ALAP-1 for the attenuation of nasal provocation with histamine in seasonal allergic rhinitis: a randomised, double-blind, placebo-controlled, three-day dosing, cross-over study and dose finding one month cross-over study
| ISRCTN | ISRCTN83077547 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN83077547 |
| Secondary identifying numbers | BB100A and BB100B |
- Submission date
- 20/12/2007
- Registration date
- 25/01/2008
- Last edited
- 25/01/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Jay Udani
Scientific
Scientific
18250 Roscoe Blvd.
Suite 240
Northridge
91325
United States of America
Study information
| Study design | Randomised double-blind placebo controlled crossover study. |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study acronym | BB100A and BB100B |
| Study objectives | 1. To evaluate the ability of ALAP-1 compared with placebo to reduce the signs and symptoms of allergic rhinitis (AR) in the presence of a nasal histamine challenge 2. To evaluate the efficacy of chronic dosing of ALAP-1 compared with placebo on reducing the symptoms of AR induced by nasal histamine challenge |
| Ethics approval(s) | Approval received from the Copernicus Group Institutional Review Board (IRB) on the 19th September 2006 (ref: MED4-06-238). |
| Health condition(s) or problem(s) studied | Seasonal allergic rhinitis |
| Intervention | ALAP-1 (herbal combination) versus placebo. ALAP-1 is an herbal combination formulated to prevent and reduce AR symptoms. This proprietary formula is a standardised blend of the following eleven botanical extracts: Cullen corylifolium (Psoralea fruit), Xanthium sibiricum (Xanthium fruit), Scutellaria baicalensis (Chinese skullcap root), Gardenia augusta (Gardenia fruit), Bupleurum chinense (Bupleurum root), Chrysanthemum x moriflolium (Chrysanthemum flower), Areca catechu (Areca husk), Schisandra spp. (Schisandra fruit), Ziziphus jujuba var. spinosa (Jujube seed), Nepeta tenuifolia (Schizonepeta aerial parts) and Plantago asiatica (Asian plantain seed). Three-day study: Subjects will consume three capsules of ALAP-1 (1350 mg) or placebo per day for two days and return to the research office on the third day for evaluation. Subjects undergo their baseline peak nasal inspiratory flow (PNIF) measurement and then consume four capsules of ALAP-1 (1800 mg) or placebo. Fifteen minutes later, the nasal histamine provocation is performed. Shortly after the histamine challenge, subjects consume an additional 4 capsules of ALAP-1 (1800 mg) or placebo. This dosing regimen simulates the method in which the formula would be used in practice: daily preventive doses during allergy season and a treatment dose in the event of direct exposure to an environmental allergen. Subjects then wash out for 1 week and are then enrolled into the opposite arm (active or placebo). One month study: Subjects will receive ALAP-1 or placebo for 4 weeks total. Initally, ALAP-1 (or placebo) is provided for 2 weeks at a high dose (1350 mg/day) and subjects undergo nasal histamine provocation and peak nasal inspiratory flow (PNIF) measurements. Then subjects are given ALAP-1 or placebo for 2 weeks at a low dose (900 mg/day). Subjects washout for 1 week and then are enrolled in the opposite arm. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | ALAP-1 |
| Primary outcome measure | Peak nasal inspiratory flow meter, measured at 0, 10, 20, 30, 45 and 60 minutes post-histamine challenge on the study visit days. |
| Secondary outcome measures | Sneeze score, measured at 0, 10, 20, 30, 45 and 60 minutes post-histamine challenge on the study visit days. |
| Overall study start date | 01/09/2006 |
| Completion date | 01/04/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 20 |
| Key inclusion criteria | 1. Age 18 - 59 years, either sex 2. A history of seasonal allergic rhinitis |
| Key exclusion criteria | 1. Atrophic rhinitis 2. Rhinitis medicamentosa 3. Nasal polyps 4. Septal deviation 5. Active bacterial or viral sinusitis 6. Severe asthma 7. Peptic ulcer disease or active gastroesophageal reflux disease (GERD) 8. History of anaphylaxis to any allergen 9. Pregnancy 10. Active bacterial or viral rhinitis 11. Nasal surgery within the last eight weeks |
| Date of first enrolment | 01/09/2006 |
| Date of final enrolment | 01/04/2007 |
Locations
Countries of recruitment
- United States of America
Study participating centre
18250 Roscoe Blvd.
Northridge
91325
United States of America
91325
United States of America
Sponsor information
Radix Bioscience (USA)
Industry
Industry
4436 Reeves Road
Ojai
93023
United States of America
| Website | http://www.radixbioresearch.com/ |
|---|---|
"ROR" |
https://ror.org/024hp8310 |
Funders
Funder type
Industry
Radix Bioscience (USA)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
