Trial Outcomes & Findings for Efficacy and Safety of Lymphdiaral Basistropfen (HDC) in the Treatment of Chronic Low-back Pain (NCT NCT01049373)
NCT ID: NCT01049373
Last Updated: 2012-09-06
Results Overview
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)
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
221 participants
Primary outcome timeframe
between screening and 15 weeks treatment
Results posted on
2012-09-06
Participant Flow
hospital, 5.12.2003 - 5.5.2007 (first patient in / last patient out)
screening visit (up to one week before baseline)
Participant milestones
| Measure |
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
|
|---|---|---|
|
Overall Study
STARTED
|
112
|
109
|
|
Overall Study
COMPLETED
|
73
|
65
|
|
Overall Study
NOT COMPLETED
|
39
|
44
|
Reasons for withdrawal
| Measure |
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
|
|---|---|---|
|
Overall Study
Protocol Violation
|
9
|
9
|
|
Overall Study
Withdrawal by Subject
|
8
|
5
|
|
Overall Study
Adverse Event
|
3
|
3
|
|
Overall Study
Lost to Follow-up
|
9
|
4
|
|
Overall Study
no evaluable study values
|
9
|
21
|
|
Overall Study
Other
|
1
|
1
|
|
Overall Study
Non-cooperation
|
0
|
1
|
Baseline Characteristics
Efficacy and Safety of Lymphdiaral Basistropfen (HDC) in the Treatment of Chronic Low-back Pain
Baseline characteristics by cohort
| Measure |
Lymphdiaral Basistropfen (HDC)
n=112 Participants
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
n=109 Participants
10 drops t.i.d. for 15 weeks
|
Total
n=221 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
|
85 Participants
n=5 Participants
|
78 Participants
n=7 Participants
|
163 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
27 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
96 Participants
n=5 Participants
|
97 Participants
n=7 Participants
|
193 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: between screening and 15 weeks treatmentPopulation: ITT
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)
Outcome measures
| Measure |
Lymphdiaral Basistropfen (HDC)
n=103 Participants
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
n=89 Participants
10 drops t.i.d. for 15 weeks
|
|---|---|---|
|
Change in FFbH-R Between Screening and Week 15
|
8.8 units on a scale
Standard Deviation 15.0
|
4.1 units on a scale
Standard Deviation 15.3
|
SECONDARY outcome
Timeframe: between screening and 2 weeks treatmentPopulation: ITT
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)
Outcome measures
| Measure |
Lymphdiaral Basistropfen (HDC)
n=103 Participants
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
n=89 Participants
10 drops t.i.d. for 15 weeks
|
|---|---|---|
|
Change in FFbH-R Between Screening and 2 Weeks
|
3.9 units on a scale
Standard Deviation 12.8
|
0.6 units on a scale
Standard Deviation 12.7
|
SECONDARY outcome
Timeframe: following 2 weeks treatmentPopulation: Only patients with assessable values at present time point were analyzed.
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)
Outcome measures
| Measure |
Lymphdiaral Basistropfen (HDC)
n=99 Participants
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
n=86 Participants
10 drops t.i.d. for 15 weeks
|
|---|---|---|
|
Change in Pain Score (SES), Subscale "Sensoric Pain"
|
-4.2 units on a scale
Standard Deviation 7.5
|
-1.8 units on a scale
Standard Deviation 5.4
|
SECONDARY outcome
Timeframe: following 15 weeks treatmentPopulation: Only patients with assessable values at present time point were analyzed.
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)
Outcome measures
| Measure |
Lymphdiaral Basistropfen (HDC)
n=70 Participants
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
n=62 Participants
10 drops t.i.d. for 15 weeks
|
|---|---|---|
|
Change in Pain Score (SES), Subscale "Sensoric Pain"
|
-5.4 units on a scale
Standard Deviation 6.8
|
-3.9 units on a scale
Standard Deviation 7.3
|
SECONDARY outcome
Timeframe: following 2 weeks treatmentOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: following 15 weeks treatmentOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: following 2 weeks treatmentOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: following 15 weeks treatmentOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: following 2 weeks treatmentOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: following 15 weeks treatmentOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: following 2 weeks treatmentOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: following 15 weeks treatOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: following 15 weeks treatmentOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 15 weeks treatmentOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 15 weeks treatmentOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: within 15 weeks treatmentfrequency of ADR with a probable or possible causal relationship
Outcome measures
| Measure |
Lymphdiaral Basistropfen (HDC)
n=112 Participants
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
n=109 Participants
10 drops t.i.d. for 15 weeks
|
|---|---|---|
|
Number of ADRs
|
8 adverse reactions
|
7 adverse reactions
|
Adverse Events
Lymphdiaral Basistropfen (HDC)
Serious events: 6 serious events
Other events: 43 other events
Deaths: 0 deaths
Placebo Solution
Serious events: 7 serious events
Other events: 39 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Lymphdiaral Basistropfen (HDC)
n=112 participants at risk
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
n=109 participants at risk
10 drops t.i.d. for 15 weeks
|
|---|---|---|
|
Investigations
Athroscopy
|
0.89%
1/112 • Number of events 1 • from 2003-Dec-05 to 2007-May-05
|
0.00%
0/109 • from 2003-Dec-05 to 2007-May-05
|
|
Psychiatric disorders
Depression
|
0.89%
1/112 • Number of events 1 • from 2003-Dec-05 to 2007-May-05
|
0.00%
0/109 • from 2003-Dec-05 to 2007-May-05
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.89%
1/112 • Number of events 1 • from 2003-Dec-05 to 2007-May-05
|
1.8%
2/109 • Number of events 2 • from 2003-Dec-05 to 2007-May-05
|
|
Psychiatric disorders
Mental disoerder due to a general medical condition
|
0.89%
1/112 • Number of events 1 • from 2003-Dec-05 to 2007-May-05
|
0.00%
0/109 • from 2003-Dec-05 to 2007-May-05
|
|
Vascular disorders
Hypertensive crisis
|
0.89%
1/112 • Number of events 1 • from 2003-Dec-05 to 2007-May-05
|
0.00%
0/109 • from 2003-Dec-05 to 2007-May-05
|
|
Musculoskeletal and connective tissue disorders
Fibromyalgia
|
0.89%
1/112 • Number of events 1 • from 2003-Dec-05 to 2007-May-05
|
0.00%
0/109 • from 2003-Dec-05 to 2007-May-05
|
|
Musculoskeletal and connective tissue disorders
Musculosskeletal pain
|
0.00%
0/112 • from 2003-Dec-05 to 2007-May-05
|
0.92%
1/109 • Number of events 1 • from 2003-Dec-05 to 2007-May-05
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm malignant
|
0.00%
0/112 • from 2003-Dec-05 to 2007-May-05
|
0.92%
1/109 • Number of events 1 • from 2003-Dec-05 to 2007-May-05
|
|
Surgical and medical procedures
Knee operation
|
0.00%
0/112 • from 2003-Dec-05 to 2007-May-05
|
0.92%
1/109 • Number of events 1 • from 2003-Dec-05 to 2007-May-05
|
|
Surgical and medical procedures
Intestinal operation
|
0.00%
0/112 • from 2003-Dec-05 to 2007-May-05
|
0.92%
1/109 • Number of events 1 • from 2003-Dec-05 to 2007-May-05
|
|
Nervous system disorders
Post herpetic neuralgia
|
0.00%
0/112 • from 2003-Dec-05 to 2007-May-05
|
0.92%
1/109 • Number of events 1 • from 2003-Dec-05 to 2007-May-05
|
Other adverse events
| Measure |
Lymphdiaral Basistropfen (HDC)
n=112 participants at risk
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
n=109 participants at risk
10 drops t.i.d. for 15 weeks
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.7%
3/112 • Number of events 4 • from 2003-Dec-05 to 2007-May-05
|
4.6%
5/109 • Number of events 5 • from 2003-Dec-05 to 2007-May-05
|
|
Gastrointestinal disorders
Diarrhoea
|
4.5%
5/112 • Number of events 6 • from 2003-Dec-05 to 2007-May-05
|
1.8%
2/109 • Number of events 2 • from 2003-Dec-05 to 2007-May-05
|
|
Nervous system disorders
Dizziness
|
4.5%
5/112 • Number of events 5 • from 2003-Dec-05 to 2007-May-05
|
8.3%
9/109 • Number of events 9 • from 2003-Dec-05 to 2007-May-05
|
|
Skin and subcutaneous tissue disorders
Erythema
|
4.5%
5/112 • Number of events 7 • from 2003-Dec-05 to 2007-May-05
|
1.8%
2/109 • Number of events 2 • from 2003-Dec-05 to 2007-May-05
|
|
Nervous system disorders
Headache
|
18.8%
21/112 • Number of events 25 • from 2003-Dec-05 to 2007-May-05
|
16.5%
18/109 • Number of events 21 • from 2003-Dec-05 to 2007-May-05
|
|
Infections and infestations
Nasopharyngitis
|
4.5%
5/112 • Number of events 5 • from 2003-Dec-05 to 2007-May-05
|
3.7%
4/109 • Number of events 4 • from 2003-Dec-05 to 2007-May-05
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.6%
4/112 • Number of events 4 • from 2003-Dec-05 to 2007-May-05
|
2.8%
3/109 • Number of events 3 • from 2003-Dec-05 to 2007-May-05
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
8.0%
9/112 • Number of events 11 • from 2003-Dec-05 to 2007-May-05
|
5.5%
6/109 • Number of events 8 • from 2003-Dec-05 to 2007-May-05
|
|
Infections and infestations
Urinary tract infection
|
3.6%
4/112 • Number of events 4 • from 2003-Dec-05 to 2007-May-05
|
2.8%
3/109 • Number of events 3 • from 2003-Dec-05 to 2007-May-05
|
Additional Information
Dr. Gabriele Weiss
PASCOE pharmazeutische Präparate GmbH
Phone: 0049/641/7960-0
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60