Effects of Pine Cone Extract on Serum IgE Levels in Perennial Rhinitis

NCT04024033 | Unknown DMC

• 1 other identifier: Pine Cone Extract
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

The medicinal properties of pinecones have been used for years to treat a variety of illnesses. In the mouse model, an extract of pine cones, poly-phenylpropanoid-polysaccharide complex (PPC), has been shown to reduce total serum IgE levels as well as decreased production of IL-4, a cytokine associated with allergic disease. In this study, the investigators aim to determine the effects that PPC will have on total serum IgE levels in adult subjects with perennial rhinitis.

Conditions

Perennial Allergic Rhinitis

Keywords

perennial allergic rhinitis

Outcome Measures

Primary Outcomes (1)

• Primary Objective ( total serum IgE)

  To provide the proof-of-concept that daily administration of Immune Extra ™(each capsule with 16 mg total pine cone extract or 6 mg of PPC) reduces total serum IgE in subjects with rhinitis and sensitivity to perennial allergens, including dust mite (Dermatophagoides pteronyssinus and Dermatophagoides farinae), cockroach, cat, and dog.

  8 weeks

Study Arms (2)

capsule

ACTIVE COMPARATOR

patinets receiveing pine cone extract tablets

Dietary Supplement: pine cone extract

placebo capsule

PLACEBO COMPARATOR

patinets receiving placebo

Other: placebo

Interventions

pine cone extract DIETARY_SUPPLEMENT

pine cone extract capsule

capsule

placebo OTHER

placebo capsule

placebo capsule

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects with perennial allergic rhinitis with or without seasonal allergic rhinitis
• Male or female participants must be 18 years of age or older

You may not qualify if:

• Subjects receiving subcutaneous allergen immunotherapy or monoclonal anti-IgE (omalizumab)
• Subject with hypersensitivity to PPC
• Pregnant subjects (lactating post-partum women will be allowed to participate)
• Subjects who are unable to cooperate/comply with study procedures or communicate with investigator in order to successfully complete the study
• Subjects with severe skin disorders such as atopic dermatitis, dermatographism, psoriasis who could not have allergy skin testing and who have no prior skin testing completed within 3 years
• Subjects with an infirmity, disability, or geographical location which seems likely to prevent regular attendance for patient visits

Sponsors & Collaborators

• University of South Florida: lead

Study Sites (1)

Usf Asthma Allergy and Immunology Cru

Tampa, Florida, 33613, United States

Location

MeSH Terms

Conditions

Rhinitis, Allergic, Perennial

Interventions

PC6 extract

Condition Hierarchy (Ancestors)

Rhinitis, Allergic; Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Dennis Ledford, M.D.

  Division of Allergy and Immunology, USF

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2012
• First Posted: July 18, 2019
• Study Start: March 1, 2011
• Primary Completion: October 1, 2023
• Study Completion: October 1, 2023
• Last Updated: May 10, 2023

Record last verified: 2022-11

Locations

US (1)