.5 units on a scale Standard Deviation 2.3
Overall Symptom Severity day 1 assessment 2 (n=72, 76)	4.2 units on a scale Standard Deviation 2.4	5.0 units on a scale Standard Deviation 2.0
Overall Symptom Severity day 2 assessment 1 (n=73, 73)	3.7 units on a scale Standard Deviation 2.2	4.0 units on a scale Standard Deviation 2.0
Overall Symptom Severity day 2 assessment 2 (n=69, 69)	3.4 units on a scale Standard Deviation 2.3	4.0 units on a scale Standard Deviation 2.2
Overall Symptom Severity day 3 assessment 1 (n=68, 68)	3.0 units on a scale Standard Deviation 2.5	3.0 units on a scale Standard Deviation 2.3
Overall Symptom Severity day 3 assessment 2 (n= 60, 66)	2.8 units on a scale Standard Deviation 2.5	3.0 units on a scale Standard Deviation 2.3
Overall Symptom Severity follow-up (n= 123, 117)	2.4 units on a scale Standard Deviation 2.6	2.0 units on a scale Standard Deviation 2.0

Adverse Events

Homeopathic Cold Remedy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

James A Taylor

University of Washington

Phone: 206-616-1206

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60