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Trial record 23 of 27 for:    Echinacea

Efficacy and Safety of Lymphdiaral Basistropfen (HDC) in the Treatment of Chronic Low-back Pain (144)

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ClinicalTrials.gov Identifier: NCT01049373
Recruitment Status : Completed
First Posted : January 14, 2010
Results First Posted : September 6, 2012
Last Update Posted : September 6, 2012
Sponsor:
Information provided by (Responsible Party):
Pascoe Pharmazeutische Praeparate GmbH

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Low Back Pain
Interventions Drug: HDC
Drug: Placebo solution
Enrollment 221
Recruitment Details hospital, 5.12.2003 – 5.5.2007 (first patient in / last patient out)
Pre-assignment Details screening visit (up to one week before baseline)
Arm/Group Title Lymphdiaral Basistropfen (HDC) Placebo Solution
Hide Arm/Group Description HDC (Calendula mother tincture, Condurango 2X, Phytolacca 2X, Carduus marianus 1X, Chelidonium 2X, Hydrastis mother tincture, Leptandra mother tincture, Taraxacum mother tincture, Echinacea mother tincture, Lycopodium 2X, Sanguinaria mother tincture and Arsenicum album 8X), each 10 drops t.i.d. for 15 weeks. 10 drops t.i.d. for 15 weeks
Period Title: Overall Study
Started 112 109
Completed 73 65
Not Completed 39 44
Reason Not Completed
Protocol Violation             9             9
Withdrawal by Subject             8             5
Adverse Event             3             3
Lost to Follow-up             9             4
no evaluable study values             9             21
Not specified             1             1
Non-cooperation             0             1
Arm/Group Title Lymphdiaral Basistropfen (HDC) Placebo Solution Total
Hide Arm/Group Description HDC (Calendula mother tincture, Condurango 2X, Phytolacca 2X, Carduus marianus 1X, Chelidonium 2X, Hydrastis mother tincture, Leptandra mother tincture, Taraxacum mother tincture, Echinacea mother tincture, Lycopodium 2X, Sanguinaria mother tincture and Arsenicum album 8X), each 10 drops t.i.d. for 15 weeks. 10 drops t.i.d. for 15 weeks Total of all reporting groups
Overall Number of Baseline Participants 112 109 221
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 112 participants 109 participants 221 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
85
  75.9%
78
  71.6%
163
  73.8%
>=65 years
27
  24.1%
31
  28.4%
58
  26.2%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 112 participants 109 participants 221 participants
Female
96
  85.7%
97
  89.0%
193
  87.3%
Male
16
  14.3%
12
  11.0%
28
  12.7%
1.Primary Outcome
Title Change in FFbH-R Between Screening and Week 15
Hide Description

Hannover Functional Questionnaire (FFbH-R) As used in this study test FFbH-R is a special version of the FFbH "for close to everyday diagnostics of functional impairment by back pain". It is a patient questionnaire, which consists of 12 questions for the acquisition of functional limitations consists in activities of daily living.

Change in FFbH-R between screening and week 15 Scale ranges from 0 (=worst) to 100(=best)

Time Frame between screening and 15 weeks treatment
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Lymphdiaral Basistropfen (HDC) Placebo Solution
Hide Arm/Group Description:
HDC (Calendula mother tincture, Condurango 2X, Phytolacca 2X, Carduus marianus 1X, Chelidonium 2X, Hydrastis mother tincture, Leptandra mother tincture, Taraxacum mother tincture, Echinacea mother tincture, Lycopodium 2X, Sanguinaria mother tincture and Arsenicum album 8X), each 10 drops t.i.d. for 15 weeks.
10 drops t.i.d. for 15 weeks
Overall Number of Participants Analyzed 103 89
Mean (Standard Deviation)
Unit of Measure: units on a scale
8.8  (15.0) 4.1  (15.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lymphdiaral Basistropfen (HDC), Placebo Solution
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0426
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
2.Secondary Outcome
Title Change in FFbH-R Between Screening and 2 Weeks
Hide Description

Hannover Functional Questionnaire (FFbH-R) As used in this study test FFbH-R is a special version of the FFbH "for close to everyday diagnostics of functional impairment by back pain". It is a patient questionnaire, which consists of 12 questions for the acquisition of functional limitations consists in activities of daily living.

