Clinical Trial: Efficacy and Safety of Shea Nut Oil in Hemophilic Arthropathy

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title:

Brief Summary: Recurrent hemarthrosis results in synovitis and destructive arthropathy in hemophilic patients. Prophylactic replacement, physical therapy, cyclooxygenase-2 (COX-2) inhibitors, corticosteroids, and radionucleotide synovectomy are some of the typical modalities used in the managements hemophilic synovitis and arthropathy. In clinical practice, the choice of non-steroidal anti-inflammatory drugs (NSAIDs) also needs to take into consideration the risk for cardiovascular events and should be used at the lowest effective dose and for the shortest duration.This study will investigate the safety and efficacy of Shea nut oil for the treatment of hemophilic arthropathy.

Detailed Summary: Hemophilia is an X-linked recessive bleeding disorder caused by a deficiency of coagulation factor VIII (hemophilia A) or IX (hemophilia B). Severe hemophilia patients may have frequent spontaneous bleeding episodes such as joint and muscle bleeding. Repeated joint bleeding leads to chronic synovitis, cartilage damage and bony destruction, which is associated with range of motion (ROM) limitation, pain, muscle atrophy, functional impairment and poor quality of life. Around 80% of all spontaneous joint bleeds occur in the ankles, knees and elbows. Hemophilic arthropathy is a multifactorial event and there is evidence to suggest that iron may play a major role with release of cytokines such as Interleukin-1, Interleukin-6, and tumor necrosis factor-α (TNF-α) eading to chronic proliferative synovitis, hypervascularity, and progressive arthropathy . Prophylactic replacement , physical therapy, COX-2 inhibitors , corticosteroids, and radionucleotide synovectomy are some of the typical modalities used in the managements hemophilic synovitis and arthropathy. The onset of joint bleedings in severe hemophilia occurs approximately 23 months of age and arthropathy could be marked in adolescents or young adults. Some hemophilia patients may either not be good candidates for surgery or may prefer not to have surgery. The traditional Africans have used African Shea tree and shea nuts oil extracts to treat arthritis. Shea nut oil contains are a mixture of fatty acid and cinnamic acid esters of such triterpene alcohols as α-amyrine, β-amyrine, butyrospermol, lupeol and to aminor extent, sterols, aliphatic alcohols, and karitene. Triterpene alcohols such as lupeol and α/β-amyrine have been shown to possess anti-inflammatory effects, especially in their esterified forms. In 1998, US Food and Drug Administration approved shea nut oil as a safe food additive. The shea nut oil used in this trial is a patented concentrate containing approximately 50% triterp
Sponsor: Tri-Service General Hospital

Current Primary Outcome: Pain (visual analogue scale) and Change from Baseline Pain at 1 &3 months [ Time Frame: baseline, 1 month, 3 months ]

The pain intensity will be evaluated subjectively on a visual analogue scale (0-100mm).


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • CTX-II (ng/mmol creatinine) and Change from Baseline at 1 & 3 months [ Time Frame: baseline, 1 month, 3 months ]
    C-telopeptide fragments of type II collagen (CTX-II) in urine is a measure of type II collagen degradation and a biological marker of arthropathy.
  • Tumor Necrosis Factor alpha (pg/mL) and Change from Baseline at 1 & 3 months [ Time Frame: baseline, 1 month, 3 months ]
    TNF-alpha are one of inflammatory mediators that increase following hemarthrosis in hemophilic mice. Plasma samples will tested by ELISA.
  • Ultrasonographic synovial thickness (mm) and Change from Baseline at 1 &3 months [ Time Frame: baseline, 1 month, 3 months ]
    Synovial thickness (mm) by ultrasonography were evaluated from the lateral, middle, and medial aspects of the anterior suprapatellar recess
  • Synovial hyperemia (score) and Change from Baseline at 1& 3 months [ Time Frame: baseline, 1 month, 3 months ]
    Power Doppler assessment of selected synovial sites is carried out with settings standardized to a pulse repetition frequency of 700 Hz. The intensity of the blood flow in the synovium is scored into 0 to 3 (0=No flag; 1 = 1 flag; 2 = 2-3 flags; 3=>3 flags) adapted from Klukowska and Melchiorre et al
  • Short Form -36 score and Change from Baseline at 1 & 3 months [ Time Frame: baseline, 1 month, 3 months ]
    The SF-36 is filled out taking into account the person's condition in the last one month and scores range from 0 to 100, with higher scores indicating better health-related quality of life.
  • Hemophilia Joint Health Score (HJHS) and Change from Baseline at 1 & 3 months [ Time Frame: baseline, 1 month, 3 months ]
    The HJHS is a structured physical examination score evaluating the joint health in hemophilia patient. The score for each joint is the sum of the individual items including swelling, swelling duration, muscle atrophy, axial alignment, crepitus of motion, flexion loss & extension loss, joint pain and strength. A score of 20 suggests the worst possible damage/impairment in the evaluating joint.


Original Secondary Outcome: Same as current

Information By: Tri-Service General Hospital

Dates:
Date Received: October 1, 2015
Date Started: April 2016
Date Completion:
Last Updated: November 9, 2016
Last Verified: November 2016