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Clinical Trial on the Effect of the Sublimated Mare Milk Supplement on Primary Biliary Cholangitis

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ClinicalTrials.gov Identifier: NCT03665519
Recruitment Status : Recruiting
First Posted : September 11, 2018
Last Update Posted : September 11, 2018
Sponsor:
Collaborators:
Eurasia Invest Ltd.
Ministry of Education and Science, Republic of Kazakhstan
Information provided by (Responsible Party):
National Scientific Medical Center, Kazakhstan

Tracking Information
First Submitted Date  ICMJE September 6, 2018
First Posted Date  ICMJE September 11, 2018
Last Update Posted Date September 11, 2018
Actual Study Start Date  ICMJE January 3, 2018
Estimated Primary Completion Date July 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 7, 2018)
  • Biochemical changes in liver function. [ Time Frame: Baseline, Month 4 ]
    Levels of alanine aminotransferase and aspartate aminotransferase will be measured from a biochemical blood test.
  • Change in intensity of asthenia in patients. [ Time Frame: Baseline, Month 4 ]
    Intensity of asthenia will be assessed with the State-Asthenic Scale by L. Malkova (adapted by Chertova) with scores less than 50 and more than 100 indicating no asthenia and pronounced asthenia respectively.
  • Evaluation of liver histology. [ Time Frame: Month 4 ]
    Liver histology, histochemistry, immunohistochemistry will be evaluated based on biopsy samples.
  • Change from baseline in hepatic encephalopathy indicator. [ Time Frame: Baseline, Month 4 ]
    Presence and stage of hepatic encephalopathy will be determined using the Reitan test (number connection test)
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 7, 2018)
  • Change in inflammatory biomaker (erythrocyte sedimentation rate). [ Time Frame: Baseline, Month 4 ]
    The erythrocyte sedimentation rate will be measured using the Panchenkov method
  • Determination of cholestasis presence/stage. [ Time Frame: Baseline, Month 4 ]
    Cholestasis will be assessed according to levels of gamma-glutamyltransferase, Alkaline phosphatase, direct bilirubin, total bilirubin from blood samples.
  • Evaluation of changes in synthetic function of liver (prothrombin time). [ Time Frame: Baseline, Month 4 ]
    Synthetic function of liver will be evaluated from the blood test result of prothrombin time.
  • Evaluation of changes in synthetic function of liver (fibrinogen). [ Time Frame: Baseline, Month 4 ]
    Synthetic function of liver will be evaluated from blood test results of fibrinogen, and platelet count.
  • Evaluation of changes in synthetic function of liver (albumin). [ Time Frame: Baseline, Month 4 ]
    Synthetic function of liver will be evaluated from blood test results of albumin.
  • Evaluation of changes in low-density lipoprotein. [ Time Frame: Baseline, Month 4 ]
    Synthetic function of liver will be evaluated from blood test results of low-density lipoprotein.
  • Evaluation of changes in total protein. [ Time Frame: Baseline, Month 4 ]
    Synthetic function of liver will be evaluated from blood test results of total protein.
  • Evaluation of changes in platelet count. [ Time Frame: Baseline, Month 4 ]
    Synthetic function of liver will be evaluated blood test results of platelet count.
  • Detection of anemia. [ Time Frame: Baseline, Month 4 ]
    Blood hemoglobin level will be used as a parameter for diagnosing anemia.
  • Hepatic hypertension [ Time Frame: Baseline, Month 4 ]
    Detection of hepatic hypertension will be carried out via platelet level assessment from the blood samples.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Trial on the Effect of the Sublimated Mare Milk Supplement on Primary Biliary Cholangitis
Official Title  ICMJE Clinical Trial on the Effect of Sublimated Mare Milk Supplement in Patients With Biliary Cholangitis
Brief Summary This study evaluates the effect of sublimated mare milk supplement on patients with biliary cholangitis
Detailed Description

Primary biliary cholangitis, formerly known as primary biliary cirrhosis, is a rare chronic disease that primarily affects women. Primary biliary cholangitis often progresses to the terminal stage of liver cirrhosis with its inherent complications. At this stage, the only way to save the patient's life is liver transplantation, and is accompanied by a number of painful symptoms (itching, mucous dryness, abdominal discomfort, fatigue), often restless legs syndrome, insomnia, depression and cognitive dysfunction.

The goal of the treatment is to prevent the terminal stage of cirrhosis of the liver and to alleviate the accompanying symptoms. Conventional drug therapy is aimed at slowing the progression of the disease and includes both approved for the use of these medications (ursodeoxycholic acid) and used outside the approved indications (derivatives of fibric acid, budesonide).

The role of this clinical trial is to increase the effectiveness of therapy for this disease. Against the background of the complexity of the treatment of primary biliary cholangitis, clinical medicine acquires a remedy in the form of a natural product - mare's milk, preventive, dietary, medicinal effects of which have been known for a long time. There are data from studies that have shown the efficacy and safety of using mare milk in patients with atopic dermatitis as well as with inflammatory bowel diseases. For the liver diseases, there are no reported studies.

In this trial, there will be two parallel groups: Interventional (supplement with standard treatment first for 3 months) and Standard treatment group. Differences in clinical, laboratory, liver encephalopathy and asthenia will be evaluated between groups.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Primary Biliary Cirrhosis
Intervention  ICMJE
  • Dietary Supplement: Sublimated mare milk
    The dietary supplement mare milk product, which is obtained from fresh mare milk (few hours) through sublimation process.
  • Drug: Ursodeoxycholic Acid
    Ursodeoxycholic acid treatment will be given for 3 months.
Study Arms  ICMJE
  • Experimental: Dietary supplement and ursodeoxycholic acid therapy.
    Participants will take a supplement (sublimated mare milk) of 1 sachet (20 mg) dissolved in 200 ml of warm water (36-37 °C) twice/day accompanied with standard therapy of ursodeoxycholic acid therapy (dosage of 15/kg/day) for 3 months.
    Interventions:
    • Dietary Supplement: Sublimated mare milk
    • Drug: Ursodeoxycholic Acid
  • Ursodeoxycholic acid therapy only.
    Patients would be given the standard treatment of ursodeoxycholic acid only for 3 months.
    Intervention: Drug: Ursodeoxycholic Acid
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 7, 2018)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date July 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients with morphologically verified diagnosis of primary biliary cholangitis
  • Aged 18 to 75 years
  • Willingness to consent to participate in the study
  • Consent to adhere to treatment

Exclusion Criteria:

  • Alcohol and/or drug dependence
  • Presence of liver cirrhosis class C based on Child Pugh classification
  • Allergic reaction to dairy products
  • Presence of mental diseases, severe concomitant pathology
  • Pregnancy and/or lactation
  • Lactose intolerance
  • Refusal to participate in the study
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Galiya Shaimardanova, PhD +77017299148 galiya_masugut@mail.ru
Contact: Gulmira Dossatayeva, MD, MBA +77015127500 g_dossatayeva@inbox.ru
Listed Location Countries  ICMJE Kazakhstan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03665519
Other Study ID Numbers  ICMJE NNMC.MM.BC.01
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party National Scientific Medical Center, Kazakhstan
Study Sponsor  ICMJE National Scientific Medical Center, Kazakhstan
Collaborators  ICMJE
  • Eurasia Invest Ltd.
  • Ministry of Education and Science, Republic of Kazakhstan
Investigators  ICMJE Not Provided
PRS Account National Scientific Medical Center, Kazakhstan
Verification Date September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP