MedPath

A clinical trial to test the safety of a herbal drug.

Phase 1
Completed
Registration Number
CTRI/2017/11/010352
Lead Sponsor
SK Biolabs
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
100
Inclusion Criteria

Adult healthy human volunteers.

Exclusion Criteria

Patients suffering from any disease.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Any toxic side effects by keeping SKBOM on tongue such as nausea, vomiting, fever, trouble swallowing, weakness, palpitations, stomach upset, stomach gas, heartburn, skin rashes, dizziness, fainting, depression, anxiety, constipation, diarrhea, dark stool, urinary problems, pain, cramps etc.Timepoint: 1 hour
Secondary Outcome Measures
NameTimeMethod
Any toxic side effects by keeping SKBOM on tongue such as nausea, vomiting, fever, trouble swallowing, weakness, palpitations, stomach upset, stomach gas, heartburn, skin rashes, dizziness, fainting, depression, anxiety, constipation, diarrhea, dark stool, urinary problems, pain, cramps etc.Timepoint: 15 days
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