A trial to test the safety of a drug

Phase 1 clinical trial for assessment of safety of a multi component botanical therapeutic (SKBDEVI) in healthy human volunteers

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2017/12/010788

Enrollment

100

Registered

2017-12-06

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: SKBDEVI: Dose: 500 mgs capsule Frequency:Every 3-4 hours Route of administration: Oral Duration of therapy: 3-4 weeks 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 oral intake of SKBDEVI such as fever, nausea, vomiting, headache, depression, irritation, anxiety, palpitation, choking, fainting, cough, skin rashes etc.Timepoint: 1 day	—

Secondary

Measure	Time frame
Any toxic side effects after oral intake of SKBDEVI such as fever, nausea, vomiting, headache, depression, irritation, anxiety, palpitation, choking, fainting, cough, skin rashes etc.Timepoint: 4 weeks	—

Countries

India

Contacts

Public ContactAshok Kumar

SK Biotherapeutics Pvt. Ltd. (Previously SK Biolabs)

ashok846@gmail.com8126688922

Outcome results