The Clinical Pharmacokinetics of Sahastara Remedy Alcoholic Extract Capsule in Healthy Volunteers

Phase 1

Recruiting

• Conditions: Osteoarthritis of the knee; Sahastara remedy; Pharmacokinetics; Herbal medicine; Piperine

• Registration Number: TCTR20160729002
• Lead Sponsor: ational Research Council of Thailand (NRTC)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-07-29
• Study Completion: 2016-10-20
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

1. Both sex age between 20-45 years
2. No pregnancy
3. No Serious Medical Condition evaluated by Physical Examination and Laboratory results in 1 month before study
4. No Supplementary and/or Vitamin during the study
5. Able to follow suggestion during the study

Exclusion Criteria

1. Have uncontrolled Hypertension (BP>140/90)
2. BMI > 30
3. Have Serious Medical condition such as Serious Peptic Ulcer, Congestive hearth disease, liver and renal dysfunction
4. On during use medicine including rifampicin, phynytoin, Propranolol, Theophylline
5. Hypersensitivity on herbal medicine

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics parameters of Piperine 0,0.5,1,2,3,4,6,9,12,18,24,48 hour Piperine content is determined by LC-MS/MS. Then,the pharmacokinetics parameters was calculated by c

Secondary Outcome Measures

Name	Time	Method
no no no