- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02569359
Efficacy and Safety of Shea Nut Oil in Hemophilic Arthropathy
April 1, 2021 updated by: Tsung-Ying Li, Tri-Service General Hospital
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Detailed Description
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% triterpenes derived from the seed of the shea tree, Vitellaria paradoxa.
The most abundant triterpenes in shea nut oil areα-amyrin(54.6%),
β-amyrin(12.3%),
Lupeol(17%) plus their dihydro-derivatives.
Cheras et al. reported that shea nut oil extract treatment over the 15 weeks of their random double-blind study in upper quartile of 89 osteoarthritis patients was effective in decreasing inflammation marker TNF-α (23.9% vs 6%, treatment vs placebo) and cartilage degradation marker C-terminal crosslinked telopeptide type II collagen (CTX-II) (28.7% vs an increase of 17.6%, treatment vs placebo).
Chen and his colleagues carried out a 16-week study in 33 patients with osteoarthritis of knee joint and found shea nut oil was effective in increasing activity and thickness of vastus medialis, and decreasing pain and stiffness of knee joint.
Late stage of hemophilic arthropathy is characterized by advanced cartilage degeneration and joint destruction.
These effects on cartilage and subchondral bone are degenerative and inflammatory in nature, similar to the changes in osteoarthritis.
Management of chronic hemophilic arthropathy is difficult.
NSAIDs have been used with caution in patients with bleeding disorders because of their inhibition of platelet function and gastrointestinal side effects.
In clinical practice, the choice of 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.
Study Type
Interventional
Enrollment (Actual)
6
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Taipei, Taiwan, 114
- Hemophilia care and research center
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- age 20 years and above
- hemophilia A or B patients who reported painful (VAS ≥ 3) hemophilic arthropathy in ankles, elbows or knees for at least 6 months.
Exclusion Criteria:
- presence of joint infections
- any surgery on the joint in preceding 6 months
- intra-articular HA injection within the past 6 months
- history of rheumatoid arthritis,
- gouty arthropathy
- presence of neoplasm,
- allergy to shea nut oil production
- use of corticosteroids within 3 weeks prior to baseline and throughout the study
- use of anti-inflammatory agents 3 weeks prior to baseline and for the duration of the study,
- history of trauma associated with the signal joint,
- liver function tests greater than twice the upper limit of normal at baseline
- history of alcohol or substance abuse.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Shea nut oil
100% shea nut oil extract with 75% triterpene esters.
Daily dosage is three 750 mg soft gel capsules (2250 mg/per day) taken in the morning for 3 months
|
|
Placebo Comparator: Placebo
placebo which comprised 100% canola oil or starch mixed soybean oil
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
baseline, 1 month, 3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
baseline, 1 month, 3 months
|
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.
|
baseline, 1 month, 3 months
|
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
|
baseline, 1 month, 3 months
|
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
|
baseline, 1 month, 3 months
|
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.
|
baseline, 1 month, 3 months
|
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.
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baseline, 1 month, 3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Tsung-Ying Li, Hemophilia care and research center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2016
Primary Completion (Actual)
September 1, 2018
Study Completion (Actual)
September 1, 2018
Study Registration Dates
First Submitted
October 1, 2015
First Submitted That Met QC Criteria
October 4, 2015
First Posted (Estimate)
October 6, 2015
Study Record Updates
Last Update Posted (Actual)
April 6, 2021
Last Update Submitted That Met QC Criteria
April 1, 2021
Last Verified
April 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1-104-05-041
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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