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 SKB108.

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2017/10/010237

Enrollment

100

Registered

2017-10-27

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: SKB108: Orally administered 400 mgs capsule /25 kg body weight/day of SKB108 continuously for 6 months Control Intervention1: No comparator agent: Not applicable

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 after oral administration of SKB108 capsules such as Fever / Weight gain / Weight loss / Feeling sickly / Headache / Unusual fatigue / Swollen glands / Loss of appetite / Skin rashes / Unusual bleeding / Pain in chest / Palpitations / Trouble swallowing / Heartburn or stomach gas / Stomach pain / Nausea /Timepoint: 1 month	—

Secondary

Measure	Time frame
Any toxic side effects after oral administration of SKB108 capsules such as Fever / Weight gain / Weight loss / Feeling sickly / Headache / Unusual fatigue / Swollen glands / Loss of appetite / Skin rashes / Unusual bleeding / Pain in chest / Palpitations / Trouble swallowing / Heartburn or stomach gas / Stomach pain / Nausea etc.Timepoint: 6 months	—

Countries

India

Contacts

Public ContactAshok Kumar

SK Biotherapeutics Pvt. Ltd. (Previously SK Biolabs)

ashok846@gmail.com8126688922

Outcome results