Clinical trial NCT03077282: Safety of Prasaprohyai 95%Ethanolic Extract Capsules in Healthy Volunteer
Official title: Quality Control and Safety of Prasaprohyai 95%Ethanolic Extract Capsules in Healthy Volunteer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: Prasaprohyai extract, Healthy volunteers
Lead sponsor: Thammasat University
Sponsor class: OTHER
Collaborators: name: Thai Traditional Medical Knowledge Fund
First posted: 2017-03-10
Enrollment: 24
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Changes of Hematology test
timeFrame: week0, week3, week6 and week8
Secondary outcomes:
measure: Diary note
timeFrame: Everyday until week8 after took Prasaprohyai
Other outcomes:
Locations:
city: Khlong Luang
country: Thailand
facility: Thammasat university
state: Pathumthani
Study officials:
References: