A trial to test the safety of a drug.

Phase 1 clinical trial for assessment of safety of a multi component botanical therapeutic SKBSITA

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2017/11/010680

Enrollment

100

Registered

2017-11-28

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: SKBSITA: Dose: Two 500 Mgs capsules (equivalent to 5 Gms whole powder)

Frequency: Every three-four hours

Route of administration: Oral

Duration of therapy: Minimum 15 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 oral administration of SKBSITA such as fever, nausea, vomiting, cramps, headache, stomachache, backache, palpitations, dizziness, paralysis,skin rashes, choking, numbness, anxiety, depression, cough, shortness of breath etc.Timepoint: 4 Hours	—

Secondary

Measure	Time frame
Any toxic side effects after oral administration of SKBSITA such as fever, nausea, vomiting, cramps, headache, stomachache, backache, palpitations, dizziness, paralysis,skin rashes, choking, numbness, anxiety, depression, cough, shortness of breath etc.Timepoint: 15 days	—

Countries

India

Contacts

Public ContactAshok Kumar

SK Biotherapeutics Pvt. Ltd. (Previously SK Biolabs)

ashok846@gmail.com8126688922

Outcome results