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Treatment of Chronic HCV Infected Egyptian Patients With Electromagnetic Waves and Herbal Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02215525
Recruitment Status : Unknown
Verified July 2014 by Egyptian Military Medical Services.
Recruitment status was:  Recruiting
First Posted : August 13, 2014
Last Update Posted : August 13, 2014
Sponsor:
Collaborator:
EMS
Information provided by (Responsible Party):
Egyptian Military Medical Services

Brief Summary:
A Randomized, Open-Label, Study to evaluate and compare the efficacy and safety, of extracorporeal irradiation of circulating blood by UVA with antioxidant as a supplement (Selenium containing food supplement herbal tablets) in the treatment of non-cirrhotic subjects with chronic hepatitis C.

Condition or disease Intervention/treatment Phase
Hepatitis C Device: UVA Dietary Supplement: Herbal Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Treatment of Chronic HCV Infected Egyptian Patients With Electromagnetic Waves and Herbal Therapy
Study Start Date : April 2014
Estimated Primary Completion Date : October 2014
Estimated Study Completion Date : May 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: UVA and Herbal
Twenty four daily one hour sessions using Extra-corporeal electro-magnetic irradiation device combined with Herbal Food Supplement Selenium containing tables as an Anti Oxidant (Tablet A) starting 10 days before the radiation sessions and to continue for 24 weeks
Device: UVA
device uses UVA
Other Name: UVA device

Experimental: Herbal
Chronic HCV patients, non complicated will be treated by Herbal tablets only . 500 mg twice tablets every 6 hours daily for 6 months.
Dietary Supplement: Herbal
Herbal tablets, 1000 mg every 6 hours daily for 6 months
Other Name: Herbal tablets




Primary Outcome Measures :
  1. sustained virological response (SVR) at 12 weeks [ Time Frame: 12 weeks after the end of treatment ]
    SVR is defined as an absence of detectable HCV RNA in the serum with use of an assay with a sensitivity of at least 50 IU/mL.


Secondary Outcome Measures :
  1. Sustained Virological Response (SVR) at 24 weeks [ Time Frame: 24 weeks after completion of the course of treatment. ]
    Absence of detectable HCV RNA in the serum with use of an assay with a sensitivity of at least 50 IU/mL.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female between the age of 21 and 60 years.
  2. Female subjects of childbearing potential must be willing to use effective form of birth control.
  3. Sexually active fertile females in childbearing period must have negative results for pregnancy tests.
  4. Sexually active fertile males must agree either him or his wife to practicing effective form of birth control.
  5. Subject should be treatment: Non cirrhotic HCV chronic Hepatitis.
  6. Subjects must be able to understand and to adhere to the study visits schedule.
  7. Body mass index (BMI) is >18 to <35kg/m2.
  8. Must voluntarily sign and date an informed consent, approved by an Institutional Review Board/Ethics Committee (IRB/EC), prior to the initiation of any study-specific procedures.
  9. Chronic HCV for at least 6 months prior to study enrolment. Chronic HCV infection is defined as one of the following:

    • Positive for anti-HCV antibody or HCV RNA at least 6 months before Screening, and positive for HCV RNA and anti-HCV antibody at the time of Screening; OR
    • Positive for anti-HCV antibody and HCV RNA at the time of Screening with a liver biopsy consistent with chronic HCV infection (or a liver biopsy performed prior to enrolment with evidence of chronic hepatitis C disease).
  10. Absence of cirrhosis judged by documented results of :-

    • Liver Ultrasound. OR
    • Fibro Test score of ≤ 0.75 and Aspartate Amino transferase to Platelet Ratio Index (APRI) ((AST/AST ULN)X100)/Plt in thousands) ≤ 2 at Screening, OR
    • FibroScan® result of <14.5kPa, OR
    • The absence of cirrhosis based on a liver biopsy within the last 36months.
  11. If the rewire multiple assessments on the same date for a subject, fibrosis score was calculated in the order of liver biopsy, FibroScan, and Fibro Test. If the rewire assessments on different dates for a subject by different methods, fibrosis score was calculated n the order of liver biopsy, FibroScan, and Fibro Test. If the rewire assessments on different dates for a subject by the same method, fibrosis score was calculated by maximum value.
  12. Subject has a plasma HCV RNA level >10,000 International Units (IU)/mLat screening.

Exclusion Criteria:

  1. History of severe, life-threatening or other significant sensitivity to any drug.
  2. Females who are pregnant or breast feeding.
  3. Recent (within 6-months prior to study drug administration) history of drug or alcohol abuse that could preclude adherence to the protocol.
  4. Positive test result for hepatitis B surface antigen (HbsAg) or anti-HIV antibodies (anti-HIV Ab).
  5. Clinically significant abnormalities, other than HCV infection, based upon the results of a medical history, physical examination, vital signs, laboratory profile, a 12-lead electrocardiogram (ECG) and echocardiography that make the subject an unsuitable candidate for this study in the opinion of the Investigator.
  6. History of uncontrolled seizures, cancer, or uncontrolled diabetes, as defined by a HbA1C level >8.0%.
  7. Any current or past clinical evidence of cirrhosis , a history or presence of ascites, oesophageal varices, or hepatic encephalopathy.
  8. Known cause of liver disease other than chronic HCV infection.
  9. Screening laboratory analyses show any of the following abnormal laboratory results:

    • Alanine amino transferase (ALT) >5X upper limit of normal (ULN),
    • Aspartate amino transferase (AST) >5X upper limit of normal (ULN),
    • Calculated creatinine clearance (using Cockcroft-Gault method) <50mL/min,
    • Albumin<lower limit of normal (LLN),
    • Prothrombin time INR > 1.5,
    • Haemoglobin < 11 %,
    • Platelets<120,000cellsper mm3
    • Absolute neutrophil count <1500cells/µL,
    • Total bilirubin> 1.5 mg/dL,
  10. Clinically significant abnormal echocardiography or ECG.
  11. Any contraindications to central venous catheter insertion.
  12. Previous history of photosensitivity, skin cancer or presence of a positive family history of Skin Cancer.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02215525


Contacts
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Contact: Tayseer A Abdulaal, M.D. +201223407675 tayseer70@gmail.com

Locations
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Egypt
EMMS Recruiting
Cairo, Heliopolis, Egypt, 11613
Contact: Tayseer A Abdulaal, M.D.    +201223407675    tayseer70@gmail.com   
Principal Investigator: Tayseer A Abdulaal, M.D.         
Sponsors and Collaborators
Egyptian Military Medical Services
EMS
Investigators
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Principal Investigator: Tayseer A Abdulaal, M.D. EMMS

Additional Information:
Publications:
Efficacy of ultraviolet blood irradiation therapy in the control of staphylococcemias. The American Journal of Surgery, Volume 64, Issue 3, June 1944, Pages 313-322
George Miley Ultraviolet blood irradiation therapy (Knott technic) in acute pyogenic infections. The American Journal of Surgery, Volume 57, Issue 3, September 1942, Pages 493-50

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Responsible Party: Egyptian Military Medical Services
ClinicalTrials.gov Identifier: NCT02215525    
Other Study ID Numbers: EMMS 2014 1
First Posted: August 13, 2014    Key Record Dates
Last Update Posted: August 13, 2014
Last Verified: July 2014
Keywords provided by Egyptian Military Medical Services:
HCV
UVA
Herbal therapy
Additional relevant MeSH terms:
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Hepatitis C
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections