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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02568059

Enrollment

Registered

2015-10-05

Start date

2015-12-31

Completion date

2016-09-30

Last updated

2016-10-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis

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.

Interventions

DRUGSahastara remedy alcoholic extract

comparison of different dose of drug

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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 while using intervention	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

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026