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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pascoe Pharmazeutische Praeparate GmbH
ClinicalTrials.gov Identifier:
NCT01049373
First received: January 12, 2010
Last updated: August 3, 2012
Last verified: June 2012
History of Changes
Results First Received: May 10, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Low Back Pain
Interventions: Drug: HDC
Drug: Placebo solution

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
hospital, 5.12.2003 – 5.5.2007 (first patient in / last patient out)

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
screening visit (up to one week before baseline)

Reporting Groups
  Description
Lymphdiaral Basistropfen (HDC) 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.
Placebo Solution 10 drops t.i.d. for 15 weeks

Participant Flow:   Overall Study
    Lymphdiaral Basistropfen (HDC)     Placebo Solution  
STARTED     112     109  
COMPLETED     73     65  
NOT COMPLETED     39     44  
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  



  Baseline Characteristics
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Reporting Groups
  Description
Lymphdiaral Basistropfen (HDC) 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.
Placebo Solution 10 drops t.i.d. for 15 weeks
Total Total of all reporting groups

Baseline Measures
    Lymphdiaral Basistropfen (HDC)     Placebo Solution     Total  
Number of Participants  
[units: participants]
 		  112     109     221  
Age  
[units: participants]
 		     
<=18 years     0     0     0  
Between 18 and 65 years     85     78     163  
>=65 years     27     31     58  
Gender  
[units: participants]
 		     
Female     96     97     193  
Male     16     12     28  



  Outcome Measures
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1.  Primary:   Change in FFbH-R Between Screening and Week 15   [ Time Frame: between screening and 15 weeks treatment ]
  Show Outcome Measure 1

2.  Secondary:   Change in FFbH-R Between Screening and 2 Weeks   [ Time Frame: between screening and 2 weeks treatment ]
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3.  Secondary:   Change in Pain Score (SES), Subscale "Sensoric Pain"   [ Time Frame: following 2 weeks treatment ]
  Show Outcome Measure 3

4.  Secondary:   Change in Pain Score (SES), Subscale "Sensoric Pain"   [ Time Frame: following 15 weeks treatment ]
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5.  Secondary:   Number of ADRs   [ Time Frame: within 15 weeks treatment ]
  Show Outcome Measure 5

6.  Secondary:   Change in Strength of Pain (Visual Analog Scale VAS)   [ Time Frame: following 2 weeks treatment ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

7.  Secondary:   Change in Strength of Pain (Visual Analog Scale VAS)   [ Time Frame: following 15 weeks treatment ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

8.  Secondary:   Change in State of Health (BF-S)   [ Time Frame: following 2 weeks treatment ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

9.  Secondary:   Change in State of Health (BF-S)   [ Time Frame: following 15 weeks treatment ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

10.  Secondary:   Change in Oswestry Score   [ Time Frame: following 2 weeks treatment ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

11.  Secondary:   Change in Oswestry Score   [ Time Frame: following 15 weeks treatment ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

12.  Secondary:   Change in Short Form Health Survey 12 Items (SF-12)   [ Time Frame: following 2 weeks treatment ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

13.  Secondary:   Change in Short Form Health Survey 12 Items (SF-12) Ment   [ Time Frame: following 15 weeks treat ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

14.  Secondary:   Correlation of Efficacy With the Constitutional Type of the Patient, Measured by the Hattinger Constitutional Manual (HKM) and the Hattinger Constitutional Questionnaire (HKF)   [ Time Frame: following 15 weeks treatment ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

15.  Secondary:   Amount of Analgesics Used   [ Time Frame: 15 weeks treatment ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

16.  Secondary:   Number of Days With Incapability to Work   [ Time Frame: 15 weeks treatment ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Dr. Gabriele Weiss
Organization: PASCOE pharmazeutische Präparate GmbH
phone: 0049/641/7960-0
e-mail: klinischeforschung@pascoe.de


No publications provided


Responsible Party: Pascoe Pharmazeutische Praeparate GmbH
ClinicalTrials.gov Identifier: NCT01049373     History of Changes
Other Study ID Numbers: PSC144/03, ISRCTN88642122
Study First Received: January 12, 2010
Results First Received: May 10, 2012
Last Updated: August 3, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices