Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Thai Traditional Medical Knowledge Fund | OTHER_GOV |
Not provided
Not provided
Not provided
Not provided
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)
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
|
| 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prasaprohyai | Drug | Prasaprohyai 95% ethanolic extract capsules will take three times a day before meals |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Diary note | All volunteers will keep a diary of all symptoms and drugs used during the study | Everyday until week8 after took Prasaprohyai |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Thammasat university | Khlong Luang | Changwat Pathum Thani | 12120 | Thailand |
safety of Prasaprohyai 95%ethanolic extract capsules in healthy volunteer (liver function test, renal function test, CBC, BP)
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided