Camel Whey Protein Gel for the Treatment of Aphthous Ulcer

NCT04886011 | Completed DMC

• 1 other identifier: KFSAPH2021
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief Summary

Higher prevalence of recurrent aphthous ulcer in young adults and the severity decreased with increasing age. The etiology of aphthous ulcer remains unclear. Other possible factors include trauma, drug use, deficiency in vitamin B12, folic acid, iron, stress, hormonal changes and metabolic diseases. Many topical agents such as local and systemic an- tibiotics, local antiseptics, topical NSAIDs, and topical corticosteroids are generally prescribed for symptomatic relief. Several approved drug for- mulations such as pills, mouthwash, sprays and paste such as vitamin B12, chlorhexidine mouthwash, steroid lozenges and local anesthetics are primarily suggested for the treatment of aphthous ulcer. Camel whey protein gel was fabricated to get benefits of its antiinflammatory, immunomodulator, Antibacterial and antioxidant effects.

Conditions

Aphthous Stomatitis, Recurrent; Antioxidative Stress

Outcome Measures

Primary Outcomes (2)

• pain level

  visual analog scale to measure pain level from 0 to 10. 0 means no pain at all and 10 means the most sever pain

  1 week

• ulcer duration

  time extended from ulcer presence till disseverance

  10 days

Secondary Outcomes (1)

• immunological analysis

  10 days

Study Arms (2)

placebo gel

PLACEBO COMPARATOR

Methylcellulose gel was applied to the ulcer till complete healing

Combination Product: placebo gel

camel whey protein gel

EXPERIMENTAL

camel whey protein dissolved in methycellulose gel was applied to the ulcer till complete healing

Combination Product: camel whey protein gel

Interventions

placebo gel COMBINATION_PRODUCT

just methyl cellulose gel was applied to the ulcer

placebo gel

camel whey protein gel COMBINATION_PRODUCT

camel whey protein gel was prepared and dissolved in methyl cellulose gel base and applied to the ulcer

camel whey protein gel

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• clinical examination and confirmed history of recurrent oral ulcer,
• recurrence of the oral ulceration
• patients in good condition with no serious systemic disease.

You may not qualify if:

• if they were administered antibiotics or glucocorticoids
• accepted periodontal or dental treat-ments that interfered with the results of our experimental drugs

Sponsors & Collaborators

• Kafrelsheikh University: lead

Study Sites (2)

oral medicine and periodontology outpatient clinic, faculty of dentistry, kafrelsheikh University

Kafr ash Shaykh, Kafrelsheikh, 214312, Egypt

Location

Walid Elamrousy

Kafr ash Shaykh, 21614, Egypt

Location

MeSH Terms

Conditions

Sutton disease 2

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investivagor and lecturer of oral medicine and periodontology, faculty of dentistry, kafrelsheikh university

Model Details: Methylcellulose gel

Study Record Dates

• First Submitted: May 8, 2021
• First Posted: May 13, 2021
• Study Start: May 15, 2021
• Primary Completion: October 15, 2021
• Study Completion: November 30, 2021
• Last Updated: September 13, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (2)