NCT02568059

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Dec 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 30, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 5, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2015

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

October 18, 2016

Status Verified

October 1, 2016

Enrollment Period

9 months

First QC Date

September 30, 2015

Last Update Submit

October 17, 2016

Conditions

Osteoarthritis

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (2)

100 mg SHT extract

EXPERIMENTAL

The Sahastara remedy alcoholic extract capsule dose 100 mg.

Drug: Sahastara remedy alcoholic extract

200 mg SHT extract

EXPERIMENTAL

The Sahastara remedy alcoholic extract capsule dose 200 mg.

Drug: Sahastara remedy alcoholic extract

Interventions

Sahastara remedy alcoholic extractDRUG

comparison of different dose of drug

100 mg SHT extract200 mg SHT extract

Eligibility Criteria

Age20 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine, Thammasat University

Klongnueng, Changwat Pathum Thani, 12120, Thailand

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Puritat Kanokkangsadal, M.Sc.

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department of Applied Thai Traditional Medicine, Faculty of Medicine

Study Record Dates

First Submitted

September 30, 2015

First Posted

October 5, 2015

Study Start

December 1, 2015

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

October 18, 2016

Record last verified: 2016-10

Locations

TH(1)