Healthy volunteers healthy volunteers
Conditions
Interventions
Phase 1: Healthy volunteers: 6 people
1.1 Single Dose
Dosage 1: 6 volunteers ingested sangyu extract in tablet form at a dose of 800 mg. (4 tablets) before meals once.
Dose 2: 6 volunteers ingested sa
12 tablets per day) for 14 consecutive days
Dosage 1: 6 volunteers ingested sangyu extract in tablet form at a dose of 1,600 mg. (8 tablets) 3 times a day (4,800 mg per day
12 tablets per day) for 14 consecutive days
Phase 2: Farmers: 20 people
Group 1: 20 farmers ingested 1,600 milligrams of sangyu extract (8 tablets) 3 times a day (4,800 mg per day
24 tablets per day) before meals for 14 days during the pesticide use period.,Phase 1: Healthy volunteers: 2 people
1.1 Single Dose
Dosage 1: 2 volunteers ingested placebo extract in tablet form at a
12 tablets per day) for 14 consecutive days
Dosage 1: 2 volunteers ingested placebo extract in tablet form at a dose of 1,600 mg. (8 tablets) 3 times a day (4,800 mg per day
12 tablets per day) for 14 consecutive days
Phase 2: Farmers: 20 people
Group 2: 20 farmers ingested 1,600 milligrams of placebo extract (8 tablets) 3 times a day (4,800 mg per day
24 tablets per day) before meals for 14 days during the pesticide use period.
Experimental Other,Placebo Comparator Other
Sung-yu,Placebo
Sponsors
Highland Research and Development Institute (Public Organization)
Eligibility
Sex/Gender
All
Age
20 Years to 50 Years
Inclusion criteria
Inclusion criteria: 1. Healthy volunteers Male and female, age 20-50 years 2. Body mass index between 18-25 kg/square meter 3. No underlying disease 4.No drug addiction, no smoking. 5. No history of drug allergy 6. No history of food allergy 7. No abnormalities were found from physical examination. and no clinically significant abnormalities were found from laboratory tests such as Liver function test, Renal function test, Complete blood count, Fasting plasma glucose, Electrolytes and Electrocardiogram. 8. No history of using pesticides
Exclusion criteria
Exclusion criteria: 1.Have a history of ailments related to renal and hepatic impairment. 2. have a history of drug or drug use 3. Female volunteers who are pregnant or breastfeeding 4. Those who are currently participating in other research studies 5. Can't swallow pills 6. have a history of headache or monthly who need frequent pain relievers 7. Unable to abstain from alcoholic beverages throughout the research period. 8. Donate or lose more than 300 ml of blood at least 30 days before entering the program. 9. Those who cannot read or write Thai
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse reactions and laboratory results Pre-dose, Wk1 (Day2, 7), Wk2 (Day2, 7), Wk3 (Day4, 8, 12, 15), Wk7 (Day4, 8, 12, 15), Wk10 (Day1) total antioxidant capacity, LFT, Renal function test, CBC, FBS, PT, PTT | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse reactions and efficacy of Sungyu Pre-dose, Day2, 8, 15 Acetylcholinesterase activity (AchE, BchE), Superoxide dismutase (SOD), catalase (CAT), Glutathione sulfhydryl (GSH), LFT, Renal function test, CBC, FBS, PT, PTT | — |
Countries
Thailand
Contacts
Public ContactSaranyapin Potikanond
Department of Pharmacology Faculty of Medicine, Chiang Mai University
Outcome results
None listed