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

A phase 1 clinical trial for assessment of safety of a multi component botanical therapeutic SKBOM.

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2017/11/010352

Enrollment

100

Registered

2017-11-02

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

None listed

Interventions

Intervention1: SKBOM: Keep 100-200 mgs of SKBOM on tongue and allow to dissolve slowly in oral cavity. Repeat this 4-5 times per day continuously for 15 days. Control Intervention1: No comparator agen

Eligibility

Inclusion criteria

Inclusion criteria: Adult healthy human volunteers.

Exclusion criteria

Exclusion criteria: Patients suffering from any disease.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Countries

India

Contacts

Public ContactDr Ashok Kumar

SK Biotherapeutics Pvt. Ltd. (Previously SK Biolabs)

ashok846@gmail.com8126688922

Outcome results