Condition category
Respiratory
Date applied
20/12/2007
Date assigned
25/01/2008
Last edited
25/01/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Jay Udani

ORCID ID

Contact details

18250 Roscoe Blvd.
Suite 240
Northridge
91325
United States of America

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

BB100A and BB100B

Study information

Scientific title

Acronym

BB100A and BB100B

Study hypothesis

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

Approval received from the Copernicus Group Institutional Review Board (IRB) on the 19th September 2006 (ref: MED4-06-238).

Study design

Randomised double-blind placebo controlled crossover study.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

ALAP-1

Primary outcome measures

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 trial start date

01/09/2006

Overall trial end date

01/04/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age 18 - 59 years, either sex
2. A history of seasonal allergic rhinitis

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

20

Participant 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

Recruitment start date

01/09/2006

Recruitment end date

01/04/2007

Locations

Countries of recruitment

United States of America

Trial participating centre

18250 Roscoe Blvd.
Northridge
91325
United States of America

Sponsor information

Organisation

Radix Bioscience (USA)

Sponsor details

4436 Reeves Road
Ojai
93023
United States of America

Sponsor type

Industry

Website

http://www.radixbioresearch.com/

Funders

Funder type

Industry

Funder name

Radix Bioscience (USA)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes