A Phase 2 interventional study of Shi-Bi-Lin and Placebo in Perennial Allergic Rhinitis, sponsored by Chinese University of Hong Kong. Completed at 2 sites in Hong Kong. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2010-01-06.
Sponsored by Chinese University of Hong Kong · Phase 2, Interventional, and Treatment
Allergic rhinitis(AR) is one of the most common allergic disorders throughout the world.The conventional therapies are effective in alleviating symptoms but the efficacy are limited and not persistent. Furthermonre, the cost and side-effect are known defects. A classical Chinese herbal formula, has been used for AR for centries. Our study purpose is to evaluate the clinical efficacy and safety of this formula verus placebo in perennial allergic rhinitis (PAR).
Hypothesis: the classical herbal formula would improve the symptoms of PAR patients and change some immunological parameters in the peripheral blood when comparing with the placebo.
It is a randomized, double-blind, placebo-controlled trial.
1,105 studies on the registry are indexed under Rhinitis; 65 are open to participants now.
This study's enrollment of 126 is above the median of 89 across 906 interventional studies indexed under Rhinitis.
Browse Rhinitis studies →Chinese University of Hong Kong is the lead sponsor of 1,419 studies on the registry; 487 are open to participants now.
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Exclusion Criteria:
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).
Drug: Shi-Bi-Lin
The placebo contained brown colored starch resembling the SBL powder
Other: Placebo
4 weeks of treatment, dose of 1 g (two capsules), twice daily
Also known as: Modified from the classic formula Cang-Er-Zi-San.
4 weeks of colormatched placebo capsules, dose of 1 g (two capsules), twice daily
Allergic Rhinitis Symptom Score Including Rhinorrhea, Nasal Obstruction, Sneezing, Itchy Nose and Itchy Eyes at Week 4
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.
Time frame: 4 week
Quality of Life (Difference Between Baseline and Week 4)
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).
Time frame: 4 week
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.
| Milestone | Shi-Bi-Lin | Placebo |
|---|---|---|
| Started | 63 | 63 |
| Completed | 61 | 62 |
| Not completed | 2 | 1 |
| Withdrew: Lost to follow-up | 2 | 1 |
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.
| Unit Score | Shi-Bi-Lin | Placebo |
|---|---|---|
| General Health | 2.82 ± 0.8 | 2.8 ± 0.78 |
| Nose Blockage | 1.19 ± 0.68 | 1.21 ± 0.77 |
| Rhinorrhea volume | 1.26 ± 0.71 | 1.24 ± 0.7 |
| Sneeze Frequency | 1.15 ± 0.64 | 1.18 ± 0.70 |
| Nose Itching | 1.11 ± 0.58 | 0.99 ± 0.75 |
| Eyes Itching | 0.73 ± 0.67 | 0.56 ± 0.76 |
| Tears | 0.52 ± 0.71 | 0.43 ± 0.67 |
| Eye Congestion | 0.37 ± 0.6 | 0.26 ± 0.58 |
| Ear itching | 0.81 ± 0.65 | 0.61 ± 0.78 |
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).
| Unit Score | Shi-Bi-Lin | Placebo |
|---|---|---|
| Physical functioning | 4 ± 14 | 0 ± 10 |
| Role limitation by physical problem | 7 ± 33 | 3 ± 30 |
| Bodily pain | -3 ± 25 | -10 ± 21 |
| General Health | -7 ± 20 | -9 ± 23 |
| Vitality | 8 ± 22 | 13 ± 20 |
| Socail functioning | 17 ± 18 | 17 ± 19 |
| Role limitation by emotional problem | 13 ± 29 | 3 ± 28 |
| Mental health | 1 ± 23 | 1 ± 18 |
Collected over During the 4 week Follow up visit, clients may report any Adverse Event they experience.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Shi-Bi-Lin | — | 0/63 (0%) | 0/63 (0%) |
| Placebo | — | 0/63 (0%) | 0/63 (0%) |
| Age Continuous(Year) | Shi-Bi-Lin | Placebo | Total |
|---|---|---|---|
| Age | 41.19 ± 12.38 | 36.02 ± 11.14 | 38.60 ± 12.01 |
| Sex: Female, Male(Participants) | Shi-Bi-Lin | Placebo | Total |
|---|---|---|---|
| Female | 40 | 43 | 83 |
| Male | 23 | 20 | 43 |
| Region of Enrollment(participants) | Shi-Bi-Lin | Placebo | Total |
|---|---|---|---|
| Hong Kong | 63 | 63 | 126 |
This study is completed, as verified in Nov 2009. You cannot join it, but the record below documents what was studied.
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Chinese University of Hong Kong