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Trial Outcomes & Findings for Herbal Treatment for Perennial Allergic Rhinitis (NCT NCT00456755)

NCT ID: NCT00456755

Last Updated: 2010-01-06

Results Overview

The severity of PAR was evaluated by means of a daily symptom diary chart. Patients were instructed to grade retrospectively everyday before bedtime, their generalwell-being, nasalsymptoms (nasal blockage, rhinorrhea, nose itching, sneezing) and non-nasal symptoms(itching eyes, tearing eyes, redness of eyes, itching of ears or palate) on the diary chart. A 4-point severity scale from no symptoms (0), mild (1), moderated (2) to severe (3) was used.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

126 participants

Primary outcome timeframe

4 week

Results posted on

2010-01-06

Participant Flow

Recruitment started at Jan 2004. Patients were recruited as volunteers from the Prince of Wales hospital, the Yan Chai hospital and the Alice Ho Mui Ling Nethersole Hospital specialist clinics.

Confirmed perennial allergic rhinitis and have a positive skin test to house-dust mite, mold antigens and/or animal dander was required. Enter 1-week run-in-period, during which symptom diary was given to each subject for the evaluation of symptoms. Eligible case with total score higher than 4.

Participant milestones

Participant milestones
Measure
Shi-Bi-Lin
Consist of 6 herbal. 7.5 g Xanthium sibiricum Patrin ex Widder (Asteraceae, Fructus), 20 g Angelica dahurica (Fisch. ex Hoffm.) Benth. (Apiaceae, Radix), 7.5 g Saposhnikovia divaricata (Turcz.) Schischk. (Apiaceae, Radix),15 g Magnolia biondii Pamp., (Magnoliaceae, Flos), 5 g Gentiana scabra Bunge (Gentianaceae, Radix) and 5 g Verbena officinalis L. (Verbenaceae, Herba).
Placebo
The placebo contained brown colored starch resembling the SBL powder
Overall Study
STARTED
63
63
Overall Study
COMPLETED
61
62
Overall Study
NOT COMPLETED
2
1

Reasons for withdrawal

Reasons for withdrawal
Measure
Shi-Bi-Lin
Consist of 6 herbal. 7.5 g Xanthium sibiricum Patrin ex Widder (Asteraceae, Fructus), 20 g Angelica dahurica (Fisch. ex Hoffm.) Benth. (Apiaceae, Radix), 7.5 g Saposhnikovia divaricata (Turcz.) Schischk. (Apiaceae, Radix),15 g Magnolia biondii Pamp., (Magnoliaceae, Flos), 5 g Gentiana scabra Bunge (Gentianaceae, Radix) and 5 g Verbena officinalis L. (Verbenaceae, Herba).
Placebo
The placebo contained brown colored starch resembling the SBL powder
Overall Study
Lost to Follow-up
2
1

Baseline Characteristics

Herbal Treatment for Perennial Allergic Rhinitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Shi-Bi-Lin
n=63 Participants
Consist of 6 herbal. 7.5 g Xanthium sibiricum Patrin ex Widder (Asteraceae, Fructus), 20 g Angelica dahurica (Fisch. ex Hoffm.) Benth. (Apiaceae, Radix), 7.5 g Saposhnikovia divaricata (Turcz.) Schischk. (Apiaceae, Radix),15 g Magnolia biondii Pamp., (Magnoliaceae, Flos), 5 g Gentiana scabra Bunge (Gentianaceae, Radix) and 5 g Verbena officinalis L. (Verbenaceae, Herba).
Placebo
n=63 Participants
The placebo contained brown colored starch resembling the SBL powder
Total
n=126 Participants
Total of all reporting groups
Age Continuous
Age
41.19 Year
STANDARD_DEVIATION 12.38 • n=5 Participants
36.02 Year
STANDARD_DEVIATION 11.14 • n=7 Participants
38.60 Year
STANDARD_DEVIATION 12.01 • n=5 Participants
Sex: Female, Male
Female
40 Participants
n=5 Participants
43 Participants
n=7 Participants
83 Participants
n=5 Participants
Sex: Female, Male
Male
23 Participants
n=5 Participants
20 Participants
n=7 Participants
43 Participants
n=5 Participants
Region of Enrollment
Hong Kong
63 participants
n=5 Participants
63 participants
n=7 Participants
126 participants
n=5 Participants

PRIMARY outcome

Timeframe: 4 week

The severity of PAR was evaluated by means of a daily symptom diary chart. Patients were instructed to grade retrospectively everyday before bedtime, their generalwell-being, nasalsymptoms (nasal blockage, rhinorrhea, nose itching, sneezing) and non-nasal symptoms(itching eyes, tearing eyes, redness of eyes, itching of ears or palate) on the diary chart. A 4-point severity scale from no symptoms (0), mild (1), moderated (2) to severe (3) was used.

Outcome measures

Outcome measures
Measure
Shi-Bi-Lin
n=63 Participants
Consist of 6 herbal. 7.5 g Xanthium sibiricum Patrin ex Widder (Asteraceae, Fructus), 20 g Angelica dahurica (Fisch. ex Hoffm.) Benth. (Apiaceae, Radix), 7.5 g Saposhnikovia divaricata (Turcz.) Schischk. (Apiaceae, Radix),15 g Magnolia biondii Pamp., (Magnoliaceae, Flos), 5 g Gentiana scabra Bunge (Gentianaceae, Radix) and 5 g Verbena officinalis L. (Verbenaceae, Herba).
Placebo
n=63 Participants
The placebo contained brown colored starch resembling the SBL powder
Allergic Rhinitis Symptom Score Including Rhinorrhea, Nasal Obstruction, Sneezing, Itchy Nose and Itchy Eyes at Week 4
Nose Itching
1.11 Unit Score
Standard Deviation 0.58
0.99 Unit Score
Standard Deviation 0.75
Allergic Rhinitis Symptom Score Including Rhinorrhea, Nasal Obstruction, Sneezing, Itchy Nose and Itchy Eyes at Week 4
Eyes Itching
0.73 Unit Score
Standard Deviation 0.67
0.56 Unit Score
Standard Deviation 0.76
Allergic Rhinitis Symptom Score Including Rhinorrhea, Nasal Obstruction, Sneezing, Itchy Nose and Itchy Eyes at Week 4
Tears
0.52 Unit Score
Standard Deviation 0.71
0.43 Unit Score
Standard Deviation 0.67
Allergic Rhinitis Symptom Score Including Rhinorrhea, Nasal Obstruction, Sneezing, Itchy Nose and Itchy Eyes at Week 4
General Health
2.82 Unit Score
Standard Deviation 0.8
2.8 Unit Score
Standard Deviation 0.78
Allergic Rhinitis Symptom Score Including Rhinorrhea, Nasal Obstruction, Sneezing, Itchy Nose and Itchy Eyes at Week 4
Nose Blockage
1.19 Unit Score
Standard Deviation 0.68
1.21 Unit Score
Standard Deviation 0.77
Allergic Rhinitis Symptom Score Including Rhinorrhea, Nasal Obstruction, Sneezing, Itchy Nose and Itchy Eyes at Week 4
Rhinorrhea volume
1.26 Unit Score
Standard Deviation 0.71
1.24 Unit Score
Standard Deviation 0.7
Allergic Rhinitis Symptom Score Including Rhinorrhea, Nasal Obstruction, Sneezing, Itchy Nose and Itchy Eyes at Week 4
Sneeze Frequency
1.15 Unit Score
Standard Deviation 0.64
1.18 Unit Score
Standard Deviation 0.70
Allergic Rhinitis Symptom Score Including Rhinorrhea, Nasal Obstruction, Sneezing, Itchy Nose and Itchy Eyes at Week 4
Eye Congestion
0.37 Unit Score
Standard Deviation 0.6
0.26 Unit Score
Standard Deviation 0.58
Allergic Rhinitis Symptom Score Including Rhinorrhea, Nasal Obstruction, Sneezing, Itchy Nose and Itchy Eyes at Week 4
Ear itching
0.81 Unit Score
Standard Deviation 0.65
0.61 Unit Score
Standard Deviation 0.78

SECONDARY outcome

Timeframe: 4 week

Population: ITT

SF-36 QOL questionnaire administrated before and after treatment. It has eight domains: general health (GH), physical functioning (PF), social functioning (SF), role limitation caused by physical problems (RP), bodily pain (BP), role limitations caused by emotional problem (RE), mental health (MH), and vitality (VT). Each domain was started from 0 (worst health) to 100 (best health).

Outcome measures

Outcome measures
Measure
Shi-Bi-Lin
n=63 Participants
Consist of 6 herbal. 7.5 g Xanthium sibiricum Patrin ex Widder (Asteraceae, Fructus), 20 g Angelica dahurica (Fisch. ex Hoffm.) Benth. (Apiaceae, Radix), 7.5 g Saposhnikovia divaricata (Turcz.) Schischk. (Apiaceae, Radix),15 g Magnolia biondii Pamp., (Magnoliaceae, Flos), 5 g Gentiana scabra Bunge (Gentianaceae, Radix) and 5 g Verbena officinalis L. (Verbenaceae, Herba).
Placebo
n=63 Participants
The placebo contained brown colored starch resembling the SBL powder
Quality of Life (Difference Between Baseline and Week 4)
Physical functioning
4 Unit Score
Standard Deviation 14
0 Unit Score
Standard Deviation 10
Quality of Life (Difference Between Baseline and Week 4)
Role limitation by physical problem
7 Unit Score
Standard Deviation 33
3 Unit Score
Standard Deviation 30
Quality of Life (Difference Between Baseline and Week 4)
Bodily pain
-3 Unit Score
Standard Deviation 25
-10 Unit Score
Standard Deviation 21
Quality of Life (Difference Between Baseline and Week 4)
General Health
-7 Unit Score
Standard Deviation 20
-9 Unit Score
Standard Deviation 23
Quality of Life (Difference Between Baseline and Week 4)
Vitality
8 Unit Score
Standard Deviation 22
13 Unit Score
Standard Deviation 20
Quality of Life (Difference Between Baseline and Week 4)
Socail functioning
17 Unit Score
Standard Deviation 18
17 Unit Score
Standard Deviation 19
Quality of Life (Difference Between Baseline and Week 4)
Role limitation by emotional problem
13 Unit Score
Standard Deviation 29
3 Unit Score
Standard Deviation 28
Quality of Life (Difference Between Baseline and Week 4)
Mental health
1 Unit Score
Standard Deviation 23
1 Unit Score
Standard Deviation 18

Adverse Events

Shi-Bi-Lin

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

Zhao Yu

Department of Otorhinolaryngology, Head & Neck Surgery, West China Hospital, Sichuan University, China

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place