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

Thammasat University

Status and phase

Completed

Phase 1

Conditions

Osteoarthritis

Treatments

Drug: Sahastara remedy alcoholic extract

Study type

Interventional

Funder types

Other

Identifiers

NCT02568059

TCTR20150917001 (Registry Identifier)

MTU-EC-TM-1-179/57

Details and patient eligibility

About

The clinical safety of Sahastara remedy alcoholic extract in healthy volunteers. Investigators will investigate safety of 100 and 200 mg of Sahastara remedy extract capsule in healthy volunteers. This is Clinical trial Phase I.

Full description

The sahastara remedy (SHT) is a Thai traditional medicine that is use to relieve pain of musculoskeletal problem. There is study shown that SHT extract was not found acute and chronic toxicity in rat. However, there is no study regarding safety in human. Thus, this study is a clinical trial Phase I that investigate clinical safety of SHT alcoholic extract in healthy volunteers. The clinical safety will monitor for 28 days in continuously use of 100 and 200 mg SHT extraction 3 time a day and after stop intervention for 14 days.

Enrollment

25 patients

Sex

All

Ages

20 to 45 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

No pregnancy
No Serious Medical Condition evaluated by Physical Examination and Laboratory results in 1 month before study
No Supplementary food and/or Vitamin during the study
Able to follow suggestion during the study

Exclusion criteria

Uncontrolled Hypertension (BP>140/90 mm.Hg.)
BMI > 30
Have serious medical condition including Severe peptic ulcer, congestive heart disease, Liver and Renal dysfunction.
On during use medicine including Rifampicin, Phenytoin, Propranolol, Theophylline