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Trial record 32 of 3342 for:    China Medicine University Hospital

The Effects of Trichosanthes Root on Blood Sugar in Patients With Diabetes Mellitus

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ClinicalTrials.gov Identifier: NCT02855645
Recruitment Status : Unknown
Verified November 2016 by China Medical University Hospital.
Recruitment status was:  Recruiting
First Posted : August 4, 2016
Last Update Posted : November 16, 2016
Sponsor:
Information provided by (Responsible Party):
China Medical University Hospital

Brief Summary:
Diabetes mellitus (DM) locates fifth of ten leading death etiology, the population of diabetic patients has a tendency of increase. Trichosanthes root is called as Tian Hua Fen, According to traditional Chinese writing record that Trichosanthes root has the action of downbear fire, moisten dryness, and slippery phlegm, and release thirst. The Trichosanthes root may lower blood sugar levels in the modern study. The investigators designed a double blind, randomized controlled study, a total of 60 diabetic patients with high blood sugar were divided into treatment and control groups, and each group was 30 patients. In the treatment group, oral administration of Trichosanthes root 1.5 g, bid/day for 84 days continuously; in the control group, oral administration of Trichosanthes root placebo 1.5 g, bid/day for 84 days continuously. The main outcome measure was the changes of plasma blood sugar and Glycated hemoglobin A1c (HbA1c) levels changed before and after Trichosanthes root treatment. The investigators predict the results of the present study indicated that Trichosanthes root can improve plasma blood sugar and glycated hemoglobin A1c levels.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Drug: Trichosanthes root Drug: Placebo Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : July 2016
Estimated Primary Completion Date : April 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: A1C Blood Sugar

Arm Intervention/treatment
Experimental: Trichosanthes root
Trichosanthes root at a rate of 1.5 g two times per day for 84 days.
Drug: Trichosanthes root
Trichosanthes root at a rate of 1.5 g two times per day for 84 days.

Placebo Comparator: Placebo
Trichosanthes root at a rate of 0.15g (10%) two times per day for 84 days.
Drug: Placebo
Trichosanthes root at a rate of 0.15g (10%) two times per day for 84 days.




Primary Outcome Measures :
  1. Glycated hemoglobin A1c [ Time Frame: Three months ]
    Improvement of glycated hemoglobin A1c levels

  2. Plasma Blood Sugar [ Time Frame: Three months ]
    Improvement of Plasma Blood Sugar levels



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Early diagnosis Type Ⅱ Diabetic patients who Glycated hemoglobin A1c level between 7.0% and 9.0% (including) , and after three months of diet and exercise control.
  2. The subject who was taking hypoglycemic drugs Metformin, the maximum total amount of ≦ 1500 mg / day.
  3. Age ranged between 20 and 80 years (including).

Exclusion Criteria:

  1. Pregnancy or breast-finding.
  2. Allergy to test medicine.
  3. Type I Diabetic patients.
  4. Bleeding tendency.
  5. The participants who suffered from serious disorders, such as congestive heart failure, myocardial infarction, chronic obstructive pulmonary disease, renal failure, cancer or stroke etc.
  6. Irritable or anxious patients who cannot be assessed.
  7. Refuse to sign the agreement.
  8. The values of SGOT and SGPT levels were more than normal limit triple, or the value of creatinine level was more than normal limit.
  9. Plasm glucose(Glucose AC) level in fasting state ≧ 300 mg / dL.

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): NCT02855645


Contacts
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Contact: Ching-Liang Hsieh, M.D. , Ph.D +886-4-22053366 ext 3500 clhsieh@mail.cmuh.org.tw

Locations
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Taiwan
China Medical University Hospital Recruiting
Taichung, Taiwan, 404
Contact: Ching-Liang Hsieh, professor    +886-4-22053366 ext 3500    clhsieh@mail.cmuh.org.tw   
Sponsors and Collaborators
China Medical University Hospital
Investigators
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Study Chair: Ching-Liang Hsieh China Medical University Hospital

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Responsible Party: China Medical University Hospital
ClinicalTrials.gov Identifier: NCT02855645     History of Changes
Other Study ID Numbers: CMUH105-REC2-052
First Posted: August 4, 2016    Key Record Dates
Last Update Posted: November 16, 2016
Last Verified: November 2016

Keywords provided by China Medical University Hospital:
Trichosanthes root
Traditional Chinese Medicine
Clinical trial

Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases