Study on the Safety of Kerra Formula Capsule by Oral Administration on Healthy Volunteers

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

TCTR

Registry ID

TCTR20230320009

Enrollment

Registered

2023-03-20

Start date

2022-11-03

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

healthy volunteers phase I clinical trial, safety, Kerra Formula Capsules

Interventions

The volunteers orally received two capsules (500 mg/cap) four times per day, three times before meals and once before bedtime, for 14 days.

Experimental Drug

Kerra Formula Capsule: traditional medicine (number G40/57)

Eligibility

Sex/Gender

All

Age

20 Years to 35 Years

Inclusion criteria

Inclusion criteria: 1. Healthy volunteers, 2. Participants with no history of congenital diseases, as determined through a medical history and physical examination, 3. Participants who do not smoke or drink alcohol regularly, and are not addicted to drugs, 4. Participants who do not regularly take any medications, supplements, or health products , 5. Participants with no history of infection with Coronavirus-2019, 6. Participants who provide consent to participate in the project

Exclusion criteria

Exclusion criteria: 1. Participants who are unable to provide blood samples, 2. Individuals with a history of drug, herb, or food allergies, 3. Female volunteers who are pregnant or have the potential to become pregnant, 4. Participants who are infected with COVID-19, 5. Individuals with abnormal laboratory results indicating impaired liver or kidney function, abnormal coagulation values, or abnormal blood sugar levels

Design outcomes

Primary

Measure	Time frame
Normal blood analysis 1, 7, 14 days 14 days after the washout period CBC,Coagulogram 1, 7, 14 days 14 days after the washout period PT and APTT,Renal function 1, 7, 14 days 14 days after the washout period AST, ALT, ALP,Kidney function 1, 7, 14 days, 14 days after the washout period BUN, Creatine, Urinalysis,Inflammation 1, 7, 14 days, 14 days after the washout period ESR, CRP,Glucose level 1, 7, 14 days, 14 days after the washout period FBS,Lipid profiles 1, 7, 14 days, 14 days after the washout period Cholesteral, Triglyceride, HDL, LDL	—

Measure

Time frame

Normal blood analysis 1, 7, 14 days 14 days after the washout period CBC,Coagulogram 1, 7, 14 days 14 days after the washout period PT and APTT,Renal function 1, 7, 14 days 14 days after the washout period AST, ALT, ALP,Kidney function 1, 7, 14 days, 14 days after the washout period BUN, Creatine, Urinalysis,Inflammation 1, 7, 14 days, 14 days after the washout period ESR, CRP,Glucose level 1, 7, 14 days, 14 days after the washout period FBS,Lipid profiles 1, 7, 14 days, 14 days after the washout period Cholesteral, Triglyceride, HDL, LDL

—

Secondary

Measure	Time frame
Adverse effect 1, 7, 14 days, 14 days after the washout period Physical examination	—

Countries

Thailand

Contacts

Public ContactSuriyan Sukati

Walailak University

suriyan.su@wu.ac.th075672629

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026