Change in FFbH-R between screening and 2 weeks Scale ranges from 0 (=worst) to 100(=best)

Time Frame between screening and 2 weeks treatment
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Lymphdiaral Basistropfen (HDC) Placebo Solution
Hide Arm/Group Description:
HDC (Calendula mother tincture, Condurango 2X, Phytolacca 2X, Carduus marianus 1X, Chelidonium 2X, Hydrastis mother tincture, Leptandra mother tincture, Taraxacum mother tincture, Echinacea mother tincture, Lycopodium 2X, Sanguinaria mother tincture and Arsenicum album 8X), each 10 drops t.i.d. for 15 weeks.
10 drops t.i.d. for 15 weeks
Overall Number of Participants Analyzed 103 89
Mean (Standard Deviation)
Unit of Measure: units on a scale
3.9  (12.8) 0.6  (12.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lymphdiaral Basistropfen (HDC), Placebo Solution
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0757
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
3.Secondary Outcome
Title Change in Pain Score (SES), Subscale "Sensoric Pain"
Hide Description

Pain Perception Scale (SES) The SES is a patient questionnaire, which consists of 24 questions, both the affective (14 questions) and sensoric (10 questions) depict aspects.

Difference between V1 minus V-1 in the subscale "sensoric pain" Scale ranges from 10(=best) to 40(=worst)

Time Frame following 2 weeks treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Only patients with assessable values at present time point were analyzed.
Arm/Group Title LYMPHDIARAL (HDC) Placebo Solution
Hide Arm/Group Description:
HDC (Calendula mother tincture, Condurango 2X, Phytolacca 2X, Carduus marianus 1X, Chelidonium 2X, Hydrastis mother tincture, Leptandra mother tincture, Taraxacum mother tincture, Echinacea mother tincture, Lycopodium 2X, Sanguinaria mother tincture and Arsenicum album 8X), each 10 drops t.i.d. for 15 weeks.
10 drops t.i.d. for 15 weeks
Overall Number of Participants Analyzed 99 86
Mean (Standard Deviation)
Unit of Measure: units on a scale
-4.2  (7.5) -1.8  (5.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LYMPHDIARAL (HDC), Placebo Solution
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0465
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
4.Secondary Outcome
Title Change in Pain Score (SES), Subscale "Sensoric Pain"
Hide Description

Pain Perception Scale (SES) The SES is a patient questionnaire, which consists of 24 questions, both the affective (14 questions) and sensoric (10 questions) depict aspects.

Difference between screening and 15 weeks in the subscale "sensoric pain" Scale ranges from 10(=best) to 40(=worst)

