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Safety of Prasaprohyai 95%Ethanolic Extract Capsules in Healthy Volunteer

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: NCT03077282
Recruitment Status : Completed
First Posted : March 10, 2017
Last Update Posted : June 26, 2019
Sponsor:
Collaborator:
Thai Traditional Medical Knowledge Fund
Information provided by (Responsible Party):
Miss Nichamon Mukkasombut, Thammasat University

Brief Summary:
To investigate the safety of Prasaprohyai 95% ethanolic extract at doses of 100 mg and 200 mg for for 6 weeks. (Clinical Trial phase I)

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: Prasaprohyai Phase 1

Detailed Description:

Sample size Group 1 (100mg/meal) = 6 female, 6 male Group 2 (200mg/meal) = 6 female, 6 male

Volunteers will be divided into 2 groups. One will take Prasaprohyai 95% ethanolic extract capsules at a dose of 100 mg three times a day before meals and the other take Prasaprohyai 95% ethanolic extract capsule at a dose of 200 mg 3 times a day before meals for six weeks. After that, they will cease using the drug for 2 weeks (wash out period). All volunteers will be followed up in the third week, sixth week and eighth week to evaluate the safety of the medicines. The researcher will record data such as age, career, BMI, vital signs, signs and symptoms. Safety will be monitored by hematology tests such as liver function test, renal function test, lipid profile and blood sugar.

The first step in this research will be to study group 1 (100 mg). If it proves safe, the group 2 (200 mg) will be studied.

The data gathered will be evaluated using statistical software. The results are in the form of mean ± standard deviation. The study will be planned as repeated measured ANOVA or Friedman's test in order to evaluate differences between groups, accompanied by using paired t-test or Wilcoxon's test in order to evaluate differences within groups. A significance level of p < 0.05 will be considered statistically significant.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Volunteers will be divided into 2 groups. One will take Prasaprohyai 95% ethanolic extract capsules at a dose of 100 mg three times a day before meals and the other take Prasaprohyai 95% ethanolic extract capsule at a dose of 200 mg 3 times a day before meals for six weeks. After that, they will cease using the drug for 2 weeks (wash out period). All volunteers will be followed up in the third week, sixth week and eighth week to evaluate the safety of the medicines. The researcher will record data such as age, career, BMI, vital signs, signs and symptoms. Safety will be monitored by hematology tests such as liver function test, renal function test, lipid profile and blood sugar.

The first step in this research will be to study group 1 (100 mg). If it proves safe, the group 2 (200 mg) will be studied.

Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Quality Control and Safety of Prasaprohyai 95%Ethanolic Extract Capsules in Healthy Volunteer
Actual Study Start Date : April 26, 2018
Actual Primary Completion Date : December 1, 2018
Actual Study Completion Date : December 14, 2018

Arm Intervention/treatment
Experimental: group1
Group1 will take Prasaprohyai 95% ethanolic extract capsules at a dose of 100 mg three times a day before meals (for 6 weeks)
Drug: Prasaprohyai
Prasaprohyai 95% ethanolic extract capsules will take three times a day before meals

Experimental: group2
Group2 will take Prasaprohyai 95% ethanolic extract capsules at a dose of 200 mg three times a day before meals (for 6 weeks)
Drug: Prasaprohyai
Prasaprohyai 95% ethanolic extract capsules will take three times a day before meals




Primary Outcome Measures :
  1. Changes of Hematology test [ Time Frame: week0, week3, week6 and week8 ]
    All volunteers will receive a hematology test to check renal function, liver function, lipid profile, glucose, complete blood count


Secondary Outcome Measures :
  1. Diary note [ Time Frame: Everyday until week8 after took Prasaprohyai ]
    All volunteers will keep a diary of all symptoms and drugs used during the study



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:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 1) Age in range 20-60 years old.
  • 2) Healthy, or don't have serious medical conditions such as congestive heart disease, liver and renal dysfunction, uncontrolled hypertension, severe asthma, tuberculosis, HIV in the previous month before being recruited in the study, using history taking and complete physical examination and laboratory result.
  • 3) Do not taking a medicine constantly.
  • 4) Female not pregnant or lactating (non menopause woman will have a pregnancy test. Time since first day of last menstruation 28-35 days).
  • 5) Participant and agreement to follow the instructions for 8 weeks.
  • 6) Not a participant in another study.

Exclusion Criteria:

  • 1) Allergic reactions to Prasaprohyai medications.

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): NCT03077282


Locations
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Thailand
Thammasat university
Khlong Luang, Pathumthani, Thailand, 12120
Sponsors and Collaborators
Thammasat University
Thai Traditional Medical Knowledge Fund

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Responsible Party: Miss Nichamon Mukkasombut, Principal Investigator, Thammasat University
ClinicalTrials.gov Identifier: NCT03077282    
Other Study ID Numbers: MTU-EC-TM-4-137/59
First Posted: March 10, 2017    Key Record Dates
Last Update Posted: June 26, 2019
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: safety of Prasaprohyai 95%ethanolic extract capsules in healthy volunteer (liver function test, renal function test, CBC, BP)

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Miss Nichamon Mukkasombut, Thammasat University:
Prasaprohyai extract, Healthy volunteers