Safety of Prasaprohyai 95%Ethanolic Extract Capsules in Healthy Volunteer

Healthy Volunteers Clinical Trial

Official title:

Quality Control and Safety of Prasaprohyai 95%Ethanolic Extract Capsules in Healthy Volunteer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03077282
• Other study ID #: MTU-EC-TM-4-137/59
• Status: Completed
• Phase: Phase 1
• Start date: April 26, 2018
• Est. completion date: December 14, 2018

Study information

• Verified date: April 2018
• Source: Thammasat University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: December 14, 2018
• Est. primary completion date: December 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Prasaprohyai
Prasaprohyai 95% ethanolic extract capsules will take three times a day before meals

Locations

Country	Name	City	State
Thailand	Thammasat university	Khlong Luang	Pathumthani

Sponsors (2)

Lead Sponsor	Collaborator
Thammasat University	Thai Traditional Medical Knowledge Fund

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes of Hematology test	All volunteers will receive a hematology test to check renal function, liver function, lipid profile, glucose, complete blood count	week0, week3, week6 and week8
Secondary	Diary note	All volunteers will keep a diary of all symptoms and drugs used during the study	Everyday until week8 after took Prasaprohyai