Safety of Prasaprohyai 95%Ethanolic Extract Capsules in Healthy Volunteer

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: Prasaprohyai

• Registration Number: NCT03077282
• Lead Sponsor: 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)

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.

Study Timeline

• Study First Submitted: 2017-02-16
• Study First Submitted QC: 2017-03-06
• Study First Posted: 2017-03-10
• Status Verified: 2018-04
• Study Start: 2018-04-26
• Primary Completion: 2018-12-01
• Study Completion: 2018-12-14
• Last Update Submitted: 2019-06-24
• Last Update Posted: 2019-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group1	Prasaprohyai	Group1 will take Prasaprohyai 95% ethanolic extract capsules at a dose of 100 mg three times a day before meals (for 6 weeks)
group2	Prasaprohyai	Group2 will take Prasaprohyai 95% ethanolic extract capsules at a dose of 200 mg three times a day before meals (for 6 weeks)

Primary Outcome Measures

Name	Time	Method
Changes of Hematology test	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

Name	Time	Method
Diary note	Everyday until week8 after took Prasaprohyai	All volunteers will keep a diary of all symptoms and drugs used during the study

Trial Locations

Locations (1)

Thammasat university; 🇹🇭 Khlong Luang, Pathumthani, Thailand