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Trial record 19 of 32 for:    Interleukin-10

Efficacy of 2LALERG (Homeopathic Drug) in Allergic Rhinitis Related to Grass Pollen (LLB-2016-01)

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.
ClinicalTrials.gov Identifier: NCT02690935
Recruitment Status : Completed
First Posted : February 24, 2016
Results First Posted : December 15, 2017
Last Update Posted : December 15, 2017
Sponsor:
Information provided by (Responsible Party):
Labo'Life

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Seasonal Allergy
Interventions Drug: 2LALERG
Drug: Placebo
Enrollment 102
Recruitment Details The first patient was enrolled in the study on 05 March 2016 and the last study visit was on 29 November 2016.
Pre-assignment Details  
Arm/Group Title 2LALERG Placebo
Hide Arm/Group Description

Interleukin 1: 17 CH Interleukin 4: 17–27 CH Interleukin 5: 17 CH Interleukin 6: 17 CH Interleukin 10: 17 CH Interleukin 12: 9 CH Interleukin 13: 17 CH Tumor Necrosis Factor Alpha: 17 CH Transforming Growth Factor Beta: 5 CH Pulmo histaminum: 15 CH SNA-HLA-II: 18 CH

Impregnated on lactose saccharose globules (380 mg/capsule)

2LALERG: Homeopathic drug

Non-impregnated lactose saccharose globules (380 mg/capsule)

Placebo: Placebo

Period Title: Overall Study
Started 51 [1] 51 [1]
Completed 51 [1] 51 [1]
Not Completed 0 0
[1]
Count of participants
Arm/Group Title 2LALERG Placebo Total
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Interleukin 1: 17 CH Interleukin 4: 17–27 CH Interleukin 5: 17 CH Interleukin 6: 17 CH Interleukin 10: 17 CH Interleukin 12: 9 CH Interleukin 13: 17 CH Tumor Necrosis Factor Alpha: 17 CH Transforming Growth Factor Beta: 5 CH Pulmo histaminum: 15 CH SNA-HLA-II: 18 CH

Impregnated on lactose saccharose globules (380 mg/capsule)

2LALERG: Homeopathic drug

Non-impregnated lactose saccharose globules (380 mg/capsule)

Placebo: Placebo

Total of all reporting groups
Overall Number of Baseline Participants 51 51 102
Hide Baseline Analysis Population Description
No difference
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 51 participants 51 participants 102 participants
39.5  (14.5) 40.7  (15.1) 40.1  (14.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 51 participants 51 participants 102 participants
Female
23
  45.1%
26
  51.0%
49
  48.0%
Male
28
  54.9%
25
  49.0%
53
  52.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 51 participants 51 participants 102 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
51
 100.0%
51
 100.0%
102
 100.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Belgium Number Analyzed 51 participants 51 participants 102 participants
51 51 102
1.Primary Outcome
Title Area Under the Curve [AUC](Total Score of Symptoms Taking Into Account the Total 5 Symptom Score (T5SS) and Consumption of Rescue Medications (RM) on the Y-axis, and Time on X Axis)
Hide Description Area under the curve [AUC] (total score of symptoms taking into account the Total 5 Symptom Score (T5SS) and consumption of rescue medications (RM) on the Y-axis versus time on X axis). T5SS was the sum of the 5 individual scores (min-max=0-15). It was corrected each day as a function of consumption of rescue medications (RM): oral antihistamine (+2 points), local treatment (nasal or eye; +1 point), ocular cromoglycate (+1 point) and nasal topical corticosteroids (+1 point). An increase in the total corrected score was considered as a worsening of the allergic symptoms.
Time Frame Up to Month 6 (end of pollen season)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title 2LALERG Placebo
Hide Arm/Group Description:

Interleukin 1: 17 CH Interleukin 4: 17–27 CH Interleukin 5: 17 CH Interleukin 6: 17 CH Interleukin 10: 17 CH Interleukin 12: 9 CH Interleukin 13: 17 CH Tumor Necrosis Factor Alpha: 17 CH Transforming Growth Factor Beta: 5 CH Pulmo histaminum: 15 CH SNA-HLA-II: 18 CH

Impregnated on lactose saccharose globules (380 mg/capsule)

2LALERG: Homeopathic drug

Non-impregnated lactose saccharose globules (380 mg/capsule)

