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

Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02568059
• Other study ID #: MTU-EC-TM-1-179/57
• Secondary ID: TCTR20150917001
• Status: Completed
• Phase: Phase 1
• First received: September 30, 2015
• Last updated: October 17, 2016
• Start date: December 2015
• Est. completion date: September 2016

Study information

• Verified date: October 2016
• Source: Thammasat University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Human Research Ethics Committee of Thammasat University No.1 (Faculty of Medicine)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 45 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

Drug:
• Sahastara remedy alcoholic extract
comparison of different dose of drug

Locations

Country	Name	City	State
Thailand	Faculty of Medicine, Thammasat University	Klongnueng	Pathumthani

Sponsors (1)

Lead Sponsor	Collaborator
Thammasat University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	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	Yes
Primary	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	Yes