Time Frame following 15 weeks treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Only patients with assessable values at present time point were analyzed.
Arm/Group Title LYMPHDIARAL (HDC) PLACEBO Solution
Hide Arm/Group Description:
HDC (Calendula mother tincture, Condurango 2X, Phytolacca 2X, Carduus marianus 1X, Chelidonium 2X, Hydrastis mother tincture, Leptandra mother tincture, Taraxacum mother tincture, Echinacea mother tincture, Lycopodium 2X, Sanguinaria mother tincture and Arsenicum album 8X), each 10 drops t.i.d. for 15 weeks.
10 drops t.i.d. for 15 weeks
Overall Number of Participants Analyzed 70 62
Mean (Standard Deviation)
Unit of Measure: units on a scale
-5.4  (6.8) -3.9  (7.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LYMPHDIARAL (HDC), PLACEBO Solution
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.04443
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
5.Secondary Outcome
Title Change in Strength of Pain (Visual Analog Scale VAS)
Hide Description [Not Specified]
Time Frame following 2 weeks treatment
Outcome Measure Data Not Reported
6.Secondary Outcome
Title Change in Strength of Pain (Visual Analog Scale VAS)
Hide Description [Not Specified]
Time Frame following 15 weeks treatment
Outcome Measure Data Not Reported
7.Secondary Outcome
Title Change in State of Health (BF-S)
Hide Description [Not Specified]
Time Frame following 2 weeks treatment
Outcome Measure Data Not Reported
8.Secondary Outcome
Title Change in State of Health (BF-S)
Hide Description [Not Specified]
Time Frame following 15 weeks treatment
Outcome Measure Data Not Reported
9.Secondary Outcome
Title Change in Oswestry Score
Hide Description [Not Specified]
Time Frame following 2 weeks treatment
Outcome Measure Data Not Reported
10.Secondary Outcome
Title Change in Oswestry Score
Hide Description [Not Specified]
Time Frame following 15 weeks treatment
Outcome Measure Data Not Reported
11.Secondary Outcome
Title Change in Short Form Health Survey 12 Items (SF-12)
Hide Description [Not Specified]
Time Frame following 2 weeks treatment
Outcome Measure Data Not Reported
12.Secondary Outcome
Title Change in Short Form Health Survey 12 Items (SF-12) Ment
Hide Description [Not Specified]
Time Frame following 15 weeks treat
Outcome Measure Data Not Reported
13.Secondary Outcome
Title Correlation of Efficacy With the Constitutional Type of the Patient, Measured by the Hattinger Constitutional Manual (HKM) and the Hattinger Constitutional Questionnaire (HKF)
Hide Description [Not Specified]
Time Frame following 15 weeks treatment
Outcome Measure Data Not Reported
14.Secondary Outcome
Title Amount of Analgesics Used
Hide Description [Not Specified]
Time Frame 15 weeks treatment
Outcome Measure Data Not Reported
15.Secondary Outcome
Title Number of Days With Incapability to Work
Hide Description [Not Specified]
Time Frame 15 weeks treatment
Outcome Measure Data Not Reported
16.Secondary Outcome
Title Number of ADRs
Hide Description frequency of ADR with a probable or possible causal relationship
Time Frame within 15 weeks treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title LYMPHDIARAL (HDC) Placebo Solution
Hide Arm/Group Description:
HDC (Calendula mother tincture, Condurango 2X, Phytolacca 2X, Carduus marianus 1X, Chelidonium 2X, Hydrastis mother tincture, Leptandra mother tincture, Taraxacum mother tincture, Echinacea mother tincture, Lycopodium 2X, Sanguinaria mother tincture and Arsenicum album 8X), each 10 drops t.i.d. for 15 weeks.
10 drops t.i.d. for 15 weeks
Overall Number of Participants Analyzed 112 109
Measure Type: Number
Unit of Measure: adverse reactions
8 7
Time Frame from 2003-Dec-05 to 2007-May-05
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Lymphdiaral Basistropfen (HDC) Placebo Solution
Hide Arm/Group Description HDC (Calendula mother tincture, Condurango 2X, Phytolacca 2X, Carduus marianus 1X, Chelidonium 2X, Hydrastis mother tincture, Leptandra mother tincture, Taraxacum mother tincture, Echinacea mother tincture, Lycopodium 2X, Sanguinaria mother tincture and Arsenicum album 8X), each 10 drops t.i.d. for 15 weeks. 10 drops t.i.d. for 15 weeks
All-Cause Mortality
Lymphdiaral Basistropfen (HDC) Placebo Solution
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Lymphdiaral Basistropfen (HDC) Placebo Solution
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/112 (5.36%)      7/109 (6.42%)    
Investigations     
Athroscopy  1 [1]  1/112 (0.89%)  1 0/109 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Intervertebral disc protrusion  1 [2]  1/112 (0.89%)  1 2/109 (1.83%)  2
Fibromyalgia  1 [3]  1/112 (0.89%)  1 0/109 (0.00%)  0
Musculosskeletal pain  1 [2]  0/112 (0.00%)  0 1/109 (0.92%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Neoplasm malignant  1 [2]  0/112 (0.00%)  0 1/109 (0.92%)  1
Nervous system disorders     
Post herpetic neuralgia  1 [2]  0/112 (0.00%)  0 1/109 (0.92%)  1
Psychiatric disorders     
Depression  1 [2]  1/112 (0.89%)  1 0/109 (0.00%)  0
Mental disoerder due to a general medical condition  1 [2]  1/112 (0.89%)  1 0/109 (0.00%)  0
Surgical and medical procedures     
Knee operation  1 [2]  0/112 (0.00%)  0 1/109 (0.92%)  1
Intestinal operation  1 [2]  0/112 (0.00%)  0 1/109 (0.92%)  1
Vascular disorders     
Hypertensive crisis  1 [2]  1/112 (0.89%)  1 0/109 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (10.1)
[1]
unlikely
[2]
not related
[3]
possible
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
Lymphdiaral Basistropfen (HDC) Placebo Solution
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   43/112 (38.39%)      39/109 (35.78%)    
Gastrointestinal disorders     
Diarrhoea  1  5/112 (4.46%)  6 2/109 (1.83%)  2
Infections and infestations     
Nasopharyngitis  1  5/112 (4.46%)  5 4/109 (3.67%)  4
Urinary tract infection  1  4/112 (3.57%)  4 3/109 (2.75%)  3
Musculoskeletal and connective tissue disorders     
Arthralgia  1  3/112 (2.68%)  4 5/109 (4.59%)  5
Pain in extremity  1  4/112 (3.57%)  4 3/109 (2.75%)  3
Nervous system disorders     
Dizziness  1  5/112 (4.46%)  5 9/109 (8.26%)  9
Headache  1  21/112 (18.75%)  25 18/109 (16.51%)  21
Skin and subcutaneous tissue disorders     
Erythema  1  5/112 (4.46%)  7 2/109 (1.83%)  2
Pruritus  1  9/112 (8.04%)  11 6/109 (5.50%)  8
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (10.1)
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. Gabriele Weiss
Organization: PASCOE pharmazeutische Präparate GmbH
Phone: 0049/641/7960-0
Responsible Party: Pascoe Pharmazeutische Praeparate GmbH
ClinicalTrials.gov Identifier: NCT01049373     History of Changes
Other Study ID Numbers: PSC144/03
ISRCTN88642122 ( Registry Identifier: ISRCTN )
First Submitted: January 12, 2010
First Posted: January 14, 2010
Results First Submitted: May 10, 2012
Results First Posted: September 6, 2012
Last Update Posted: September 6, 2012