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

Phase 1

Completed

• Conditions: Osteoarthritis
• Interventions: Drug: Sahastara remedy alcoholic extract

• Registration Number: NCT02568059
• Lead Sponsor: Thammasat University

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.

Study Timeline

• Study First Submitted: 2015-09-30
• Study First Submitted QC: 2015-10-02
• Study First Posted: 2015-10-05
• Study Start: 2015-12
• Primary Completion: 2016-09
• Study Completion: 2016-09
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-17
• Last Update Posted: 2016-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
200 mg SHT extract	Sahastara remedy alcoholic extract	The Sahastara remedy alcoholic extract capsule dose 200 mg.
100 mg SHT extract	Sahastara remedy alcoholic extract	The Sahastara remedy alcoholic extract capsule dose 100 mg.

Primary Outcome Measures

Name	Time	Method
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	14 days after stop intervention	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

Trial Locations

Locations (1)

Faculty of Medicine, Thammasat University; 🇹🇭 Klongnueng, Pathumthani, Thailand