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

NCT ID: NCT02568059

Last Updated: 2016-10-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-31
• Study Completion Date: 2016-09-30

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.

Conditions

Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

100 mg SHT extract

The Sahastara remedy alcoholic extract capsule dose 100 mg.

Group Type: EXPERIMENTAL

Sahastara remedy alcoholic extract

Intervention Type: DRUG

comparison of different dose of drug

200 mg SHT extract

The Sahastara remedy alcoholic extract capsule dose 200 mg.

Group Type: EXPERIMENTAL

Sahastara remedy alcoholic extract

Intervention Type: DRUG

comparison of different dose of drug

Interventions

Sahastara remedy alcoholic extract

comparison of different dose of drug

Intervention Type: DRUG

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Thammasat University

OTHER

Sponsor Role: lead

Responsible Party

Puritat Kanokkangsadal

Department of Applied Thai Traditional Medicine, Faculty of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Puritat Kanokkangsadal, M.Sc.

Role: PRINCIPAL_INVESTIGATOR

Department of Applied Thai Traditional Medicine, Faculty of Medicine, Thammasat University

Locations

Faculty of Medicine, Thammasat University

Klongnueng, Changwat Pathum Thani, Thailand

Countries

Thailand

Other Identifiers

TCTR20150917001

Identifier Type: REGISTRY

Identifier Source: secondary_id

MTU-EC-TM-1-179/57

Identifier Type: -

Identifier Source: org_study_id