Placebo: Placebo

Overall Number of Participants Analyzed 49 47
Mean (Standard Deviation)
Unit of Measure: T5SS score corrected with RM * day
2.76  (1.89) 2.97  (2.48)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 2LALERG, Placebo
Comments H0: The efficacy of 2LALERG and placebo are similar H1: The efficacy of 2LALERG and placebo are different
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.642
Comments No adjustment of the p-value
Method t-test, 2 sided
Comments [Not Specified]
2.Secondary Outcome
Title Quality of Life During the Whole Period of Observation
Hide Description This is the mean of the score to 3 daily quality of life questions: 1) Did you sleep well (0 to 3), 2) Are you able to work (0 to 3), 3) How do you feel today (0 to 3). The minimum daily score is 0 (good quality of life) and the maximum is 9 (bad quality of life). The mean of the daily scores was calculated over the whole period of observation (up to 6 months) for each patient.
Time Frame QoL scores were assessed daily for up to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title 2LALERG Placebo
Hide Arm/Group Description:

Interleukin 1: 17 CH Interleukin 4: 17–27 CH Interleukin 5: 17 CH Interleukin 6: 17 CH Interleukin 10: 17 CH Interleukin 12: 9 CH Interleukin 13: 17 CH Tumor Necrosis Factor Alpha: 17 CH Transforming Growth Factor Beta: 5 CH Pulmo histaminum: 15 CH SNA-HLA-II: 18 CH

Impregnated on lactose saccharose globules (380 mg/capsule)

2LALERG: Homeopathic drug

Non-impregnated lactose saccharose globules (380 mg/capsule)

Placebo: Placebo

Overall Number of Participants Analyzed 49 47
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.84  (0.88) 0.81  (0.81)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 2LALERG, Placebo
Comments H0: 2LALERG and placebo have the same effect on the quality of life H1: 2LALERG and placebo do not have the same effect on the quality of life
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.829
Comments No adjustment for multiplicity
Method t-test, 2 sided
Comments [Not Specified]
Time Frame 6 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 2LALERG Placebo
Hide Arm/Group Description

Interleukin 1: 17 CH Interleukin 4: 17–27 CH Interleukin 5: 17 CH Interleukin 6: 17 CH Interleukin 10: 17 CH Interleukin 12: 9 CH Interleukin 13: 17 CH Tumor Necrosis Factor Alpha: 17 CH Transforming Growth Factor Beta: 5 CH Pulmo histaminum: 15 CH SNA-HLA-II: 18 CH

Impregnated on lactose saccharose globules (380 mg/capsule)

2LALERG: Homeopathic drug

Non-impregnated lactose saccharose globules (380 mg/capsule)

Placebo: Placebo

All-Cause Mortality
2LALERG Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/51 (0.00%)      0/51 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
2LALERG Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/51 (1.96%)      2/51 (3.92%)    
Cardiac disorders     
Atrial fibrillation * 1  0/51 (0.00%)  0 1/51 (1.96%)  1
Nervous system disorders     
Transient ischemic attack * 1  0/51 (0.00%)  0 1/51 (1.96%)  1
Psychiatric disorders     
Cocaine abuse * 1  1/51 (1.96%)  1 0/51 (0.00%)  0
Renal and urinary disorders     
Nephrolithiasis * 1  0/51 (0.00%)  0 1/51 (1.96%)  1
1
Term from vocabulary, MedDRA (10.0)
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
2LALERG Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   7/51 (13.73%)      7/51 (13.73%)    
Gastrointestinal disorders     
Enteritis * 1  3/51 (5.88%)  3 1/51 (1.96%)  1
Infections and infestations     
Bronchitis * 1  3/51 (5.88%)  3 0/51 (0.00%)  0
Rhinitis * 1  1/51 (1.96%)  1 3/51 (5.88%)  3
Respiratory, thoracic and mediastinal disorders     
Cough * 1  0/51 (0.00%)  0 3/51 (5.88%)  3
1
Term from vocabulary, MedDRA (10.0)
*
Indicates events were collected by non-systematic assessment
  1. Allergy cases were mainly prevalent and chronic.
  2. Many concomitant drugs were taken
  3. Patients were older in this trial compared to Van der Brempt et al. (2011)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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. Stephane Heijmans
Organization: ECSOR
Phone: 3267444093
Responsible Party: Labo'Life
ClinicalTrials.gov Identifier: NCT02690935     History of Changes
Other Study ID Numbers: LLB-2016-01
First Submitted: February 17, 2016
First Posted: February 24, 2016
Results First Submitted: April 7, 2017
Results First Posted: December 15, 2017
Last Update Posted: December 15, 2017