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

Study Overview
=================
Brief Summary
-----------------
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.

Detailed 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.

Official Title
-----------------
The Clinical Safety of Alcoholic Extract Sahastara Remedy of Extract Capsule in Healthy Volunteers (Clinical Trial Phase I)

Conditions
-----------------
Osteoarthritis

Intervention / Treatment
-----------------
* Drug: Sahastara remedy alcoholic extract


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 100 mg SHT extract<br>The Sahastara remedy alcoholic extract capsule dose 100 mg. | Drug: Sahastara remedy alcoholic extract<br>* comparison of different dose of drug<br>|
| Experimental: 200 mg SHT extract<br>The Sahastara remedy alcoholic extract capsule dose 200 mg. | Drug: Sahastara remedy alcoholic extract<br>* comparison of different dose of drug<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical safety evaluated by History taking, Patient diary note, Physical Examination and Laboratory test including Complete Blood Count (CBC), Renal functions, Liver functions, Lipid profile, Fasting Blood Sugar (FBS), and Urinary analysis | Clinical safety was evaluated changing from baseline by History taking, Patient diary note, Physical Examination and Laboratory test including Complete Blood Count (CBC), Renal functions, Liver functions, Lipid profile, Fasting Blood Sugar (FBS), and Urinary analysis | 14 days while using intervention | 
| Clinical safety evaluated by History taking, Patient diary note, Physical Examination and Laboratory test including Complete Blood Count (CBC), Renal functions, Liver functions, Lipid profile, Fasting Blood Sugar (FBS), and Urinary analysis | Clinical safety was evaluated changing from baseline and 14 days while using intervention by History taking, Patient diary note, Physical Examination and Laboratory test including Complete Blood Count (CBC), Renal functions, Liver functions, Lipid profile, Fasting Blood Sugar (FBS), and Urinary analysis | 28 days while using intervention | 
| Clinical safety evaluated by History taking, Patient diary note, Physical Examination and Laboratory test including Complete Blood Count (CBC), Renal functions, Liver functions, Lipid profile, Fasting Blood Sugar (FBS), and Urinary analysis | Clinical safety was evaluated changing from baseline,14 days and 28 days while using intervention by History taking, Patient diary note, Physical Examination and Laboratory test including Complete Blood Count (CBC), Renal functions, Liver functions, Lipid profile, Fasting Blood Sugar (FBS), and Urinary analysis | 14 days after stop intervention |