NCT03077282

Safety of Prasaprohyai 95%Ethanolic Extract Capsules in Healthy Volunteer

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Thammasat University · Academic / Other
• Sex: All
• Age: 20 Years – 60 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Prasaprohyai	Prasaprohyai 95% ethanolic extract capsules will take three times a day before meals

Timeline

• Start date: 2018-04-26
• Primary completion: 2018-12-01
• Completion: 2018-12-14
• First posted: 2017-03-10
• Last updated: 2019-06-26

Locations

1 site across 1 country: Thailand