A trial to test the safety of a herbal formulation

Phase 1 clinical trial for assessment of safety of a multi component botanical formulation SKBSHYAM

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2018/01/011439

Enrollment

100

Registered

2018-01-19

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: SKBSHYAM: Apply formulation on skin for 15 minutes daily for 30 days. Control Intervention1: No comparator agent: Not applicable

Eligibility

Inclusion criteria

Inclusion criteria: Healthy human volunteers

Exclusion criteria

Exclusion criteria: Patients suffering from any disease.

Design outcomes

Primary

Measure	Time frame
Any toxic side effects after application of SKBSHYAM on skin such as irritation, redness, inflammation, edema, urticaria, fever, vomiting, nausea, faintness, cough, rashes etc.Timepoint: 30 minutes	—

Secondary

Measure	Time frame
Any toxic side effects after application of SKBSHYAM on skin such as irritation, redness, inflammation, edema, urticaria, fever, vomiting, nausea, faintness, cough, rashes etc.Timepoint: 1 month	—

Countries

India

Contacts

Public ContactAshok Kumar

SK Biotherapeutics Pvt. Ltd. (Previously SK Biolabs)

ashok846@gmail.com8126688922

Outcome results