Safety of Prasaprohyai 95%Ethanolic Extract Capsules in Healthy Volunteer

NCT03077282 | Completed Phase 1 DMC

• 1 other identifier: MTU-EC-TM-4-137/59
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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)

Conditions

Healthy Volunteers

Keywords

Prasaprohyai extract, Healthy volunteers

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Diary note

  Everyday until week8 after took Prasaprohyai

Study Arms (2)

group1

EXPERIMENTAL

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

group2

EXPERIMENTAL

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

Interventions

Prasaprohyai DRUG

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

group1; group2

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \) Age in range 20-60 years old.
• \) 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.
• \) Do not taking a medicine constantly.
• \) Female not pregnant or lactating (non menopause woman will have a pregnancy test. Time since first day of last menstruation 28-35 days).
• \) Participant and agreement to follow the instructions for 8 weeks.
• \) Not a participant in another study.

You may not qualify if:

• \) Allergic reactions to Prasaprohyai medications.

Sponsors & Collaborators

• Thammasat University: lead
• Thai Traditional Medical Knowledge Fund: collaborator

Study Sites (1)

Thammasat university

Khlong Luang, Changwat Pathum Thani, 12120, Thailand

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: February 16, 2017
• First Posted: March 10, 2017
• Study Start: April 26, 2018
• Primary Completion: December 1, 2018
• Study Completion: December 14, 2018
• Last Updated: June 26, 2019

Record last verified: 2018-04

Locations

TH (1)